CFR 21 Part 11 Guidelines Explained - Industrial Physics CFR 21 Part 11 Guidelines Explained - Industrial Physics

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CFR 21 Part 11 Guidelines Explained

CFR 21 part 11 guidelines: How to check for compliance


CFR 21 Part 11 is a set of guidelines used throughout the medical industry to regulate electronic records and electronic signatures (ERES). It is used by all kinds of medical device manufacturers, biotech companies, biologics developers, drug manufactures and medical packaging suppliers, and it also relates to data protection as well as the digital trail of a specific product or item.

What is CFR 21 Part 11?

Title 21 is the part of the United States’ Code of Federal Regulations that establishes the Food and Drug Administration (FDA). Part 11 sets out the criteria for creating electronic records and electronic signatures that are trustworthy, reliable, and equivalent to paper records.
It can be looked at as the digital equivalent of a paper trail when it comes to packaging for drugs or medical devices and Part 11 outlines the ways electronic records in a medical device company’s quality management system should be administered.

How to comply with Part 11 guidelines

As electronic records are now used throughout the majority of medical device companies and related packaging manufacturers, the guidelines apply to most. Even if your company has a paper-based system and the second data is uploaded to a server, it needs to come in line with CFR 21 Part 11 regulations. The areas that need attention to comply with Part 11 include:

1. Establish clear audit trails

To make sure you have a clear progression throughout the entire testing cycle of a product, high quality audit trails are necessary. This means you need computer-generated, time-stamped audit trails that are completely secure, so you can independently record the date and time of operator entries and actions around your electronic records.

2. Electronic signatures

Part 11 sets out a series of regulations for electronic signatures designed to make it incredibly hard for a signature to be falsified. The easiest way to do this is to use an electronic Document Management System (eDMS) that allows you to create an evolving audit trail that can’t be edited.

3. Ensure your system is validated

The quality management system you use for logging and testing your products must be validated so that you know its performance is as accurate, reliable, and consistent as it should be. Operational checks are also key, as they can help you set up automated approvals and signatures that make it possible to gain control and oversight of the entire process. The access and editing rights within your system should also be created with security in mind.

4. Data integrity and retrieval

It is essential that the data you collect is kept to the highest possible standards of authenticity, integrity, and, when appropriate, confidentiality. It should also be easy for you to access this data when needed. Ideally, this means storing records so that they are automatically archived and indexed in a way that is simple to retrieve.

How to ensure your testing data is Part 11 compliant

Choosing testing solutions that are designed to meet the standards laid out in Part 11 is the first step. Products like the BT Integra Pack  and The Smart TME WORKER Integra can fit into an established 21 CFR Part 11 compliant environment and meet the Electronic Record requirements of operator authorization, data integrity and data retention.
With more than 100 years’ experience, we’re able to provide trusted and personalized solutions that are fully informed by current standards and guidelines. For help ensuring that your QA process for medical products and packaging will provide data that will easily integrate with your electronic record keeping system, get in touch with our experts.