About the Client: The client is a 12-year-old biopharmaceutical company in the protein crystallography and formulation business.

The Engagement: RevereIT was engaged by the client to develop an understanding of the scientific processes underlying the business process within the company. The specific goal of the engagement was to identify a regulatory compliant scientific data management product that could be rapidly deployed within the company while offering an upgrade/customization path that will meet the future needs of the company. As a result of extensive of discussions, a number of high level user and functional requirements were identified. These requirements were prioritized based on their importance to the overall scientific and business processes and their impact to the near, mid and long-term business goals of the company. Based on these prioritized requirements product selection was accomplished. RevereIT and the client have also jointly developed an implementation plan for the company for this initiative that includes a roll out and customization plan for the different functional groups within the company over the next 18 months.

Computer Systems Validation

Computer System Validation (CSV) in regulated operations provides confirmation by examination and provision of objective evidence.

Validation for Vaccine Manufacturers An Introduction

This guidance document has been prepared to aid vaccine manufacturers in the preparation and performance of the validation studies required by GMP.