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What is 21 CFR Part 11?

Title 21 CFR Part 11 is the portion of the Code of Federal Regulations that provides standards determined by the Food and Drug Administration (FDA) on electronic records and electronic signatures. With electronic records widely used in the Life Sciences industry, most companies will find FDA 21 CFR Part 11 applicable. 

Part 11 helps companies safely maintain data securely so that it is not lost or corrupted, ensures companies are implementing systems and software correctly, makes sure there are data trace changes, and prevents falsified records. 

What is Annex 11?

Annex 11 is a European Union (EU) Good Manufacturing Practice (GMP) for the quality and compliance of computerized data systems that manufacture pharmaceuticals and medical devices. Annex 11 applies to all systems used where GMP regulations apply; when automated systems replace manual operations, there should be no resultant decrease in product quality, process control or quality assurance, and no process-related risks.

Who must comply with 21 CFR part 11 and Annex 11?

Regulated companies with documents or records in electronic format must comply with FDA 21 CFR part 11. Part 11 pertains to pharmaceutical companies, manufacturers of medical devices, biotechnology companies, CROs, biologics developers, and other companies regulated by the FDA. Companies that comply with Annex 11 manufacture products made or sold in the European Union to address the increasingly digital environment in which electronic programming can replace human judgment. 

How does 21 CFR part 11 and Annex 11 apply to your company?

Even if your Life Sciences company relies on paper records, as soon as you upload a document to a server, your company must comply with 21 CFR Part 11 and Annex 11. Under FDA regulations, 21 CFR part 11 applies to electronic records used as a digital representation of information that is maintained, created, modified, archived, distributed or retrieved by a computer system. Even if your company relies on a paper system, validation is needed to confirm that the electronic copies match the paper records. Annex 11 applies to all software, hardware, risk management and personnel implemented in the manufacturing process. 

How to become 21 CFR Part 11/Annex 11 compliant?

Annex 11 compliance includes computerized systems, electronic forms and signatures, validation of the IT infrastructure, a system risk assessment, and set restrictions for data security. To support 21 CFR Part 11 compliance, data security measures like password standards should be in place to ensure the appropriate people have permissions to sensitive data. Clear audit trails should demonstrate creation, modification, or deletion to show traceability to the FDA. Implement 21 CFR part 11 and Annex 11 guidelines on electronic signatures and ensure regulatory agencies are aware of their use. Validate installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) to ensure software compliance. 

Always remember that FDA 21 CFR part 11 and Annex 11 compliance are always the responsibility of Life Sciences companies, not the software platform. 

Why Arbour Group for 21 CFR Part 11 and Annex 11 Compliance 

Arbour Group 21 CFR Part 11 and Annex 11 compliance checklist assessment and remediation services help clients ensure that electronic records and electronic signatures are trustworthy, reliable, generally equivalent substitutes for paper records and traditional handwritten signatures. Ensure that functions are in conformance with the requirements of 21 CFR Part 11/Annex 11 compliance.

Arbour Group's extensively trained professionals evaluate a client's use and documentation of electronic records and electronic signatures as governed by applicable regulatory requirements. The result of a compliance checklist and assessment determines the effectiveness of a client's process within a highly regulated environment and suggests appropriate remedial actions as necessary.

21 CFR Part 11/Annex 11 Compliance focus on six critical areas:

  • Impact of regulations on the client's computer systems, including Quality Management Systems 
  • Identification of the client's computer systems and operating environment
  • Hosting and interpretation of user interviews
  • Review and consideration of client procedures
  • Analysis of procedural documentation, validation and audit data
  • Regulatory significance of the computer systems

Arbour Group can give our client's an unmatched, in-depth and thorough inspection of their systems and procedures. We ensure compliance with regulatory requirements through our years of experience and unique solutions to companies in the Life Sciences. 

The Arbour Advantage

Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.