FDA 21 CFR Part 11
FDA 21 CFR Part 11 is the standard for secure, compliant digital records and signatures in regulated industries
FDA 21 CFR Part 11 is a regulation from the U.S. Food and Drug Administration (FDA) that defines what’s needed for electronic records and signatures to be considered just as valid as their paper-based counterparts. Introduced in 1997, it remains one of the most important standards for digital compliance in regulated industries.
If you work in life sciences, pharmaceuticals, food production or laboratory environments and you use electronic systems to handle regulated data, Part 11 compliance isn’t optional, it’s an essential. It makes sure your data is reliable, traceable and legally acceptable.
What does FDA21 CFR Part 11 require?
To meet Part 11 requirements, your digital systems need to follow a few key principles:
- Data integrity: Records must be accurate, complete and protected against tampering or unauthorised access.
- Audit trails: Every action taken must be logged, who did what, when and why, with no way to overwrite or erase the history.
- Electronic signatures: Sign-offs must be secure, unique to each user and carry the same legal weight as a handwritten signature.
These controls are in place to guarantee digital records are just as trustworthy as paper ones, something that’s important in highly regulated industries.
How is this different from system validation?
Validation checks whether a system does what it's supposed to do. Part 11 goes a step further, it outlines what that system must do in a regulated context, especially when electronic records or signatures are involved.
So even if your system is validated, it still needs to meet the specific requirements of Part 11 to be fully compliant.
Which systems need to comply with Part 11?
Any system used to create, store, manage or sign electronic records in a regulated setting may fall under Part 11. This includes:
- Quality Management Systems (QMS)
- Laboratory Information Management Systems (LIMS)
- Manufacturing Execution Systems (MES)
- Digital batch records and audit logs
- Cloud-based monitoring tools (like RmoniWeb)
If the data from these systems is used to make regulatory decisions or submitted to the FDA, compliance with Part 11 is a must.