Fully Customizable CAPA Form

When it comes to a business or organization, productivity is everything. The more productive you're in all areas of your company the more successful you will be in the future. Fortunately, CAPA - Corrective and Preventative Action - can help!

 

What is the definition of CAPA Software?

 

It is an abbreviation of corrective action and preventative action software which can be considered a vital tool designed for any business quality management system. In simple words, this is a kind of software that allows personnel to record and keep track of corrective action requirements in whatever form they take. Such software can be used to track customer service complaints, employee complaints, supplier non-conformance, or virtually anything else which needs deliberate action.

 

It keeps the issues extremely visible in order to force the user to solve them. It also allows the user to connect relevant images or other information in order to better organize the corrective action requirements. By allowing the linking of information, contacts, and cross-references, the software helps the user determine the right course of action and therefore the proper personnel to notify.

 

Below are the defining steps of the CAPA system include –

 

(i) Root Cause Analysis: This is the primary step to the application of the CAPA process, and it's to do with laboratory analysis or a close audit of documents that relate to the problem or complaint. This identifies the particular problem for the later stages of the process.

 

(ii) Identification and Adaptation of Corrective Action: These are the immediate steps to address a present complaint; which may have to do with product replacement, and various steps to provide relief to any persons directly affected by a faulty product.

 

(iii) Development and Adaptation of Preventive Action: In CAPA for Pharma, developing a preventive action indicates the various steps for addressing a complaint or discrepancy on a long term basis. This may include decisions like a product recall, or rectification of a regular system.

 

(iv) Implementation of Preventive Action: The final stages to the CAPA Medical Device, implementing a preventive action ensures that future incidents relating to a complaint or discrepancy are prevented.

 

In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The one and the only company that provides integrated software for quality management (QMS) and ALM (Design Control) combined with regulations compliance. ORCANOS CAPA (Corrective Action and Preventive Action), as a part of Orcanos QMS, ensure regulations compliance, while automating the CAPA process completely, from initiation to investigation and closure. With years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers makes Orcanos unique from others.

 

For more details and to know about Orcanos or more please, call us at +972- 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

Integrated Quality Management System

An Integrated Management System (IMS) combines other International Standards, such as Quality Management System (QMS), Environmental Management System (EMS), and workplace safety management (OHSAS). The aim is to deliver a coherent overall management package that helps an organization meet its requirements and deliver on-time quality products and services. Some of the immediate benefits an optimum quality system can offer any business include:

 

• Quick return on investment
• Significant administrative time and cost savings
• Increased chances of market success
• Solid infrastructure for a robust system that supports quality-related tasks and processes throughout the organization

 

Every business faces the challenge of ensuring the entire quality management system is well connected between departments and teams. One of the sure ways of optimizing a quality system is to have all quality processes connected through a central system and removing silos of information throughout the company. It's a common occurrence that during an audit or survey, a change in the process or non-conformance is highlighted. A process change may impact three to four departments, therefore, having a centralized system that triggers a required action, based on an identified issue, and would save man-hours in transcribing the findings and then communicating to each stakeholder separately.

 

In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The one and the only company that provides integrated software for quality management (QMS) and ALM (Design Control) combined with regulations compliance. With Orcanos 72 Hours to Automate Document Control, you can be assured that no document is overlooked, and document cycle time is reduced significantly while assuring compliance with regulations.

 

With years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers makes Orcanos unique from others. One of the major benefits of an IMS is to reduce duplication and risks, which leads to a reduction in costs and an increase in profitability. It helps build relationships rather than conflicting responsibilities.

 

An Integrated Management System ISO brings many benefits. An ISO IMS is a very important business and management tool, helping to reduce costs and increase profits. And for individual businesses, it can help in the search for new markets and increase customer satisfaction.

 

But best of all, it means everyone within the organization is singing from the same hymn sheet and working towards the same goal, and that has to be a win-win result!

 

A good quality management system in a pharmaceutical company can significantly improve the net profit status, best quality medicines for patients, less rework and recall which save extra money, good work environment, and compliance with local and international regulations.

 

For more details and to know about Orcanos or more please, call us at +972- 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

Importance of Bug Testing Software in Software Development

Quality assurance is the most important factor in any business or industry, and the software development industry is no exception. For getting appropriate quality output in software development it is important that the software quality assurance process be followed in each phase (Planning, Requirement Analysis, Design, Development, Integration, Implementation, and Maintenance) of the software development lifecycle.

The quality of a software product can be ensured only by effective bug testing. In the competitive market, only a quality product can exist for a long time.

There are several reasons why Bug testing software is important.

• In case of manual testing, there will be a lot of possibilities for human errors such as wrong input data due to typos, ignorance of the actual behavior of the system, some test case executions being overlooked, or left out.
• Another important factor is that the software will generate scripts that can be used as a way of storing project knowledge gained by the engineers. This will help the new software engineer gain project knowledge to enhance/update the automation scripts further.
• It should also have the feature for storing screenshot of each and every page navigated during the execution. So that it can be used as a proof for automation.
• The very important advantage of using the software over manual testing is execution speed. Script execution can be completed quickly. So ultimately the total time needed can be reduced which will significantly help for timely project completion.
• It is also very helpful in comparing large amounts of data between a previous version and the current version as a part of regression testing. Practically it may not possible to do it manually.

In the world of business, the computer has become more of a necessity than ever before. With businesses so dependent on computers the need for software to run on these computers is also in high demand. In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The one and the only company that provides integrated software for QMS System (QMS) and ALM (Design Control) combined with regulations compliance.

Benefits

• Single Repository for R&D Quality And Regulations
• Document Generation
• End-To-End Traceability
• Impact Analysis
• Just Start Working

Moreover, our years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers make Orcanos unique from others.

Bug Testing Software plays a very crucial part in the software development industry by improving the overall bug testing process thereby helping the organizations deliver high-quality products to their valued customers and end-users.

 For more details and to know about Orcanos or more please, call us at +972- 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

72 Hours to Automate Document Control

Document version control software is something that many companies employ to arrive at and maintain compliance with industry standards because the amount of money of data and information flowing through businesses keeps growing, and agencies such as the FDA and ISO will expect companies to trace every change that any user makes to the given document.

