If your life sciences company uses digital records, you have to follow the FDA’s 21 CFR Part 11. The rule sets the standard for making electronic records and signatures as trustworthy as paper.
A modern eQMS is built to handle these requirements, taking the technical burden off your team.
Who Can Access the System?
The first rule is making sure only the right people can get into the system. An eQMS manages this by giving every user a unique username and password.
More importantly, you can control exactly what each person can see and do once they’re logged in. An author might be able to edit a specific document, while a reviewer can only view it and add comments. This ensures that access is limited to a user’s specific job function, which is a key requirement of the regulation.
Tracking Every Change
21 CFR Part 11 requires a permanent, unchangeable log of every action taken on a record. A good eQMS does this automatically.
Think of it like a security camera for your data. Every time someone creates, modifies, or deletes a record, the QMS creates a secure, time-stamped entry. This audit trail shows who made the change, when they did it, and what was altered. This creates the complete, traceable history that auditors need to see.
Making Digital Signatures Count
For a digital signature to be as valid as a handwritten one, the FDA says it must have three key parts. An eQMS is designed to capture all of them in a single, seamless action.
When a user signs a document, the system requires them to:
- Confirm Who They Are: By re-entering their unique username and password.
- State Why They’re Signing: By selecting a meaning, like “Approved” or “Reviewed.”
- Record When They Signed: The system automatically captures the date and time.
The QMS permanently links these three elements to the record, creating a compliant and legally binding electronic signature.
Keeping Records Accurate and Safe
Finally, the regulation requires that your records remain accurate and secure over time. An eQMS manages this through built-in document and record controls.
Version control ensures that your team is always working from the most current, approved version of an SOP, which prevents costly mistakes. Once a record is finalized and signed, the system locks it to prevent any further changes. If an update is needed, you have to go through a formal revision process, which keeps the document history clean and traceable. This also gives you the ability to produce exact copies of any record, which is essential for audits.
The Path to Simplified Compliance
Ultimately, a modern eQMS takes the complexity out of complying with 21 CFR Part 11. It is designed to handle the technical requirements for access controls, audit trails, and electronic signatures, freeing up your team to focus on quality and innovation.
We’ve created a checklist to help you streamline the process.
Get your 21 CFR Part 11 checklist today.
