Your Guide to 21 CFR Part 11 Compliance

For life science companies, 21 CFR Part 11 compliance has always been a challenge. While using a cloud-based quality management system helps streamline compliance processes by allowing for digital signatures, organizations must be sure to tick all the boxes when it comes to complying with stringent FDA guidelines.

21 CFR Part 11 is an FDA guidance that sets out how organizations operating in the United States can use electronic records and digital signatures in their quality management systems to replace paper-based documents and “wet signatures”. Put simply, any organization that uses quality management and needs to conform to FDA regulations, such as pharmaceutical and life sciences organizations, should be aware of 21 CFR Part 11 and its requirements.

To cover your bases, improve your process, and make sure your life sciences organization is compliant, we recommend using our 21 CFR Part 11 compliance checklist:

With this checklist, you can identify any areas of risk, adhere to key components of compliance, and ensure you have all the right systems in place to achieve full compliance.

While operational processes within your quality program can be made much easier with automation, keeping track of the design, development, review and acknowledgment of your program policies and procedures can quickly become cumbersome. The critical features and functions of the software tools you can implement to facilitate this process can be broken down into 4 main stages:

• Validation
• Audit
• Records
• Retention

Completing the checklists for each of these categories is a great starting point for your evaluation of software and the capabilities that you would find most helpful in the implementation and validation of your Quality program processes.

At AODocs, we have used this checklist as a guide to providing a QMS application within our qualified platform to enable quality programs like yours. We also provide a path for enhancing your Quality program, with advanced learning and acknowledgements, information governance and records management, audit, corrective actions, and quality events. Each one of these can keep your QMS investment growing with your Quality program.

To learn more, download our complete checklist for the 4 stages of compliance:

If you’d like to learn more about how AODocs for Life Sciences can bring Continuous Validation to your Quality program, visit our website today and ask for a demo.