 

Many companies waste numerous time and expense searching through countless documents and unstructured information. This is detrimental in a couple of ways. One, it makes it very hard to produce the actual versions of the right documents when regulatory agencies demand them. Document version control software to consider good care of these problems, though. These solutions were created to track every change that was made to a document and to control the authorized users so just one person can edit the document at this time. This makes sure the version is correct and also the document will keep its integrity and transparency. It will stay in a centralized and secure location.

 

So how can a document control system save your organization time and costs in the management of critical company information?

 

A document control system software usually is the repository of documents that provides secure control of all documentation in the organization. With this type of software, you can improve communication, traceability, compliance, and control over key business processes.

 

To highlight a few ways in which an electronic document control system can assist a business, we've listed some ways here:

Easy Search and Retrieval

 

The first advantage of automating document control is going paperless.

 

Quick Process Approval

Using document control software allows you to send your documents electronically and assign different rights to the concerned manager.

 

Effective Information Management

Electronic control of documents will ensure your customer service and sales teams are accessing the most current information and constantly sharing that with prospective clients and customers.

 

Regulatory Compliance

 

When dealing with regulatory authorities, having the right information available at the right time can prove very useful for the business.

 

With the growth of technology and increasing demand for electronic document management system software, an organization of any size can easily find a solution that will fit into their business need and their budget. In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The one and the only company that provides integrated software for quality management (QMS) and ALM (Design Control) combined with regulations compliance.  With Orcanos 72 Hours to Automate Document Control, you can be assured that no document is overlooked, and document cycle time is reduced significantly while assuring compliance with regulations. With years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers makes Orcanos unique from others.

 

For more details and to know about Orcanos or more please, call us at +972- 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

Why You Should Use an Electronic Quality Management System?

Today's fast-paced social and business dynamics will need business establishments to have proper management in document archiving. Most companies solve these issues by employing electronic document management services.

 

What are the benefits of electronic Quality management systems?

 

• Easy access: Thanks to the advanced search function, as well as the unique barcode system, accessing specific documents is both fast and simple.
• Improved workflow: Because documents are easily accessible, a faster and more productive workflow is possible. Employee productivity will be greatly improved.
• Lower IT costs: Since most EDM systems integrate with other common programs and systems within a business, IT costs can be kept to a minimum.
• Record backups: Electronic document management systems allow for maximum document control, especially in the case of an emergency. If a certain document is lost or damaged, a backup can be easily retrieved by the EDMS.
• Space-saving: There is no real need for the storage or archiving of hard-copy documents when you have an EDMS. This means that you save both space and money.

If you are interested in having one installed within your business, be sure to contact a reputable document management and solutions company for professional assistance. Orcanos is one of the leading and most reputable companies that have many years of experience providing integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, and specializes in the medical device industry. The software named Orcanos was founded in 2005 by Zohar Peretz and Rami Azulay. Our ability to tailor custom solutions using our vast experience and expertise, together with an integrated ALM and quality management system, sets Orcanos apart from other vendors and consulting bodies in the ALM and quality management domain.

 

Orcanos quality management system keeps all the data required to manage the quality processes in a single point of access. It enables companies to eliminate paper-based quality processes while following strict FDA regulations and ISO quality standards. The thing which makes us unique from others is our years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers and other advanced corporations and assisting them in building their operational excellence.

 

This management system could very well replace the old-fashioned filing cabinets that are stuffed with file folders and papers. Today, people in legal, government, medical, corporate offices are storing and retrieving documents by computerized systems. This conversion also results in an environmentally friendly storage process. It can make your duties easier, faster, and more cost-efficient.

 

To make a long story short, implementing a good quality electronic document management software system is an excellent investment that will yield great returns for your business.

 

For more information or to know more about ORCANOS and the products or more please visit our website here; https://www.orcanos.com/compliance/

How CAPA MANAGEMENT SOFTWARE Can Help Your Business To Succeed?

Today, compared to any other area of quality management, CAPA is causing more compliance troubles for life sciences companies or organizations. According to the recent reports, nearly more than 83% of the warning letters are cited CAPA as an area of non-compliance even though most of the organizations were non-compliant in one or more areas. By considering the above factors, it is clear that your organization need a specialized software application for the management of CAPA because in most of the cases when an organization receive a warning letter, it means that the technology was in place but it failed for one or another reason.

 

But What Is CAPA Management?

The term CAPA stands for “Corrective Action and Preventative Action” and the main purpose of the system is to collect information, identify, analyze information and investigate product and quality problems and take appropriate and necessary action plan to prevent their recurrence. The CAPA management system also helps to verify or validate corrective and preventive actions as well as communicating the activities to responsible people by providing relevant information for management review. And then documenting all these activities is also very important if you want to deal effectively with quality and product problems and to minimize device failures and prevent their recurrence.

 

However, today even the paper-based,  home-grown or commercially available electronic management systems may meet minimum requirements of FDA. But as a business owner, if you want your organization to go further than just checking the box and want to capture and expand your market share then you have come to the right place. Orcano's CAPA MANAGEMENT SOFTWARE is a well designed comprehensive yet easy to use software system which is used to effectively manage your organization’s corrective action and preventive action processes while integrating with other processes. Managing these processes is very important in order to regulatory compliance such as change control, non-conformance, audits and customer complaints. As part of Quality Management System (QMS), Orcanos CAPA management software ensure regulations compliance, while completely automating process right from the initiation to investigation and closure which will greatly help you get more business.

 

Here are some of the following features of Orcanos CAPA system which includes:

• Best Corrective and Preventive Action Management
• Secured, centralized and electronic web-based system
• Traceability matrix to various quality processes such as FMEA, Training, Verification, ECO, Complaints etc.
• Prioritization
• Smart dashboards
• Action planning and root-cause management
• 21 CFR Part 11 compliant
• E-sign automation and workflow

 

Orcanos is one such platform which can help your business to convert each and every issue into an opportunity for improvement. And our highly designed Orcanos CAPA management software system is integrated with Orcanos e-QMS to support medical device compliance.

 

To know other details & information about ORCANOS please visit our website here: https://www.orcanos.com/compliance/

FMEA RISK MANAGEMENT And How It Helps In Managing Risk?

