Ensure quality, consistency, and full regulatory compliance
At Beaufort, we recognize the critical importance of ensuring the quality, safety, and integrity of your clinical trial. This is why our entire organization and culture are built upon a firm commitment to quality and performance – which serves as the overarching principle across everything we do for clients. Our team is composed of skilled GxP professionals that offer expert guidance and help drive your program success.
Quality Assurance Services
Our team will help you evaluate, refine, and implement optimal quality management procedures to support every aspect of your research or manufacturing program.
- FDA (21 CFR 820), ISO 9001, ISO 13485, IVDR
- Identification of quality system processes, linkages and interdependencies
- Risk management activities
- SOP and template writing and review
- SOP implementation and employee training
- CAPA processes
- Quality system audits
- Quality system maintenance
- Notified body selection
Beaufort offers comprehensive quality system assessment and support aligned with the concept of problem prevention.
- New market entry
- Conformance to changing regulations and industry standards
- Transitions management (e.g., CAP/CLIA to 21 CFR 820, ISO 13485 or IVDR)
- Quality system assessment and support
- Gap analysis to applicable quality standards and regulatory requirements
- Risk management throughout product lifecycle
- Quality system design and implementation
- Quality system training
- SOP design, harmonization, and implementation.
- Corrective and preventive action (CAPA) management
- Root cause analysis
- Tracking CAPAs
- Analyzing for critical trends
- Prevention of recurring non-conformances
- Reports to facilitate continuous improvement
- Evaluation and/or preparation of measures of effectiveness for CAPAs
We know what regulatory agencies look for and how you can best plan and facilitate reviews and inspections to help ensure research and data integrity.
- Clinical site audits
- Supplier qualification and assessment
- Audit plan and report development
- Interviews with staff
- Documentation reviews
- Internal and external auditing including:
- Quality system regulation (QSR)
- Good clinical practices (GCP)
- Good manufacturing practices (GMP)
- BIMO preparatory and investigative site audits
- Vendor and supplier audits
Beaufort has extensive experience helping companies prepare for successful regulatory inspections.
- FDA (QSIT, BIMO), notified body, JPAL, CAP/CLIA
- Mock audits/regulatory inspections
- Inspection readiness training for sponsor staff
- Inspection participation
- Investigator site training for regulatory inspections
- Regulatory inspection response management