Quality Assurance Case Studies
Beaufort has provided regulatory strategy and compliance, clinical research, and quality assurance services to both established and emerging biopharmaceutical and biologics companies. The following case studies describe specific solutions that we have tailor-made for our biopharmaceutical and biologics clients.
The US subsidiary of a large, international pharmaceutical company needed assistance in preparing for several regulatory inspections. A majority of the company’s clinical and regulatory staff had never participated in a regulatory inspection and anxiety levels were running high. Beaufort began the project by interviewing all pertinent personnel to establish their experience level and determine the company’s preparedness for the inspections. Our work included extensive document reviews, mock audits, extensive training sessions, both seminar and one-on-one. Beaufort also developed white papers to share with regulatory authorities during the inspections. We developed a series of mock inspections and follow-up activities, and the client passed all regulatory inspections with minimal audit findings, including a major FDA pharmocovigilance inspection.
The US subsidiary of large, international pharmaceutical company identified a broad range of actions to increase its readiness for an upcoming FDA inspection. These actions included a review and revision of their Quality Document System, a review of their Computer System Validation (CSV) Plan, and performing Vendor Audit Assessments. Beaufort performed an in-depth review of the company’s current document system, including meetings with all key stakeholders. This review led us to suggest several alternative document structures. The final project deliverables included an SOP Assessment Report, complete Document Index, revised SOPs, Flow Diagrams, Glossary of Terms and Definitions, and an SOP Writing Style Guide.
