Challenge • Wanted to be IS0 9001 compliant to facilitate the possibility of certification in the future. • Needed to implement a Quality Management system, involving approximately 150 users, to stabilize the company’s business processes. • Needed to replace paper-based processes and eliminate inefficiencies when creating and distributing relevant documentation. • Required a system that would ensure criteria is met regarding acceptable documentation by the FDA (CFR part 11). • Wanted a system that could support the reorganization of the company and its evolving needs. Solution • Implemented Intelex’s Quality Management system. • Special focus on Document Control (loaded over 3,000 documents to date). • Extensive ongoing support including responsive and knowledgeable client service

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