CaseBioscience joins an ARPA-H effort to develop room-temperature cell therapy preservation, Novartis licenses an mRNA-encoded T-cell engager from Abogen, and AstraZeneca, Daiichi Sankyo, and Summit plan to combine Datroway with ivonescimab.
|Articles|March 15, 2002
- BioPharm International-03-15-2002
- Volume 15
- Issue 3
A System Developer's Approach to Validation
Author(s)Christopher L. Gent
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.
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Inside Washington: Biotech Manufacturing ? Obstacle or Opportunity?over 24 years ago
Guest Editorial: Warning Letters ? A Symptom?over 24 years ago
The Importance of Freezing on Lyophilization Cycle Developmentover 24 years ago
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