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/