21 CFR Part 11, EU Annex 11 & MHRA: A Compliance Checklist for QC Labs
What Is 21 CFR Part 11 (and How Does It Compare to Annex 11 & MHRA Guidelines)?
21 CFR Part 11 is the FDA’s regulation for electronic records and electronic signatures. It applies to any lab or organization submitting electronic data to the FDA. Annex 11, from the European Medicines Agency (EMA), serves a similar purpose across the EU. The MHRA in the UK also outlines expectations for data integrity under GxP guidelines, particularly for labs working under GMP or GLP.
At their core, all three frameworks expect labs to:
- Maintain secure, traceable records
- Use electronic signatures responsibly
- Validate software systems they use
- Prove that data hasn’t been altered or lost
Why This Matters for Small & Mid-Sized QC Labs
If your team still uses spreadsheets, shared folders, or manual forms, it’s hard to:
- Show who entered what data — and when
- Prevent accidental (or intentional) changes
- Prove you’re following a consistent workflow
And while bigger labs might throw resources at the problem, smaller labs often don’t have that luxury. The solution? Get your systems working for you.
🔗 How LIMS Can Help Standardise Your Laboratory Processes
Compliance Checklist for Electronic Records and Signatures
Use this checklist to benchmark your lab’s setup against the key pillars of compliance:
✅ System Validation
Required by: 21 CFR Part 11 | EU Annex 11 | MHRA GxP
- Have you validated your LIMS or software for its intended use?
- Do you have documented test results and sign-offs?
- Is your validation reviewed periodically?
🔗 LIMS Deployment: A Guide to Successful LIMS Implementation
🔗 Validation: Checklist for LIChecklist for Successful LIMS DeploymentMS Software Validation
✅ Role-Based Access & User Authentication
Required by: 21 CFR Part 11 | Annex 11 | MHRA
- Does every user have a unique login?
- Are permissions managed based on user roles (e.g., tech vs QA)?
- Are logins secure and time-limited?
🔗 Data Security & Compliance: The Importance of Audit Trails
✅ Audit Trails & Data Integrity
Required by: 21 CFR Part 11 | Annex 11 | MHRA
- Can your system track every action (edit, deletion, approval)?
- Are all audit logs time-stamped and user-specific?
- Can you search by sample ID, date, or user?
🔗 Top LIMS Features to Ensure Quality in Your Lab
✅ Electronic Signatures
Required by: 21 CFR Part 11 | Annex 11
- Are e-signatures unique to each individual?
- Do they log when, why, and by whom the data was approved?
- Are they tamper-proof and traceable?
🔗 Lab Manager’s Guide to Reviewing Test Results for Accuracy & Compliance
✅ ALCOA+ Principles
Required by: All regulatory bodies
These principles help define good data integrity practices:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
(+ Complete, Consistent, Enduring, Available)
How to Get Started Without IT Overheads
You don’t need a large IT department or big budget. Labs using LabHQ are often:
- Live with LabHQ in their lab, in under a day
- Fully supported (no IT staff required)
- Compliant, out-of-the-box
If you’re building your lab’s digital foundation, start here:
🔗 Getting Started Checklist for LIMS
🔗 How to Choose the Right LIMS for Your Lab
Final Thoughts: Small Labs Can (and Should) Be Compliant
Compliance doesn’t have to be complicated or expensive. With the right tools and processes, small QC labs can:
- Stay audit-ready at all times
- Ensure trust in every result
- Scale confidently as the business grows
Want to see how LabHQ simplifies 21 CFR Part 11, Annex 11, and MHRA data integrity in practice?
👉 Book a demo or take our interactive walkthrough
