Client: The client is a mid level biotechnology company that develops cancer treatment solutions by combining functional genomics and antigen-discovery technology with its proprietary biotechnology capabilities.

Engagement: RevereIT was engaged by the client to develop a strategy and gather requirements for an application to house biological pathway data. The specific goals of the engagement were to work with leaders within the entire client organization who heavily use biological pathway information and their research groups to develop a business case for using biological pathways as a central tool in the client’s business processes, as a knowledge management tool as well as to gather requirements from the users and super-users (the Bioinformatics department). RevereIT also developed a roadmap for the development and implementation of the proposed solution.

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.