21 CFR Part 11 is the Food and Drug Administration (FDA) regulation governing the use of electronic records and signatures in regulated industries. It outlines the criteria under which electronic records and signatures are considered equivalent to paper records and handwritten signatures. Essentially, it provides guidance on how to ensure the integrity, reliability, and security of electronic records and signatures, allowing regulated entities to leverage technology for efficiency and compliance.
Key aspects of 21 CFR Part 11
Scope
Applies to all electronic records and electronic signatures that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations.
Compliance
Requires the implementation of controls, including system validation, audit trails, electronic signature management, and personnel training, to ensure the accuracy, integrity, confidentiality, and availability of electronic records.
Purpose
To ensure the trustworthiness and reliability of electronic records and electronic signatures, enabling their use in place of paper records and handwritten signatures within FDA-regulated activities.
Assessment
Compliance is typically assessed through FDA inspections, internal audits, and ongoing monitoring of electronic systems and processes.
Who needs to comply?
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Any individual or organization subject to FDA regulations (e.g., pharmaceutical, medical device, biotechnology companies) that uses electronic records or electronic signatures.
Why is compliance important?
Failure to comply with Part 11 can result in regulatory actions, including warning letters, product recalls, import alerts, and legal penalties, potentially jeopardizing the ability to market and sell FDA-regulated products.​
myLaminin’s compliance with 21 CFR Part 11
myLaminin has undertaken a detailed self-assessment against the "ERES Assessment 0 - FDA 21 CFR Part 11 & PIC/s Annex 11; Health Canada GUI-0050". The purpose of this evaluation was to ensure that the myLaminin protocols for electronic records and electronic signatures (ERES) handling complies with the regulatory requirements outlined in:
FDA 21 CFR Part 11
This is a regulation by the U.S. Food and Drug Administration (FDA) that sets the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to FDA-regulated industries.
PIC/s Annex 11
This is a guideline from the Pharmaceutical Inspection Co-operation Scheme (PIC/S) focused on computerized systems used in GMP-regulated activities. It outlines requirements for the validation, maintenance, and security of these systems, including aspects related to electronic records and signatures.
Health Canada GUI-0050
This is a guidance document from Health Canada that adopts the PIC/S Annex 11 for application in Canada. It provides interpretation of GMP requirements related to computerized systems, including electronic records and electronic signatures, within the Canadian regulatory context.
Our self assessment indicates that myLaminin is between 80-90% compliant with this standard.
Items which fall under the Not Applicable (NA) or Not Supported categories are a result of some very granular requirements including:
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While our audit trail capabilities are robust and capture each action undertaken by any research team member on the research data repository, we do not currently capture the reason for that change or snapshots of prior versions of the data. We are evaluating the ability to support this capability but are concerned about system useability if this feature were to be enforced for all system transactions.
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myLaminin does not use biometric eSignatures or cards in support of identification or authentication protocols.