21 CFR Part 11 is the FDA's regulations for electronic documentation and electronic signatures. This Electronic Records and Electronic Signatures regulation acts as the FDA's standard for considering electronic records and signature to be reliable.
Most companies seeking FDA approval opt for electronic submission to get products on the market sooner, making 21 CFR Part 11 relevant to any companies seeking FDA approvals, especially to life sciences companies trying to sell products and services in the United States. 21 CFR Part 11 is a complex regulation standard and these 5 tips will help to ensure your organization remain in compliance.
1. Data Security
Data security is critical for 21 CFR compliance. Providing multiple user roles and access levels with appropriate permissions will help ensure your data is secure and you are in compliance. Make sure to check permissions and ensure users have appropriate access for their role.
2. Password Protection
Passwords play a major role in digital security and 21 CFR compliance. Follow password best practices when creating them, including periodic password updates, automatic logging out of inactive users, and system lock outs for multiple failed password attempts
3. Audit Trails
Audit Trails must be established to track all electronic record modifications. It is your responsibility to track what user performed any modifications, along with the exact date and time the modifications were made. This includes record creation, modification, and deletion. You should also track when users accessed records even if no modifications were made
4. Electronic Signatures
If you are using electronic signatures, you must first notify the FDA. To comply with 21 CFR Part 11 guidelines, each person signing the document should have separate access to the document, and the documents should not be editable once in the approval process. If edits are needed the approval process should begin again one edits are made.
5. IQ/ OQ/ PQ Validation
IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) are all qualifications you need to validate to confirm 21 CFR Part 11 compliance. IQ validates that your software is installed correctly. OQ validates that your software is capable of meeting regulatory requirements. PQ validates that your browsers, operating systems, etc. comply with installation requirements. Establishing reporting and protocols will help you to maintain compliance.
RheoSense VROC initium one plus automated viscometer and m-VROC® viscometer software are both 21 CFR Part 11 compliant. The software provides different access levels for your users (standard user, IT admin, super admin etc.) and ensures data integrity, preventing users from potentially manipulating your data. Contact us to learn more about our 21 CFR Part 11 compliant software!
Written by: Eden Reid, RheoSense Senior Marketing and Sales Operations