Pharmaceuticals, BioScience and Associated Industries
Imagine if Proven Technology took care of FDA, Annex, and Sarbanes-Oxley (SOX) Industry Regulations for you...
Companies in the pharmaceutical, biotech, and medical device industries are continually looking for innovative ways to bring new products to market faster. It is critical to maximize market success and lower product liabilities by reducing the risk through validation and maintaining compliance with government regulations. By keeping track of accurate engineering information throughout the organization and by making it accessible to the appropriate people, production flaws can easily be avoided.
Seven of the world’s top 10 FDA-regulated manufacturers use BlueCielo’s asset information management solution with its unique, compliance-accelerating FDA module, to manage GMP engineering documentation throughout the plant. BlueCielo's solution helps to maintain 21 CFR Part 11 compliance, while facilitating efficient documentation flow between Engineering, Operations, Quality and Contractors
If you would like more information, request a whitepaper, or speak to an ECM Specialist regarding this module Contact us
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