We all know that, for any organization to be successful in the market, identification of risk and eliminating the same is very important. The process of identifying and assessing risks and its various impacts followed by actions to minimize and control the impact of unfortunate events is called risk management. These risks can come from any field of business like uncertainty in finance, failure in projects, accidents, legal liabilities, etc. Various organizations follow different methods to find out the risks involved in a process. FMEA (Failure mode and effects analysis) is a step-by-step approach for identifying all possible failures in a design, a producing or assembly process, or a product or service.

identify the probable risk involved in a process. Now it has become essential for organizations to identify the risk and manage suitably to avoid huge financial losses.

Five ways FMEAs help manage risk

1. They start by providing a framework to develop a comprehensive identification of potential risks.
2. They assist with the evaluation of those risks in terms of how severe they could be, their likelihood of occurring, and the chance the potential failure has to be detected before failure.
3. They are a tool to decide which are the most serious risks.
4. They help point to ways to reduce the most serious risks.
5. They enable reevaluation to determine if the risk has been sufficiently reduced or if more work needs to be done.

To achieve an appropriate level, the session takes a broad view of the end-to-end supply chain - how to map it and identify the typical 'pressure points' where issues and risks are likely to occur. The focus is on identifying the risks from multiple perspectives by achieving true cross-functional and cross-company involvement and buy-in. The output from this becomes the input to a risk assessment exercise such as FMEA, the construction of which is explored.

So why should you use it?

FMEA is a tool to ensure that you have captured all possible causes and failure modes of your system. Ultimately, this system is effective at identifying and correcting process failures early on so that you'll avoid the nasty consequences of poor performance.

In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The one and the only company that provides integrated software for quality management (QMS) and ALM (Design Control) combined with regulations compliance. Orcanos Risk Management is meant to help medical device manufacturers to identify, track, and mitigate potential risks before they happen.. By using one system that connects design control, risk, and Quality Management, you'll reduce risk of failure, ensures hazards are mitigated, and prevents failure from happening .With years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers makes Orcanos unique from others.

For more details and to know about FMEA Risk Management Tool or more please, call us at +972- 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

Which Software Asset Management Tool Works Much Better For All Assets Of A Firm?

To manage every software asset belonging to a firm, you need a tool that can handle all the different types of software and their skills. More than that, it should provide features and perks mentioned below:

Real-time dashboards with alerts 

Depend on that tool, which can help visualize the content or the usability of a firm’s software asset effectively. In addition to that, put the alerts on to get the timely notifications about the updates. The improvements in the same visualizations hung up on the dashboard of a project analysis related to a single or multiple software.

These alerts are necessary to stay updated with the market trends. This is one of the vital roles of having a Agile Requirements Management Tools in your firm. Without the latest trends, you won’t know if the software you are using is enough for the project you run or the products you sell.

Owns up a central repository for every software and risk management sheets

Have a tool that can easily integrate all the data files into one place. You don’t want to depend on multiple software for conducting a quality analysis of thousands of other software. That would just be cumbersome and render no benefit to anyone at all.

Thus, have a single software that can run multiple projects at once, or else, it can store all the project files in a central repository. With this, the task to edit, retrieve, download, or share the results becomes easier for the firm's software asset management officers or supervisors.

It should generate the required documents related to the risk, success, and failure of any software

Find that tool that can easily generate the reports for an easy explanation to the senior management. If you are a project manager, you must know that working on a tool or software isn’t the only task.

You need to be able to explain to your seniors or the stakeholders about the risk, success, as well as causes of failure. And at times, graphics are not enough. You need to have proper case studies, or the sheets tracing the entire project from day one.

That is why generating documents is quite necessary for those software asset management tools to work for a long run in the organization.

Can help integrate different modules

Whenever you are developing a software or testing its quality, you are working on multiple functions of an organization.

This includes R&D, cost analysis, risk analysis, and quality checks. Therefore, you need a tool that can integrate the results or the inputs to be drawn from each department to know what type of software is the requirements management tools dealing with.

Conclusion:

Browse this site https://www.orcanos.com/compliance/products/requirements-management/  to get the latest tool helping every organization in timely software asset management provided by Orcanos.

Top 3 Considerations While Working With A Best Document Management System

Being a new-age and smart organization owner, you might want to serve all your clients with the utmost efficiency. And it is pretty simple by automating operational tasks using modern software tools. The Document Management System is also known as DMS is the most important and widely used application by many organizations all over the world. Gone are those days when the organization depends upon the use of piles of papers, files and folders to manage their documents in the business. The document management system revolutionizes the way you manage your business documents. So, go paperless by implementing a versatile document management system and prove to the world that you are a progressive entrepreneur.

What is a Document Management System?

A Document Management System (DMS) is a digital application that is used to store all your business records and provides you and your staff with the best portal to access all those records. There are several other names that are used to describe similar applications such as electronic document management system, enterprise document management system, records management system, content management system and many more. And all these applications pretty much do the same thing so you don’t have to sweat the jargon.

Today, in order to run a successful business, having secure access to and storage of digital information is very important and a Document Management System Software can help you by providing the software solutions that greatly provide access to your digital information or data in an easy and most effective way. With so many different software options available, getting a good document management system can be nerve-wracking and a daunting task. So, following are the top 3 key considerations that you need to consider while choosing and working with a document management system which includes:

• Security: When selecting a good document management system to work with, along with easy access, security is also an important aspect of a DMS and you need to make sure that they are also secure.
• Compatibility: When you buy a DMS, you need to make sure that it is compatible with the existing systems and integration must be seamless and without any jerks.
• Quality: You need to know about the company that makes DMS and choose only those products that are done well and got good reviews.

Orcanos is the one such company who have their previous products done well and have gotten very good reviews from the clients. Now you can reduce bottlenecks on documents routing and signoff by choosing our well-designed document control software. Therefore, if you’re someone who's looking for the best DMS software for your business then choose Orcanos fast and swift document management systems and become a trendsetter. For more information to know about ORCANOS please visit our website here: https://www.orcanos.com/compliance/

Importance Of Choosing Orcanos CAPA System Integrated with ORCANOS e-QMS

The Corrective and Preventive Action also known as CAPA is the most important tool that is utilized by many organizations worldwide to identify, avoid and resolve non-conformances. CAPA also defined as the improvements made to an organization’s processes taken to eliminate causes of undesirable situations and non-conformities. In an attempt to prevent their recurrence for corrective action or preventive action, it focuses on the systematic investigation of the root causes of identified risks or problems. Just the way it sounds, the CAPA management system consists of two main elements that are corrective and preventive action and both these actions have one main aim that is to improve the quality of processes. Although CAPA processes have been employed by many organizations all over the world, they have been evolved correspondingly with the advancement in the new technologies and strategies.

