HomePolarionPolarion ALM Software | How to ease FDA 21 CFR Part 11 Compliance with Polarion Software?

Polarion ALM Software | How to ease FDA 21 CFR Part 11 Compliance with Polarion Software?

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Article Context:

  1. 21 CFR Part 11 Compliance
  2. 21 CFR Part 11 for Records and Electronic Signatures
  3. IQ,OQ and PQ Validation
  4. 21 CFR Part 11 QMS Compliance

There may be some misunderstanding surrounding FDA 21 CFR Part 11 when it comes to regulatory compliance for manufacturers of medical devices.

We have discovered a major pitfall here: Many businesses mistakenly believe they comply with the regulations but that is Not True (frequently because of misinterpreting the rules).

The FDA's guidance on electronic records and electronic signatures is included in 21 CFR Part 11. It provides direction for industry best practices and describes how to handle electronic records in a medical device company's quality management system. The process discussed below will help you to understand and how to ease FDA 21 CFR Part 11 Compliance with Polarion ALM software.

Verify whether 21 CFR Part 11 compliance applies to your business

Businesses who refuse to adopt 21 CFR Part 11 frequently claim that their "master records" are still on paper, even though they upload documents to a shared file or another publicly accessible location on a server. They mistakenly believe that "paper-based" records negate the necessity for Part 11 compliance.

To begin with, the term "master records" is often misused. Some will claim that the paper is their "master record" and believe that as long as it is preserved, it does not matter what they do afterwards (such as scanning and uploading). In actuality, the business is obligated to comply with the regulations as soon as the document is posted to a server. Polarion ALM can help you with this process in a proper way.

For password protection and data security, adhere to Part 11's instructions

A significant component of 21 CFR Part 11 is data security. Proper responsibilities and permissions are required for all the users having access. This is true whether you have a straightforward folder tree structure or a high-quality system solution like Compliance Group. If you decide to use folder trees, keep in mind that they can be laborious.

You need to check permissions in each folder. It is a major deal for compliance because you will need to extract key resources from IT to check it all.

Passwords play a significant role in digital security. How will you get on the network? The biggest issue with 21 CFR Part 11 is security since you have to make sure that the correct people have the right permissions and that not just anyone can enter. Polarion software is a great option for this.

Provide distinct audit trails for traceability

To be able to track back when and which user performed a given action, clear audit trails are necessary. When were records generated, changed, removed, or rendered unnecessary?

Every event needs to be documented with a precise username, time, and date. The validated and completely traceable platform of Compliance Group records this user information with each action performed in the programme and enables authorised users to refer and streamline activity audit trails.

Observe the requirements of 21 CFR Part 11 for records and electronic signatures

There are several ways to adhere to the requirements of 21 CFR Part 11 for examining and approving information:

  • Biometric data, such as a fingerprint scan or retinal scan
  • Electronic or Digital signatures
  • Scanning
  • Using software to record handwriting

We employ electronic signatures, which provide signers with special accounts and passwords. There are no permitted generic department usernames. Usernames should be associated with a single person, not a group, to maintain openness. Polarion ALM software can manage to do this.

Do not delegate control over 21 CFR Part 11 compliance

Software platforms are increasingly claiming that they can handle every aspect of your 21 CFR Part 11 compliance. In the end, this is untrue because the medical device company is ALWAYS responsible for Part 11 compliance. A software company should not claim to have managed everything because your business is still responsible for it.

Validate IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) scores

The cloud-based service offers executable IQ templates that guide you through the process of qualifying your operating system, browser, network connection, and display resolution. Additionally, we supply pre-executed OQ, PQ protocols to save your production files and provide necessary training to you and your team on these subjects. Computer system validation FDA is needed if you want to handle this process in the best way possible.

While selecting a QMS solution, take 21 CFR Part 11 electronic records compliance into account

As compliance is a continuous process, you must make sure to manage electronic documents and signatures properly during the whole lifecycle of your project.

The QMS you choose will be crucial to Part 11 compliance. You must account for the possibility that your QMS may not be in compliance with CFR Part 11 or may not include pre-validated templates in your business strategy. To achieve compliance, general-purpose solutions will need extensive configuration, staff training, validation testing, and possibly outside assistance.

These are the reasons why 21 CFR Part 11 non-compliance is never an option. You must read the article completely to understand several reasons why it is important. Computer software assurance is there in this process, and you can use Polarion ALM for that.

FAQ's

Can Polarion ALM be used for electronic signatures in FDA-regulated environments?

Electronic records and signatures can be utilized to replace paper records and handwritten signatures as outlined in FDA regulation 21 CFR Part 11. It is specifically applicable and is useful to Polarion clients working on development, deployment and production of medical devices, pharmaceuticals, and related research testing equipment. 

How does Polarion ALM ensure data integrity and security?

Teams may effortlessly collaborate on shared assets with Polarion in a secure setting. Granular authorization restrictions and flexible adjustable process automation let you manage who can view what, who can alter what, and when. 

Can Polarion ALM be validated for use in FDA-regulated environments?

Medical device businesses have the chance to benefit from the organizational advantages of paperless record-keeping systems thanks to 21 CFR Part 11. Additionally, it enables the FDA to make sure that document security and authenticity are properly preserved when medical device businesses employ electronic record-keeping systems.

What documentation and records are required for compliance with 21 CFR Part 11?

According to FDA 21 CFR Part 11 regulation, electronic records, and digital signatures both are treated the same as paper records as well as handwritten signatures. Companies subject to regulation that have any documents or records in electronic format are required to abide by the regulation. 

What is the role of users and administrators in maintaining compliance with 21 CFR Part 11?

Records in electronic form that are created, amended, maintained, archived, retrieved, or communicated by any record-keeping standards outlined in agency regulations are covered by 21 CFR Part 11.

Is Polarion ALM compliant with other regulations besides 21 CFR Part 11?

Besides 21 CFR Part 11, Polarion ALM is compliant with FDA 21 CFR Part 820. To achieve this compliance, you need to work on desperate digital information and mountains of paper records or invest in any other costly DMS. With Polarion ALM, you can ease this process and create a Document History File (DHF) including forensic level traceability in minutes and satisfy any audit.