With Part 11 compliant systems now available for investigator sites to streamline processes, some of us are wondering what exactly is 21 CFR Part 11 and why is it important? Essentially, 21 CFR Part 11 regulations define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Basically, Part 11 allows companies to replace any paper record or hand written signature with an electronic record/signature.
For years now, computers have made individuals more productive while eliminating costs associated with paper-based systems. It’s natural that investigator sites are now wanting to replace paper with electronic records to boost efficiency. The truth is, every investigator site already has electronic records but most companies are so unsure of Part 11 compliance that they resort to printing paper in fear of being non-compliant with regulations. Instead of fearing Part 11, it’s much more beneficial to embrace these regulations and realize that Part 11 compliance is not complicated. Can you imagine a research site with a lot less paper? Not only does Part 11 make this possible, many research sites are already leading the way to an electronic future by adopting systems that manage their regulatory documentation electronically.
While Part 11 regulations are essential and helpful, many would argue that the actual document lacks detail on implementation. With the lack of detail, the FDA has since provided guidance documents to assist in implementation and the industry has adopted standards to ensure compliance.
There are three primary areas of 21 CFR Part 11 compliance:
1) Standard Operating Procedures – The software vendor will have about 10 or more SOPs to address their IT infrastructure. These SOPs include, but are not limited to, Data Backup, Data Security, Computer System Validation, and other aspects of computer systems that support electronic records and signatures. It’s important for research sites to explore their own IT infrastructure to ensure SOPs that maintain compliance at the site level.
2) Computer system features – There are numerous standard product features that are implemented to ensure computer system security and data integrity. These features include complete audit trails, access controls, record retention and electronic signatures.
3) Computer System Validation – Part 11 compliant systems must have documented evidence that the system does what is intended. Furthermore, users should be trained to detect when the system is not working as intended.
Through Part 11 regulations, the FDA has paved the way to an electronic future for research sites. Adopting a Part 11 system doesn’t take an act of faith but it does require a systematic approach to compliance. If you want to see how other sites are ditching the paper regulatory binders and moving towards electronic freedom, visit our website to learn more about RealTime-eDOCS. Better yet, contact us for an online demo to see the system in action!
FAQ: 21 CFR Part 11 & ereg Systems
Q: Is Part 11 compliance required for all clinical trial systems?
A: Any system used to maintain or sign official trial documentation electronically must comply with 21 CFR Part 11. This includes eReg/eISF, eSource, and electronic signature workflows tied to regulated records.
Q: Does using email or PDFs with signatures count as compliant?
A: No. While convenient, unsigned PDFs or email-based approvals do not meet Part 11 criteria for audit trails, identity verification, or secure access.
Q: What should I ask a vendor to ensure their system is compliant?
A: Request documentation of their SOPs, audit trail functionality, electronic signature security, and computer system validation. Ask how they support your site’s own compliance readiness.
Q: Will I need to hire IT staff or external consultants to become compliant?
A: Not necessarily. RealTime’s eRegulatory solutions are intuitive, validated, and turn-key. Our Professional Services teamsupports sites through implementation, training, and ongoing optimization—so you can stay audit-ready without bringing in outside consultants. Plus, with 24/7 customer support, help is always just a call or click away, whenever you need it.
Q: Is validation my responsibility or the vendor’s?
A: The vendor is responsible for validating the system at the development level. However, sites are responsible for user-level validation – meaning proper training, SOPs, and system usage aligned with your workflows.
Q: Will this make inspections easier?
A: Yes. With RealTime’s eReg/eISF systems, inspectors can view everything they need in one place – no binders, no digging, and no confusion over document versioning or access logs.
