LCGC Europe: Questions of Quality: Cost Beneficial Validation of a Site-Wide Chromatography Data System

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LCGC Europe (Jens Donath and R.D. McDowall)
LC/GC Europe
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The implementation and validation of a new site-wide chromatography data system for a major active pharmaceutical ingredient custom manufacturer provided the opportunity to map and optimize the GMP and ISO business processes to use electronic signatures effectively. This article describes the process optimization and how it integrates with the validation activities of the system. This overall approach provides substantial business benefits from the use of electronic signatures as evidenced by the savings resulting from process improvement and by the fact that the non-GMP laboratories implemented a similar process to analyse and approve results electronically.

This article is reprinted (in pdf format) with permission from LCGC Europe.

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720001529en PDF 128.35kB