White Papers for Food and Drug Administration (FDA)

ABB Case Study Pfizer

The Pfizer Safety Sciences groups is located across 7 sites around the world and undertake preclinical activities vital to the development and introduction of new drug products within the Pfizer group. During a FDA inspection, spreadsheets were sited as a significant compliance concern, and improvements were required against spreadsheet validation and their compliance with 21 CFR Part 11. Following the FDA inspection Pfizer undertook the project with the aid of ABB Process Solutions. ABB's partner Wimmer Systems provided the technology that is necessary to enable Excel to be used in regulated environments. For this project, Wimmer Systems' DaCS system was chosen following a thorough investigation of potential solutions as well as the vendors ability to provide compliance and support worldwide.

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