Specifications and Manufacturing Change Control: A Prototypic System for Electronic Document Tracking and Management

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

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.