Our gap analysis and CAPA services are grounded in a deep understanding of the regulations, standards, and inspection trends that drive enforcement across the life sciences. We assess your systems against the most relevant and impactful regulatory requirements, helping you proactively close gaps that could trigger inspection findings. The list below represents our major areas of assessment focus. This is not exhaustive—talk to us for more details.
U.S. FDA Regulations
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21 CFR Part 820 – Quality System Regulation (QSR)
Core framework for medical device quality systems. Assessed against current QSR and transition readiness for the upcoming Quality Management System Regulation (QMSR) aligned with ISO 13485. -
21 CFR Part 211 – Current Good Manufacturing Practices (CGMP) for Finished Pharmaceuticals
Evaluated in pharma and combination product contexts, especially for systems like documentation, equipment, and process controls. -
21 CFR Part 210 – CGMP for Manufacturing, Processing, Packing, or Holding Drugs
Focus on manufacturing environment, personnel qualifications, and production controls. -
21 CFR Part 11 – Electronic Records and Signatures
Reviewed when quality data is maintained electronically. We assess system validation, access control, and audit trails. -
21 CFR Part 803/806 – Medical Device Reporting and Corrections/Removals
Analyzed for post-market surveillance gaps, adverse event reporting, and field correction procedures. -
FDA Inspection Guides and Enforcement Trends
We evaluate quality systems through the lens of FDA’s current inspection focus areas, including:-
Complaint handling and MDRs
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CAPA and root cause analysis rigor
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Data integrity and documentation
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Risk management and design controls
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Supplier controls and purchasing records
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CAPA effectiveness and trend analysis
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International Standards
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ISO 13485:2016 – Medical Devices Quality Management Systems
Global baseline for medical device quality. Gap analyses evaluate clause-by-clause conformance, particularly for companies targeting MDSAP markets. -
ISO 14971:2019 – Risk Management for Medical Devices
Critical for integrating CAPA with proactive risk-based decision-making and preventive action. -
ICH Q10 – Pharmaceutical Quality System
Used to evaluate pharma manufacturing organizations' quality systems from a lifecycle management and continuous improvement perspective. -
EU MDR and IVDR Requirements (as applicable)
For clients operating in the EU, gap analyses can cover CAPA integration within technical documentation, PMS/PSUR systems, and clinical evaluation frameworks.
Focused System Areas We Prioritize
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CAPA Program Structure
Assessed for root cause analysis rigor, timely implementation, documentation, and effectiveness checks. -
Internal Audit and Management Review
Reviewed as key drivers of systemic gap identification and continuous improvement. -
Supplier and Change Control
Common gap areas related to oversight, qualification, and response to non-conformances. -
Documentation and Record Control
Evaluated for completeness, traceability, and compliance with data integrity expectations. -
Training Systems
Verified for procedural coverage, personnel qualifications, and documentation of effectiveness.
