Challenge: The U.S. subsidiary of a large, international pharmaceutical company identified a broad range of actions to increase its readiness for an upcoming FDA inspection.

Beaufort Solution: These actions included a review and revision of its Quality Document System, a review of its 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.

Date posted: October 27, 2011

Categories: Case Studies Quality Assurance & Compliance