This document provides an overview of challenges facing the life sciences industry and discusses validation requirements for computer systems. It contains the following information:
- The pharmaceutical, medical device, and biotechnology industries face issues like loss of revenue from generics, high costs to develop new drugs, and new regulations. Computer validation is important in these regulated industries.
- FDA validation requirements are defined as demonstrating through documented evidence that a system consistently operates according to predetermined specifications. Validation ensures quality, objectivity, and that developers cannot check their own work.
- A validation toolkit is presented that follows GAMP 5 guidelines and parallels an established validation methodology. It contains templates, scripts, and tools to help customers efficiently validate computer systems in a