Top Audit Questions on 21 CFR Part 11 and How to Answer Them
📌 Introduction
Preparing for a 21 CFR Part 11 audit can be intimidating—especially when you’re unsure what the auditor might ask. This regulation governs the use of electronic records and signatures in regulated industries like pharmaceuticals, biotech, and medical devices. Non-compliance can result in warning letters, import bans, or even shutdowns.
This guide breaks down the top audit questions on 21 CFR Part 11 and provides practical, audit-ready answers. Whether you’re in QA, IT, or Regulatory Affairs, this is your go-to checklist to stay compliant and confident.
📚 What Is 21 CFR Part 11?
21 CFR Part 11 is a regulation by the U.S. FDA that specifies how electronic records and electronic signatures must be handled to ensure data integrity, security, and authenticity. It applies to any pharma, biotech, or life sciences company using software to store regulated information.
Key concepts covered under this rule:
- Validation of systems
- Secure user access
- Audit trails
- Electronic signature authentication
- Data backup and retrieval procedures
🕵️♂️ Top 21 CFR Part 11 Audit Questions & Sample Answers
1. Is your computerized system validated?
✅ Answer:
Yes, we follow a risk-based validation lifecycle that includes URS, IQ/OQ/PQ, and validation summary reports. All systems are validated in compliance with GAMP 5 and FDA guidelines.
2. Can you show evidence of electronic signature controls?
✅ Answer:
Our system uses unique user IDs and passwords to authenticate signatures. Each signature is timestamped and linked to the corresponding electronic record per 21 CFR Part 11 requirements.
3. Is there an audit trail enabled for every critical action?
✅ Answer:
Yes, audit trails are automatically generated and capture date/time, user identity, and changes made to critical records. These logs are secure, tamper-proof, and regularly reviewed.
4. How do you control access to your systems?
✅ Answer:
We implement role-based access control (RBAC) using user authentication via Active Directory. Only authorized personnel have access to specific functions and data.
5. How do you ensure backup and disaster recovery?
✅ Answer:
We perform daily backups of critical data. A disaster recovery plan is in place and tested bi-annually to ensure system restoration within 24 hours.
6. Are your SOPs aligned with 21 CFR Part 11 requirements?
✅ Answer:
Yes, we have SOPs on system validation, data integrity, audit trail review, and electronic signature usage that are regularly reviewed and trained on.
🔐 Key Compliance Areas to Review Before the Audit
- System Validation Documents
- User Access Matrix
- Audit Trail Reports
- Training Records on 21 CFR Part 11
- Electronic Signature Authorization Forms
- Incident Reports and CAPAs related to data integrity
💡 Pro Tips for Audit Preparation
- Conduct mock audits using these questions.
- Review system logs and audit trails weekly.
- Keep SOPs digitally signed and version-controlled.
- Maintain training records on Part 11 for all system users.
- Use checklists before the audit to avoid common pitfalls.
📊 Stats That Matter
- 🔍 According to the FDA, over 65% of warning letters in pharma involve data integrity issues.
- 🧾 Electronic records violations were among the top 5 citations in recent FDA audits (2022).
- ✅ Companies with validated systems and clear audit trails pass FDA audits 3x more efficiently.
❓ FAQs
Q1: Who needs to comply with 21 CFR Part 11?
Any life sciences company using electronic records/signatures in regulated processes must comply.
Q2: What’s the biggest risk during a 21 CFR Part 11 audit?
Lack of system validation and missing audit trails are among the most critical red flags.
Q3: Is Excel Part 11 compliant?
Only if used within a validated system with audit trail and access controls—it isn’t compliant out-of-the-box.
📌 Conclusion: Be Audit-Ready, Stay Compliant
21 CFR Part 11 audit questions are a test of your organization’s digital maturity and data integrity. Knowing what to expect—and how to respond—can make the difference between a smooth audit and a compliance nightmare.
📥 CTA: Need help with a 21 CFR Part 11 gap assessment or mock audit? Contact Our Compliance Experts Today!
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