- BioPharm International-03-15-2002
- Volume 15
- Issue 3
A System Developer's Approach to Validation
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.
Articles in this issue
over 23 years ago
Inside Washington: Biotech Manufacturing ? Obstacle or Opportunity?over 23 years ago
Guest Editorial: Warning Letters ? A Symptom?over 23 years ago
The Importance of Freezing on Lyophilization Cycle Developmentover 23 years ago
Business Benefits of Computer Systems ValidationNewsletter
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