Today, it has become a common tool to be integrated with many applications in IT architecture and it also plays a very crucial role in the global quality management system initiatives. According to the report, it is said that in the recent year, more than 83% of warning letter has been cited CAPA as an area of non-compliance at FDA regulated organizations or companies, even though most of these organizations were noncompliant in one or more areas such as CAPA purchasing controls or process validation requirements. So, by considering the above factors, it is clear that organizations need to have a specialized robust software application for CAPA management system or an electronic quality management system (eQMS). In this article, we will discuss the main elements of Orcanos CAPA system is integrated with ORCANOS e-QMS to support medical device compliance.                 

Orcanos is one of the leading and most reputable company that have many years of experience providing complete automation of the CAPA process in Orcanos quality management system (QMS). As part of Orcanos QMS, Orcanos Corrective Action and Preventive Action (CAPA) ensure regulations compliance while completely automating CAPA process from the beginning stage that is an initiation to investigation and closure. Orcanos CAPA Management Software includes the most secured and centralized web system and also have traceability to other quality processes such as FMEA, verification, ECO, Complaints, Training etc. Today, the first-in-first-out methodology for CAPA has been used to reduce non-conformances and this is the reason, it is becoming more common for many companies worldwide to integrate CAPA and non-conformance reporting modules with electronic quality management system (eQMS) and many QMS solutions have this built-in capability.

In order to support medical device compliance, Orcanos CAPA system is integrated with Orcanos e-QMS. No matter whether it has risk associated or a resolution requires an engineering change, Orcanos links the quality management artefacts using traceability tool and strives to provide impact analysis and better tracking. To know more details and other information about ORCANOS please visit our website here: https://www.orcanos.com/compliance/

Document Management Software - Keeps Your Business data secure

In business, there is tons of paperwork that needs to be filed and kept properly for documentation purposes. Oftentimes, there are problems in finding misplaced papers that cause more delays in the transaction. But in the advent of technology, document management software is now utilized to solve these types of problems.

What is document management software?

Document management software is a tool used to systematize your files. Instead of keeping tons of papers and searching each one for a single file, the software saves a digital copy of the file through the use of a scanner. It will then be saved on the computer. You can share the files with your colleagues so that you can work together, making the completion of a task faster. If you want to know how and why document management software can be useful to your business, here are the top reasons I summarized for you:

• Faster search options
• It allows you to regulate the distribution of files.
• It reduces the need for storage.
• It has disaster recovery features.
• It can help you save money and time.

Securing business data is again a very big concern in paper documents. Not only are paper files at risk of misplacing, they're also vulnerable to theft and physical damage. Although digital documents to are susceptible to physical damage, the simple backup and recovery eliminate this problem very effectively. Apart from this, the access system in document management software allows only authorized personnel to access the files. Similarly, different levels of security are often set up depending on the need. For instance, a file may be read-only for a department, whereas modification or update rights can be given to higher management or others as required.

Choosing the proper business document management system specific to your business requirements is extremely important. Orcanos is one of the leading and most reputable companies that have many years of experience providing integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, and specializes in the medical device industry. The software named Orcanos was founded in 2005 by Zohar Peretz and Rami Azulay. Our ability to tailor custom solutions using our vast experience and expertise, together with an integrated ALM and quality management system, sets Orcanos apart from other vendors and consulting bodies in the ALM and quality management domain.

By automating document workflow, Orcanos software can assure that no document is overlooked, and document cycle time is reduced significantly while assuring compliance with regulations. The thing which makes us unique from others is our years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers and other advanced corporations and assisting them in building their operational excellence.

To know more details and other information about ORCANOS please visit our website Here; https://www.orcanos.com/compliance/

ISO 14971:2019 Compliance: Trace to design control mitigations

The ISO 14971 is an ISO standard for those companies involved in the manufacturing of medical devices. It intended for improving company processes and standardizes manufacturing procedures so that the risks associate with electronic medical devices can be mitigated. It is a set of points for risk management and adopting best practices while developing a device used in the medical industry.

There are three different versions of the ISO 14971

ISO 14971:2007- This was the first standard that was made by the world governing body for medical devices. It was replaced by the ISO 14971:2019.

ISO 14971:2019- It replaced the ISO 14971:2007 certification. It has new chapters included in it and focuses mainly on the benefit-risk ratio. It also includes information that has to be passed on to the next phases for safer use of the device.

EN ISO 14971:2012- It is intended for manufactures of medical devices in Europe only.

The ISO 14971:2019 has three main objectives

Implementing the safety standards right fro he planning phase of manufacturing

Designing medical devices is a complicated process. This feature as stated within the ISO Document Control Software is to mitigate the hazards in the medical industry by use of safe manufacturing process. It deals with removing those features that could be selected by mistake or by error.

The safety while using the medical devices can also be increased by the use of labels and displays beside each switch, plug, or socket. Also, there should be a process to automate the device functions to avoid the error. It can be used for doing the minute tasks where the chances of error are high.  

Include measures to protect or contain the damage within the device itself

This point explains the need to incorporate safety measures in it and also the mechanisms in the event of wrong input. These may include safety measures such as using safety guards, shields, or manual override to contain the activity. It includes providing warning displays to warn the user while using the device such as low battery warnings on devices. This would prevent stalling a device operation midway while conducting surgery or anything similar. 

Safety information

This includes users to hand a device manual which gives a thorough guide on how to use the device. It also includes providing training to the users of the device.

What are the benefits of ISO 14971:2019?

• It can avoid the wrong happenings such as injury or accident
• Optimum use of the device for improving medical infrastructure
• Develop better surgical procedures that focus on the safety of the user and the patient
• Streamlining manufacturing processes and issuing standard guidelines

Orcanos is a risk management tool designed to help medical device manufacturers. It is considered to be the best for providing an integrated solution, providing traceability, and is fully online. Visit the Orcanos website for more details: https://www.orcanos.com/compliance/

Integrated Design Control and QMS

To introduce, ISO 9001 QMS (Quality Management Standard) was designed and introduced by the ISO to help organizations ensure a better quality of products and services to be able to grab a larger market share and ensure greater customer satisfaction. A strong QMS is a necessary part of achieving prime quality to please customers. The QMS aids in making and maintaining the simplest set up of action for doing business. The QMS systems provide a way to deal with problems requiring corrective action and for determinant causes of insubordination. The QMS and audit system also produce a mechanism for implementing preventive actions to eliminate the foundation reason for quality problems. As a result, if the very best quality isn't achieved, the system itself is the instrument for correcting that.

