Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
News|Articles|October 2, 2002
- Pharmaceutical Technology-10-02-2002
- Volume 26
- Issue 10
An Overview of the Validation Approach for Moist Heat Sterilization, Part II
Author(s)E. Pretorius, PhD
Part II of this article describes the installation, operational, and performance qualification of an autoclave and discusses a system for change control.
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