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21 CFR Part 11, EU Annex 11 & MHRA: A Compliance Checklist for QC Labs

For QC labs, especially those in regulated industries like pharma, biotech, and cannabis, compliance with data integrity standards is non-negotiable. But if you’re a small or growing lab, navigating regulations like 21 CFR Part 11, EU Annex 11, and the MHRA’s GxP data guidance can feel overwhelming. The good news? You don’t need a team of consultants to get this right. This guide walks you through a practical, easy-to-follow compliance checklist that aligns with the core regulations in the US, UK, and EU, helping your lab stay inspection-ready without overcomplicating things.

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

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Compliance Checklist for Electronic Records and Signatures

Use this checklist to benchmark your lab’s setup against the key pillars of compliance:
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✅ 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

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✅ 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

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✅ 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

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✅ 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

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✅ 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

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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

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