A QMS Quality Management System is required for any organization which desires to demonstrate its ability to consistently provide products that meet both customers' needs and the applicable regulatory requirements. When a Quality Management System; is implemented, it paves the way for an integrated enterprise with interacting processes. This helps in the smooth functioning of the operations resulting in profitability. QMS helps to efficiently control business processes and their interlink ages. Furthermore, it can help you in overcoming market barriers paving the way to fiercely compete in global markets.

Perhaps one of the more important aspects of a QMS is that you'll be able to make continual improvements in how you run your company. From managing your risks better to driving down operating costs, from improving your market share to increase your customer satisfaction, your QMS will provide you with an edge over all your competitors. Also, once you get outside certification for your QMS, particularly for international standards such as the widely used ISO 9001, your business attracts new clients.

In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The only company that provides Integrated Design Control and QMS or Quality Management Software, and ALM (Design Control).Our years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers make us unique from others. At any point, Orcanos enables you to get data into Word documents and e-sign them in Orcanos DMS, or directly sign electronic records

Integrated Design Control and QMS enable all stakeholders, whether its R&D, QA, RA, or management, working with a single repository system that combines it all together document Control, CAPA, Change Control, Risk Management, Requirements Management System, and more. We are also flexible enough to serve SMBs and powerful for enterprises. ORCANOS CAPA (Corrective Action and Preventive Action) ensure regulations compliance while automating the CAPA process completely, from initiation to investigation and closure. To know more about Orcanos or more please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

How To Ensure Integrating Design Control, Quality And Regulation Compliance?

If you own an organization in highly regulated industries such as life sciences, it is important to make sure that everything is dotted and crossed. Today, the US FDA and other regulatory agencies have strict regulations and requirements for document control, integrating design control, CAPA, training and other aspects of the operations. As an organization owner, you have to make sure that your each and every process must support continuous compliance and your organization needs to be ready to respond to any kind of requests for regulatory changes or documentation. If you are someone who is just getting started then ensuring your procedures and processes are complaint can feel like a daunting and overwhelming task. Your organization need to create and implement a well-designed quality management system which can scale.

In this article, we will tell you how to ensure that your organization maintains Integrating Design Control, Quality And Regulation Compliance and the best company that provides all these software tools and services. As an organization owner, you need to know that your organization will be responsible for creating a good quality management system (QMS) which will greatly help you bring products to market that meets the requirements of regulatory agencies and also your customer needs. A quality management system (QMS) is defined as a set of comprehensive business procedures and processes that are designed to meet customer requirements and also create quality products. So, it is very important to ensure that the quality management system should be aligned with regulatory requirements.

Orcanos is the one such leading company that serve high-tech industry-leading companies and specializes in medical device manufacturers. Orcanos provides a continuous real-time audit for medical device and compliance medical device lifecycle management. Our holistic approach supports senior management, R&, and QA/RA. Orcanos Integrating design control software enables medical device manufacturers to provide documented evidence that a well defined and controlled product development and design process is in the right place and has been properly executed and manufactured. This collaborative design control software improves regulatory compliance and design quality through best tools that enable you to record and review design evidence and stay on top of the design history and key activities.

Orcanos Application Lifecycle Management (ALM) provides FMEA  risk management, document management, requirements management, test management and quality management processes and procedures everything on a single respiratory. Orcanos requirements management tool is the one-stop affordable cloud solution for managing and tracking testing and requirements as part of Orcanos integrated ALM and QMS platform. One of the biggest advantages and the great power of Orcanos is in the integration between design control, quality, R&D and regulation. To know more details and information about Orcanos please visit our website here: https://www.orcanos.com/compliance/

Benefits of implementing the QMS

Companies that are involved in designing and manufacturing of any types of devices need to adopt the quality management system into their organization. As the name suggests, the quality management system is a set of policies and procedures aimed to make sure the right product quality.

Adopting the set of rules stated in the quality management system abbreviated as QMS helps to manufacture goods that are of the optimum quality and homogeneous.

Is there any standard available for QMS?

The basic standard has been set by ISO (International Organization for Standardization) in the ISO 9001:2015. It specifies in detail what the scope of the QMS Quality Management System is. All the companies, industries, and factories must adopt to these sets of rules for meeting the standards set by the ISO.

QMS is a very broad concept and so there are other series of ISO standards that focus on certain aspects of QMS. The ISO 14000 series is improving environmental management systems, ISO 13485 for maintaining QMS for medical devices, ISO 19011 audit management systems, etc.

There are many benefits of implementing the ISO.

• It helps to meet the requirement of your customers and clients. This gives confidence to the customer that your product is safe to use and thus they eventually become hooked to your set of products.
• It ensures making the best quality products at the optimum cost. Thus adopting the ISO is beneficial for cost-cutting and improving profit and revenues.
• It helps to identify, define and improve the process involved in manufacturing and designing
• It makes sure that there are no mistakes during the product manufacturing process and all the products are alike.
• Adopting the QMS also helps in reducing wastes as you have to deal with wastes properly.
• Lowering the cost associated with manufacturing goods.
• Providing proper training to the staff so that they become efficient workers.
• Being consistent in delivering the results.

What are the different elements or levels in a QMS?

Manufacturing of goods is a big process that can be subdivided based on the category of work they do. QMS tries to implement the rules for each of these processes. These elements are-

• The policy of an organization and its quality meeting objectives
• Quality manual
• Procedures and instructions
• Managing data
• Internal process
• Quality analysis of the products

Introducing and implementing the QMS in your manufacturing process

The steps to implement QMS can be divided into 7 steps as follows-

• Designing the product according to standards
• Manufacturing the product
• Testing the product before release so that it meets quality standards
• Correcting the flaws of the product
• Improving the entire process for better efficiency

If you want to implement QMS for medical devices and need help then you can visit the Orcanos website. It will provide you with integrated solutions for implementing QMS easily. For more information about please, visit https://www.orcanos.com/compliance/

Requirements management tool for medical devices

A company involved in the manufacturing and design of medical devices has to spend a lot of time on research in design and development. Companies spend millions of dollars and manpower just to design the framework of the manufacturing process and making guidelines for the safety of the device.

