Protocol deviations, informed consent violations, ineligible subject enrollments, etc., are problems that have plagued clinical research for decades and are still widespread today. As the scope and effectiveness of training and quality programs increase, one would hope that the frequency of errors would reduce comparatively. Even so, many product development programs that invest significant time, money and technologies into risk mitigation still encounter repetitive process errors including manufacturing deviations, product release inefficiencies, protocol deviations, informed consent violations and ineligible subject enrollments.
At Beaufort, we see the practice of quality management as a way to save time and money by improving quality across all GxP processes. Our team will help you evaluate, refine and implement optimal quality management procedures to support every aspect of your research or manufacturing program. From the way you’re educating personnel, to how you’re reviewing data integrity and ensuring that your program yields substantial and communicable results and products, Beaufort is your quality management partner.
Quality System Assessment and Support
Sound clinical research starts with a robust system built to address challenges before they become problematic. Beaufort offers comprehensive quality system assessment and support aligned with the concept of problem prevention.
- Gap analysis to applicable standards
- Risk management
- Quality system design and implementation
- Quality system training
- SOP design, harmonization and implementation
Corrective and Preventive Action (CAPA) Management
Managing the corrective and preventive action (CAPA) process is essential when looking at process improvements. Our team will support the management of your CAPA systems to ensure actions are properly recorded and dealt with in a timely manner.
- CAPA system design and implementations
- Root cause analysis
- Tracking CAPAs
- Analyzing for critical trends
- Prevention of recurring non-conformances
- Reports to facilitate continuous improvement
Our quality and compliance professionals will ensure your program achieves the highest level of compliance.
- Quality system audit execution (FDA QSR, ISO 13485, etc.)
- Inspection and audit readiness (FDA, European Notified Body, Brazil’s ANVISA, etc.)
- Quality system and regulations training
- FDA 483 responses
- Warning letter remediation
Beaufort offers extensive global experience in supplier base management from clinical trials, to product launch and beyond.
- Supplier audits
- Supplier management programs
- Strategic sourcing
Inspection Readiness and Support
Beaufort has extensive experience helping companies of all sizes prepare for regulatory inspections and will help you with all aspects of the inspection process.
- Mock inspections — interviews
- CAPA management
- Inspection management
- Post-inspection support