The 21 CFR Part 11 regulation mandates validation of computer systems used in FDA-regulated Good Practice (GxP) activities and regulatory filings. Because CYA solutions are protecting and recovering information residing in a FDA-regulated ECM application, Part 11 compliance and validation-readiness has been a key focus for enChoice. Since 1998, CYA solutions have been audited by leading pharmaceutical companies, and enChoice has created the documentation and test plans necessary for the qualification phase of the validation process. enChoice has leveraged its extensive experience to develop a five-day Rapid Deployment Service program including product validation. This program has enabled over sixty leading life sciences organizations including Boehringer Ingelheim, Biogen, and Centocor to deploy CYA solutions quickly and in compliance with FDA guidelines.
enChoice’s Rapid Deployment Service with FDA validation includes:
Analysis: Establishment of recovery time objectives and analysis of the ECM environment as it pertains to the CYA product implementation.
Installation: An engineer will install CYA products into a test environment, assess operational functionality, and move the products into a production environment once all is approved.
Validation: An Installation Qualification (IQ) document and Operation Qualification (OQ) document will be created to ensure compliance with government regulations. Test scripts will be provided to facilitate the testing process.
Training: All staff responsible for CYA products will be properly trained.
Post Installation Review: A configuration summary document is provided, and a smooth transition of the account to the CYA support team is facilitated. Contact Us To Learn More >
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