What is the need for a requirement management tool?

If the fault or an error is found in the device it can lead to a recall of the device. This will hamper the reputation of the company manufacturing the device. The sale of its medical equipment may fall and clients may retract their orders.

If the lives of the patient are at stake due to any technical glitch then the situation is even worse. This could also lead to fines by regulating bodies and your company may even lose license for manufacturing medical devices.

How can a requirement management tool help the manufacturing industries?

The use of a requirement management tool is to help the device manufacturing and designing team in three parameters.

Finding our the requirement of a medical device

This is important to start the design process. A medical device should be manufactured to help surgical and operating procedures and save lives. This is done to ease the workload of the medical personnel as well.

Mitigate risk

It is done to mitigate risk especially the mishaps and unfortunate events. If the lives of patients are compromised due to faulty equipment then you have to face lawsuits in the court rater than designing medical devices.

Do case-wise testing

The testing phase will enable the experts to find out all the cases and possibilities while doing the testing. Emphasis is given to all the operating procedures of the equipment based on certain conditions.   

What are the things that you have to consider choosing a best requirement management tools?

Finding out traceability

Traceability is a term that increases the efficiency, and risk in designing and manufacturing procedures. It is an important parameter that helps you to focus on the functionalities of your medical device.

Will the tool help you to identify the risks

Risk management is very important both in the design process and when it is being used in medical institutions such as hospitals and pathology centers. It helps you to find out the design flaws or loopholes in the device that may cause an accident.

Ease of use

It is very important to look at how easy it is to use your requirements management tools. As it will be used by the design and development tool you have to ensure that all your staff knows how to use the tool to adopt safer practices.

Are you searching for the right tool? Then visit Orcanos website because they have the right tool for all types of medical devices manufacturing industries. For more information about please, visit https://www.orcanos.com/compliance/  

Complete Automation of CAPA Process in Orcanos QMS

The Corrective and Preventive Action also referred to as CAPA is a very important integral part of any quality management system for pharmaceutical industries. Having an effective CAPA ensures that your company or organization is constantly working towards reducing the failures in the production, weakness, or testing of drugs and digging deeper for investigating the root causes and problems and then learning and improving them from these causes. The corrective and preventive actions empower the organization to correct the existing nonconformity of product and quality issues and then preventing the occurrence of the problem. If the FDA auditor is not satisfied with your quality management system (QMS) to manage CAPA then as an organization owner, it may cost you with a penalty and you may receive a warning letter.

The perception about CAPA differs from company to company; some think CAPA as some kind of task given to them to complete in order to stay compliant, while others look at CAPA as a number based metric that needs to be reduced immediately. But you need to know that CAPA is actually used to effectively manage the complete lifecycle and in simple words, it is also defined as a system which provides the tools for the complete evaluation, identification and investigation of a deviation. CAPA empowers quality management system (QMS) to be self-correcting and the tools are used to determine, implement and check the effectiveness of a resolution.

Today, most of the companies using a manual paper-based system for managing CAPA and this are the reason; all those companies are facing complexities such as:

• Poor communication
• Poor CAPA reporting
• Unsecure system and error-prone
• Lack of CAPA oversight
• Consume cost, efforts and time

Orcanos is the only reputable company that provides CAPA automation software which is specially designed after experiencing the industry-wide requirements to effectively manage the process. And this software is also used to integrate it with another quality process for attaining compliance. Orcanos CAPA automation software solution helps an organization to get complete automation of CAPA process in Orcanos QMS System and also make sure that all measures are identified to solve the issues and also ensures that the complaint related to quality is taken care of. It also provides a single unified platform for electronically evaluate, identify, analyze and investigate the incidents and also helps to make sure that similar types of errors are not repeated.

Orcanos CAPA management system as part of Orcanos Quality Management System (QMS) ensure all the regulation compliance, while completely automating CAPA process from the beginning stage to investigation and closure. Our Orcanos CAPA system is fully integrated with Orcanos electronic quality management system (e-QMS) to support medical device compliance. To know more details about Orcanos please visit our website here: https://www.orcanos.com/compliance/

ISO Standards 101 - Understanding the basics of ISO Quality Management Systems

There are more than enough ISO standards to confuse any organization that's looking forward to getting certified. Today, there is more than 16,000 point of compliance being used by certifying bodies to assess, monitor and audit any organization seeking to improve its quality management system. Here is a brief explanation of what these standards are and their specific usages:

ISO Standards

ISO9000 compliance contains the metrics or specifications required in order to attain the guidelines or criteria specified under that series. These standards referred to as the in order to group the compliance guidelines used for quality management and assurance. An International Standards Organization is identified as the series and its version. For example - the ISO9000:  family of quality management.

ISO 9000: This is a very popular standard, starting from ISO9001 to ISO9999. The ISO 9000 family of standards deals mainly with the use of quality management systems to make sure that the customers and clients of an organization have their needs met. Over one million organizations are ISO 9000 certified worldwide, making it one among the foremost used standards created by the international organization of Standardization. When organizations are ISO 9000 certified, they're telling their customers that they want to deliver quality products and services to them, also as communicating that they have plans in place to ensure that quality is always managed and is one of the organization's biggest concerns.

The International Organization for Standardization (ISO) was established with the purpose to ensure and supervise the quality of products and services, which created the Quality Management System (QMS) standards in 1987.  According to these standards, there are certain basic principles for quality management, which are-Customer Focus, the involvement of individuals, evidence-based decision making, and relationship management.

In the year 2005, the company named Orcanos Software comes into existence by Zohar Peretz and Rami Azulay. The only company that has integrated software for ALM (Design Control) and quality management (QMS). ORCANOS CAPA (Corrective Action and Preventive Action), as part of Orcanos QMS, ensure regulations compliance, while automating the CAPA process completely, from initiation to investigation to its closure. The thing which makes us unique from others is our years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers and other advanced corporations and assisting them in building their operational excellence.

Which ISO standard is right for your company?

The choice of ISO standard your organization will apply for will depend on the kind of company you have, the nature of its business, its production or manufacturing processes, the type of products and/or services involved and the quality management system you want to achieve.

