Your One Stop Solution for Life Sciences
In the biopharma and biotech industries, ensuring 21 CFR Part 11 compliance in digital systems is essential for regulatory compliance, data integrity, and audit readiness. Digital systems such as LIMS, ERP, MES, and electronic laboratory notebooks (ELN) must meet FDA requirements for electronic records and electronic signatures.
BioBoston Consulting helps life sciences organizations conduct comprehensive audits to verify compliance and maintain regulatory confidence.
What Is 21 CFR Part 11 Compliance?
21 CFR Part 11 sets the FDA requirements for:
- Electronic Records – Accuracy, integrity, and traceability
- Electronic Signatures – Authentication, non-repudiation, and accountability
- Audit Trails – Full tracking of record creation, modification, and deletion
Compliance ensures that your digital systems are secure, reliable, and audit-ready for FDA and EMA inspections.
Why Auditing Digital Systems Matters
Auditing digital systems ensures:
- Data integrity and accuracy across LIMS, ERP, MES, and ELN systems
- Regulatory compliance with 21 CFR Part 11 and GxP standards
- Audit readiness for internal and external inspections
- Identification of gaps and risks before they impact product quality or regulatory approval
Non-compliance can result in inspection observations, regulatory delays, and increased operational risk.
Steps to Audit for 21 CFR Part 11 Compliance
- Assess System Scope and Risk
- Identify all electronic systems subject to 21 CFR Part 11
- Evaluate system criticality and regulatory impact
- Prioritize audits based on risk and potential impact on product quality
- Review Access Controls
- Verify user authentication and role-based access
- Ensure appropriate segregation of duties and password policies
- Confirm that electronic signatures are unique and linked to user actions
- Evaluate Audit Trails
- Check that audit trails are complete, secure, and tamper-proof
- Ensure records capture who made changes, when, and why
- Validate system reports for accuracy and traceability
- Validate Data Integrity
- Review data handling, storage, and backup procedures
- Confirm that data is accurate, complete, and retrievable
- Verify system validation documentation (IQ, OQ, PQ)
- Document Findings and Implement CAPA
- Prepare audit reports with clear findings and recommendations
- Implement Corrective and Preventive Actions (CAPA) to address gaps
- Track CAPA completion and effectiveness for continuous compliance
Best Practices for 21 CFR Part 11 Audits
- Use a risk-based approach to focus on high-impact systems
- Maintain comprehensive documentation for inspections
- Provide training to staff on compliance and system use
- Conduct periodic re-audits to ensure ongoing compliance
How BioBoston Consulting Can Help
BioBoston Consulting provides end-to-end support for 21 CFR Part 11 audit programs, including:
- Evaluating LIMS, ERP, MES, and ELN systems for compliance gaps
- Conducting risk-based audits of electronic records and signatures
- Implementing CAPA programs to remediate non-compliance
- Preparing organizations for FDA, EMA, and global inspections
Our experts ensure your digital systems are compliant, secure, and audit-ready, minimizing regulatory risk.
Why Partner with BioBoston Consulting
✅ Expertise in 21 CFR Part 11 compliance and digital system audits
✅ Risk-based, efficient audit strategies for biopharma and biotech
✅ End-to-end support from planning to CAPA implementation
✅ Ensures data integrity, regulatory compliance, and audit readiness
Achieve 21 CFR Part 11 Compliance Today
A comprehensive audit program for digital systems ensures compliance, operational efficiency, and regulatory confidence.
Partner with BioBoston Consulting to audit your digital systems and achieve secure, compliant, and audit-ready operations.
📞 Contact us today to schedule your 21 CFR Part 11 audit consultation.