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SureClinical Wins FDA Part 11 and EC Annex 11 Compliance Validation

Dec 1, 2014 11:54:19 PM / by Shanmugavel Sankaran posted in FixNix GRC, Governance, incident management, Risk Management, Sure Clinical, asset management, audit management, BCM, Blog, cloud GRC, compliance, policy management, risk


SureClinical, a global provider of cloud-based content management application software and services for health sciences, announced today that it has successfully completed an independent FDA 21 CFR Part 11 and European Commission Annex 11 compliance audit of its SureClinical® eTMF Cloud eTMF clinical trials content management application. The audit opinion letter is freely available to prospective SureClinical customers at

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