To know or for more information about Orcanos or more please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

How Do Businesses Benefit From Implementing A Requirements Gathering – Traceability?

As a business owner, you may already know that successfully establishing the technical requirements is a part of developing, designing and testing of a new software system. In some cases, it is important to change the requirements multiple numbers of times along the way to meet each and everyone’s needs. When implementing a new system, it is essential for your company or organisation to allocate resources as efficiently as possible and estimate the complete impact the changes will have. Requirements traceability helps to control the time involved in the implementation of a new system, project's cost and the overall quality of the final outcome.

What Is Requirements Traceability? 

The term “traceability” is used by many organisations or Industries related to the field of supply chain management where the ability to accurately track changes and the transparency of processes is essential. In SDLC i.e. Software Development Life Cycle, requirements traceability refers to the traceability of requirements throughout the application development process which ensures that the delivered software fulfils all the necessary requirements and therefore it helps in preventing failures. This is the reason, traceability is considered as a very important key stipulation of efficient software requirements management.

Requirements Gathering – Traceability is an important element in the application development process as it greatly helps to locate and fix bugs in the software thus minimizing project failures. Following are the two main areas where traceability of requirements provides benefits which includes:

1. Requirements traceability provides context for the development team and it also defines testing team expectations to help specification and implementation.
2. The traceability of requirements helps ensure the development team is not only building the project accurately but they are also building the right product.

Why Should I Use Orcanos Requirements Traceability Tools?

Orcanos is the well-established and one of the leading company in providing the best traceability tool as part of the Orcanos ALM- requirement management tool. Orcanos Traceability tool is designed in such a way which is simple yet powerful for traceability matrix management between any kind of quality management system and application lifecycle management artefact, such as FMEA risk items, requirements, test cases, CAPA, customer complaints and many more. Orcanos requirements management traceability tool helps in managing your project’s requirements and other issues all in one fully integrated environment with traceability throughout the entire product development life cycle. Following are some of the benefits of Orcanos traceability management tool which includes:

• A simple tool for generating traceability matrix reports.
• Generate traceability matrix, impact analysis and inconsistencies alerts.
• Easy navigation between traced items, top-down and bottom-up.

Therefore, if you’re looking for the best requirements management tool for multilevel traceability matrix and impact analysis then opting for Orcanos is the right option. To know more information and details about Orcanos please visit our website here: https://www.orcanos.com/

Benefits And The Importance of Documentation in Quality Management Systems

In today’s modern world, having quality documentation is very important. One of the most essential parts of running any successful business or organisation is to make sure that you always have clear, precise and quality documentation of each and every single crucial transaction, process and action that takes place. A well designed and well implemented documented system offers many advantages as it minimises the potential for error, reduces downtime when deviations occur, ensures that quality standards are met and most importantly it allows for easy monitoring of processes, so that process outputs are analysed and appropriate adjustments are made properly. A quality management system(QMS) is one such formalized system that documents processes, responsibilities and procedures for successfully achieving quality policies and objectives and it constantly strives to deliver a quality product or service to the customers.

The Importance of Documentation in Quality Management Systems    

If you want your organisation's activities to meet regulatory requirements, customer satisfaction and continually improve its efficiency and effectiveness then having a good quality management system helps to co-ordinate and direct an organisation's activities. But it is important to ensure that the QMS documentation must succinctly and accurately document your business or organisation’s procedures, processes, structure and resources. So, it is important to make sure that you choose a quality management system like Orcanos QMS which helps to keep all your important data and information required in order to control the quality processes all in a single point of access.

Orcanos is the most reputable company that have many years of experience providing integrated software for quality management systems (QMS), ALM design control, specialises in the medical device industry, combined with meeting the regulations compliance. Orcanos quality management system documentation fulfils many functions such as clear communication of information, sharing knowledge and providing evidence of conformity. One thing that makes Orcanos unique and stands out from others is that we have many years of working experience in a regulated Hi-Tech industry working with hundreds of medical device manufacturers and other companies by assisting and helping them in building their operational excellence.

Good documentation in the quality management system will greatly improve your organisation’s efficiency and effectiveness by ensuring that your quality management system has a strong foundation. By considering the above factors, it is clearly evident that good documentation is very important to a functioning quality management system. No matter whether you are a start-up company or an organisation, Orcanos QMS ensure that each and every process is understood and consistently executed by employees and helps your company or organisation achieve fit for purpose QMS documentation. Therefore, ensuring your quality management system delivers a quality product and services to your customers. To know more information and details about Orcanos please visit our website here: https://www.orcanos.com/

Why Is It Important To Have ISO 9001 Quality Management Systems?

As a team management member, have you ever tried to convince your senior team members that implementing a good idea for your business is worth the cost? It is really easy to sell if you can show that spending $100 will give you a profit of $1000, but for a good idea like implementing a Quality Management System (QMS) based on certified ISO 9001 requirements, the comparison is not that easy as we think. It is nearly impossible to define a specific dollar amount for your return on investment, so this is why you need to focus and understand on the benefits of implementing ISO 9001 Quality Management System (QMS). After implementation, you can easily start to identify where your company or organisation can gain improvement and what profit value they will have.

What Is ISO 9001 Quality Management Systems?

ISO 9001 is an international standard that specifies requirements and dedicated to the quality management system. Today, many organisations are using this International standard to demonstrate the ability to consistently provide products and services that meet all the regulatory requirements and customer needs. One of the main benefits of being ISO 9001 certified is that it will improve your level of customer satisfaction and will help and support your staff. If your company is in the field of food manufacturing then being ISO 9001 certified is very important because of its risk-based standardization and control measures from the QMS.

No matter whether you’re a small, medium or large-sized manufacturer, having a good quality management system like Orcanos ISO 9001 Quality Management Systems allows you to monitor irregularities for safety food standards and enforces an industry-wide higher degree of quality. Your company will have an efficient management process in place to monitor the entire production process and it also gives the opportunity for continuous improvement. Orcanos is the leading provider of the latest version of ISO 9001 quality management system which helps to keep the entire data or information required in order to control the quality process all in a single point of access. Orcanos ISO 9001 QMS enables companies or organisations to greatly eliminate paper best quality processes while adhering to strict ISO quality standards and MDR/FDA regulations.

