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/