- BioPharm International-03-15-2002
- Volume 15
- Issue 3
Specifications and Manufacturing Change Control: A Prototypic System for Electronic Document Tracking and Management
by Robert Zeid TLI Development The corporate fantasy where everyone knows all the systems all too often collides with a nightmare reality where all the systems are known by only a few. Any specification or manufacturing change that affects various departments can quickly become a bewildering morass of proposed, actual, and implemented changes ? with few connections to actual lots and practices. Draw a line in the CMC "sand" where those changes actually began.
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 Validationover 23 years ago
A System Developer's Approach to ValidationNewsletter
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