Rancho Cordova, CA (PRWEB) August 01, 2013
SureClinical, a provider of cloud-based content management application software and services for health sciences, announced today that it has successfully completed an FDA 21 CFR Part 11 compliance audit of its SureTrial® eTMF clinical trials content management application. More information is available at http://www.SureTrial.com.
Conducted through a leading independent GxP process auditing organization, SureTrial’s successful audit will help sponsors, clinical research organizations, academic research organizations and investigator sites running clinical trials comply with FDA rules and regulations related to electronic records and electronic signatures used in Electronic Trial Master File, or eTMF implementations.
“SureTrial eTMF is the first eTMF cloud software solution that completely addresses FDA 21 CFR Part 11 regulations and that has successfully completed an independent audit and validation,” said Zack Schmidt, President and CEO of SureClinical. “With the independent audit and validation of SureTrial eTMF, life sciences organizations can accelerate their compliance and validation initiatives for faster application deployment, insuring higher levels of GxP process management with eTMF documents and medical images.”
The FDA 21 CFR Part 11 compliance audit was performed by a leading independent GxP process organization that provides training to industry and US FDA regulatory agency personnel on 21 CFR Part 11 regulated computerized systems. The audit covered requirements for electronic records and electronic signatures under 21 CFR Part 11.
SureClinical is a provider of cloud-based content management application software for health sciences. Headquartered in the Northern California, SureClinical’s founders have prove
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