The Manufacturer’s Guide to 21 CFR Part 11 Compliance

Life sciences manufacturers are required to comply with strict guidelines outlined by regulatory bodies including the US Food and Drug Administration (FDA). After all, pharmaceutical products and medical devices have a direct impact on the health and safety of the end consumer.

As part of a broader code of regulations to govern the life sciences industry, the FDA instituted 21 CFR Part 11. This regulation applies to both medical device and pharmaceutical manufacturers with the primary objective of governing the handling of electronic records and electronic signatures.

In this post, we’ll review the regulations outlined in 21 CFR Part 11 and how manufacturers in the life sciences industry can simplify compliance as they undergo their digital transformation.

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21 CFR Part 11 refers to part 11 of Title 21 of the Code of Federal Regulations as stipulated by the US Food and Drug Administration. These regulations focus on electronic records (including electronic batch records and device history records) as well as electronic signatures, providing conditions under which these particular compliance activities can be trusted to the same degree as signatures on paper documents.

Part 11 of this code of regulations guides manufacturers on the integrity and confidentiality of electronic data and documents and provides an environment where the parties involved can’t contest approval and review of electronic signatures.

Apart from electronic documents, this code also encompasses images, sound files, source code, and videos. Ultimately, 21 CFR Part 11 enables manufacturers in the life sciences industry to sidestep most of the more complex paper document management.

Notably, the comprehensive nature of this code lends itself well to a manufacturer’s quality management system. It ensures that all electronic material stemming from manufacturing practices meets the standards and regulations required by the FDA.

Life sciences manufacturers have a set of requirements from the FDA detailing essential quality management considerations when implementing digital document management systems. These include:

Data integrity: Businesses need to have digital processes to authenticate their data and ensure its integrity. This allows businesses to have confidence in their data, ensuring that whatever they generate, store, and share is accurate and authentic.

Retrieval: Part 11 instructs life sciences manufacturers to implement secure methods for protecting and controlling data during its generation. This allows manufacturers easy access to data through indexing and archiving, simplifying internal and external audit processes.

Validation: The FDA mandates manufacturers to ensure that their systems are accurate, reliable, and perform consistently as intended. Manufacturers should detail the workings of their system, showing how the elements function to get the required result.

Therefore, manufacturers should also add the results from the validation tests, proving the system's robustness.

Audit trails: 21 CFR Part 11 instructs manufacturers to keep a consistent and comprehensive history of their various documents. This gives auditors and regulatory bodies the entire document history, detailing the multiple version corrections and updates, including dates and responsible personnel.

Operational controls: Through part 11, the FDA stipulates that manufacturers use operational system checks to enforce the permitted sequencing of steps and events as appropriate.

In other words, manufacturers should use quality monitoring solutions that help track and control procedures as recommended by the regulator. For instance, document control can follow a phase-gate approach, entailing authoring, review, and approval of documents by relevant personnel.

Security controls: Life sciences manufacturers must ensure that only authorized individuals can access documents and the document management system. Furthermore, said individuals require unique login identifiers and passwords to record their access, ensuring that only relevant parties have access to secure information.

Digital signatures: Finally, each individual has an electronic signature for more effective and less complicated efforts of tracking and ensuring accountability. For this reason, a digital signature should contain the author's name, the date signed, and the reason for authoring the document. E-signatures help streamline compliance procedures by reducing friction and enable manufacturers to generate a digital audit trail that is easy for auditors to follow.

With the earlier discussed requirements, medical manufacturers can create CFR part 11 compliance checklists to maintain the security and integrity of their digital documents. However, this can be challenging, especially when the company moves from paper to digital.

Here’s how such manufacturers can effectively venture into digital compliance:

• The digital compliance tool should have security features for proper user identification, access, and system privileges. Simply, the digital solution should allow manufacturers to assign unique usernames and passwords. This promotes document integrity and system security.

• The digital solution should have the ability to provide e-signatures for authorized personnel. Additionally, the owner should certify this signature, making it legally binding similar to hand-written paper signatures.

• An ideal digital compliance solution should provide ordered historical data, making it easy to audit the system. The audit trail provides a comprehensive account of documents, their authors, date of authorship, and any amendments.

As manufacturers in regulated industries continue to shift away from traditional, paper-based solutions within their business, it’s imperative that they address rules and regulations outlined by regulatory agencies such as 21 CFR Part 11.

We’ve worked with a number of pharmaceutical and medical device manufacturers to help digitize compliance procedures with Tulip’s Frontline Operations Platform, ensuring that businesses are able to consistently and securely track and store critical production data, creating a digital audit trail that can stand up to scrutiny from regulators.

If you’re interested in learning how you can improve your operations with an integrated, digital solution while maintaining compliance as a core pillar of your business, we invite you to reach out to a member of our team to learn more about how Tulip's Frontline Operations Platform!