EDMS Based QA/QC Documentation: the Lasting Answer to GxP Challenges

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Published 28 September 2011 | By Infotehna Group

In all GxP areas, document handling is one of the most exposed areas when it comes to regulatory inspections. While good document management system cannot by itself ensure the favourable result of an inspection, the lack of it is almost sure to ruin the company’s high expectations, even if there is nothing essentially wrong with the presented data. In order to deal with all the documentation pertinent to the challenges in GxP environment, INFOTEHNA developed QualityExpert. QualityExpert is the solution based on INFOTEHNA proprietary application myProcess, which ensures the compliance with all regulatory requirements, including 21CFR11. In addition, myProcess is the base for all other INFOTEHNA myPharmaExpert Suite solutions, which ensures 100% cross-solution compatibility.

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