A System Developer's Approach to Validation

BioPharm International, BioPharm International-03-15-2002, Volume 15, Issue 3

by Christopher L. Gent Pharmacia Corporation Validation is required for computer systems used to create, modify, maintain, archive, retrieve, or transmit data intended for submission. To ensure that the QA/QC and the IT departments speak the same language, a system developer will build documented evidence that a system's functionality has been tested, performs as specified, and generates reproducible results.