Computer Validation As It Pertains To 21 CFR Part 11 - ISA 2002

About

The FDA’s 21 CFR Part 11 has hit the Pharmaceutical Industry like a firestorm. Most Pharmaceutical companies understand that process data needs to be saved and stored in new way, but they are unsure to what process data 21 CFR Part 11 pertains and how to store it. This paper will describe the recent history of process data collection. Some specific terms will then be defined. The process data itself will be described and implementation issues and validation strategies will be discussed.

- Downloadable files require Adobe Acrobat Reader.

Customers who bought this product also bought: Applying XML for Integrating Batch Management with the Enterprise - ISA 2001 Opportunities for FDA Regulated Industries - ISA 2001 Validation (GAMP, FDA,...) and S88 Standards for Batch and Recipe Management Systems - INTERKAMA 1999 Automation Solutions Digital Library (Online) *Security-Online Collection of Technical Papers