Having Orcanos quality management system means employees in your organisation are motivated to implement quality processes and it helps to boost overall productivity and staff performance. One of the key components of Orcanos ISO 9001 is having overall business processes and it also gives the ability to define responsibilities for quality control and relaying those specifications to your employees. Therefore, if you’re looking for ISO 9001 certified QMS then opting for Orcanos is the right option. For more details and information about Orcanos please visit our website here: https://www.orcanos.com/compliance/

The Benefits of Using Document Control Software in Your Business

Every business looks for ways to save costs and increase the productivity of their processes and their employees. Since time is of the essence to every organization, it is critical to identify the ways of increasing efficiency as early in the life cycle of business as possible. With the advancements in the field of technology, there are various ways of achieving these goals. One of these ways is in using an Electronic Document Management System Software, through which business productivity can be enhanced and savings can be realized. Document control software is defined as a computer system that is used to store and track electronic documents or images of paper documents.

The Benefits of Using Document Control Software in Your Business

Document control software brings a lot of benefits that come in both tangible and intangible ways. One of the most practical benefits of this is reduced storage. Storing paper-based documents require space which can often occupy a huge area in your workplace. Aside from storing files, sorting and reviewing such documents can also mean too much labor work. What the software does is keep everything in paperless documents and integrate it into one management system. Paper-based storage can also pose serious problems concerning retrieval. It is time-consuming and may require too much manpower especially in large operations. With a document control software, you can always minimize the time spent in retrieving files. You can do it right under your fingertips without even shedding a single sweat! You can also process and access documents using document control software without leaving your desk. This gives you more time to accomplish other things while keeping track of your documents and records.

Document control software not only saves time but also ensures a great deal of efficiency. Avail the benefits of this automated system of document control with the company named Orcanos. In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The only company that gives integrated software for quality management (QMS), and ALM (Design Control) combined with regulations compliance and focuses on the Medical Device industry. Our FMEA risk management system software is designed in such a way to reduce and manage risks in a more effective way. With many years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers makes Orcanos unique from others.

The ultimate goal in the pharmaceutical industry is to provide quality products and services that will eliminate diseases while at the same time ensure the safety of the patients. Therefore, with the incorporation of quality risk management, a lot of failures can be overcome, threats can be minimized, or their impact reduced.

For more details and other information to know about Orcanos please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

Importance of Having Application Performance Management - Better Business Insight

As an organization owner, how do you know when a real-time problem exist or going to arise with your application? How can you have a proactive view of your software? Is it possible to identify where the actual problem exists in a complex and diverse IT landscape? How do you know what exact code is causing the havoc or where are the bottlenecks? If you want to know the answers for all the above-mentioned problems then having Application Performance Management (APM) is the best solution. The main purpose of application performance management is to provide you with all the answers to such problems and it also provides the best insights and information you need to efficiently manage your application performance.

What Is Application Performance Management? 

Application Performance Management (APM) is the process of discovering that a problem exists and figuring out where and what the actual problem is and lastly solving the issue thanks to application troubleshooting. Which means being alerted to application downtime by isolating the root cause of the actual issue and then tuning the right code to solve the issue. In other words, the application performance management starts with monitoring and application monitoring is the basis of the application management system.

Application Performance Management - Better Business Insight          

The main key feature of application performance management is to keep the users happy and productive. Satisfactory user experience is the main focus of application performance management endeavours. Today, in the APM software market, Orcanos is one such company which has always stood out for its user-centric resolutely approach as well as for providing the quality of the assistance. Orcanos Application Lifecycle Management Tool and services greatly contribute to APM and are based on end-user monitoring. The main aim of Application Performance Management is to provide Better Business Insight and improve user satisfaction, user experience and user productivity. One of the most basic features of Orcanos APM software is to track the performance of all the transactions generated by your application. This analytics data present in your APM tool helps you to understand what all requests are frequently accessed, which application needs improvement and are running slow.

Businesses that are using Orcanos application performance management software tools consider this software as their edge over competition since it helps them to solve issues faster, it helps to have better business insight over their operations and resolve a greater number of problems over a certain period of time. If your company or organisation rely on applications then application performance management is an invaluable software for you. And if you are from the development team then it is 100% yes and APM is the right choice for you.For more information and other details about Orcanos please visit our website here: https://www.orcanos.com/compliance/

Risk Management Widely Used Methods And Techniques

Do you think your business involves many risks and uncertainties? Maybe you are right. But, the truth is almost all businesses in the world have risks and uncertainties. And their impact is very significant and no one can overlook it.

A risk is an event that will affect the overall business objectives of an enterprise. It should be viewed as an opportunity rather than a threat that each enterprise should try to foresee so that the consequences of the events can be optimized. Sometimes, risks make the organization more alert, active, and responsible to create value for shareholders. If an organization is in a position to properly define risks and articulate them, then most of the objectives are achieved.

The function of risk management is to organize and carry out a plan to manage or reduce the risks to which a firm is exposed. This planning involves a five-step process. The first step is to identify potential risks. The method of identifying risks may depend upon the organizational culture, industry practice and compliance. Once risks are identified, the next step is to assess the potential severity of loss and probability of occurrence. The third step is to search out a potential treatment for the problem. This may involve the transfer, avoidance, reduction or retention of a possible risk. Next is to implement the plan by choosing the best method of treatment. Before implementation, a review and evaluation of the plan are important.

One of the widely used Risk Management methods and techniques today is the FMEA. Failure Mode and Effects Analysis or FMEA an analysis technique that facilitates the identification of potential problems in a design or process by examining the consequences of lower-level failures. This is generally used in product development as well as in operations management. This aids the managers in determining the potential failure manners that a system might give through the classification of the likelihood and the severity of such errors.

For the best Risk management tool, the company named Orcanos in the year 2005 comes into existence by Zohar Peretz and Rami Azulay. The only company that gives integrated software for quality management (QMS), and ALM Tools (Design Control) combined with regulations compliance and focuses on the Medical Device industry. Our FMEA Risk Management system software is designed in such a way to reduce and manage risks in a more effective way. With years of experience in a regulated hi-tech industry, operating with medical device manufacturers makes the Orcanos unique from others.

The ultimate goal in the pharmaceutical industry is to provide quality products and services that will eliminate diseases while at the same time ensure the safety of the patients. Therefore, by using a quality risk management tool, a lot of failures can be overcome, threats can be minimized, and their impact can be reduced.

To know or for more information about the Orcanos or more please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/