Understanding 21 CFR part 11 regulations

21 CFR part 11 is an FDA regulation that requires companies to track and record and therefore be accountable for retaining electronic records within their software and systems.

Users of our image analysis software practicing GxP may require a compliant version where access is tracked and recorded in a secure environment. Talk to us about ensuring your compliance with 21 CFR part 11 and EU Annex 11, whilst using our software.

21 CFR part 11 compliance checklist

The regulation is made up of a number of parts:

• Audit trails (21 CFR 11.10(e))
• Limit system access (21 CFR 11.10(d))
• Electronic signatures (21 CFR 11, Subpart B)
• Password restrictions (21 CFR 11, 11.200 (a))
• Emergency logins (21 CFR 11, 11.200 (3))
• Version History (21 CFR 11, 11.10 (k))

Below we address how our GxP Module software can ensure compliance in key areas.

How to maintain GxP electronic signature compliance

As part of the FDA’s 21 CFR part 11 regulation organisations are required to show the authenticity of electronic records. Our GxP Module enables you to comply with these requirements.

It does this by generating a two-factor authentication for approvals and sign in, as required by the FDA. It also offers the following features to keep you compliant:

• Enables data integrity and authenticity of results with administrative privileges assigned to each electronic signature
• Provides emergency access
• Provides the ability to create secure and unique IDs, with the option to have password expiry dates

Our GxP Module eliminates project overwriting through our check-in / check-out system. This means that analysts can collaborate on a project, without risk of overwriting each other’s contributions, leading to a streamlined and easy to use process.

Maintain data integrity with comprehensive electronic reports

Our GxP Module provides the ability to comply with the regulations describing audit trails – 21 CFR part 11.10(e).

Our solution provides an easy-to-read, time-stamped audit trail which contains a complete history of projects created, retrieved and approved.

With our full analysis audit trail / report you can easily reproduce analysis, including all analysis interventions.

The solution also comes equipped with an access log. This automatically tracks critical signature and system access actions such as:

• Changes to user privileges
• Login fails
• Emergency logins
• The action of changing logins

All of this information is held to hand, so if called upon you can easily demonstrate your compliance through electronic reports.

Maintaining compliance with the Electronic Code of Federal Regulations.

21 CFR part 11.10(d) refers specifically to secure sign-ins and limiting system access to only authorised individuals. This includes controlling who can use the system, sign off a project and view and alter a record.

Our compliant system has the following features to enable users to meet compliance:

• GxP Module can detect and record unauthorised attempts to gain access to the system
• It only allows access to authorised individuals who have a valid username and password
• Based on a state of actions (operational checks) and user permissions (authority checks) certain actions or sequences can be automatically disabled to maintain the integrity of the system
• For audit and security purposes, all electronic signatures remain permanently associated with the electronic records, including date, time and reason for approval.

Installation Qualification and Operational Qualification (IQOQ)

In addition to supplying versions of our image analysis software compliant with 21 CFR Part 11, we also offer comprehensive Installation and Operational Qualification packages which ensure the software has been installed correctly and is operating compliantly at customer sites.

These can be performed virtually (using software like Microsoft Teams, Zoom and Teamviewer) or in-person on-site. Upon completion of the IQOQ, the customer will be issued with a full suite of documentation to support 21 CFR part 11 compliance including a certificate to verify that we have witnessed the software being operated correctly on-site.

Please enquire to learn more about our IQOQ packages, ideal for peace of mind within the biopharma industry.

Are you ready to ensure 21 CFR part 11 compliance?

Our team has supported a number of organisations in ensuring their systems are set up correctly to track and store the required information, and that the right processes are in place for compliance with 21 CFR part 11 regulations.