Rancho Cordova, CA (PRWEB) November 30, 2014
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 http://www.sureclinical.com/sureclinical-etmf-compliance-2014/
Conducted through a leading independent process auditing organization, SureClinical’s compliance and quality processes will help sponsors, clinical research organizations, academic research organizations and investigator sites evaluating cloud vendor solutions for use in clinical trials gain assurance and confidence. The compliance opinion states that SureClinical’s cloud, applications, and electronic signing infrastructure meets or exceeds stringent regulatory requirements for electronic systems set forth by the European Commission and the FDA.
“SureClinical is the first eTMF cloud software solution vendor to independently validate and publish its solution against stringent FDA 21 CFR Part 11 and EC Annex 11 regulations and GAMP 5 guidelines,” said Zack Schmidt, President and CEO of SureClinical. “With this independent validation, our customers can accelerate their pre-deployment compliance and vendor validation initiatives for faster application deployment and rapid study startup. The independent compliance opinion demonstrates SureClinical’s ongoing commitment to quality in its cloud operations, software development, customer support, vendor qualification and staff training processes.”
The compliance audit was performed by a leading independent GxP process organization that provides system compliance audits and training to industry and to US FDA regulatory agency personnel on 21 CFR Part 11 regulated computerized systems. The audit covered 21 CFR Part 11, Electronic Records; Electronic Signatures validation requirements, GAMP 5 (Good Automated Manufacturing Practices) compliant computer systems validation and EC Annex 11 regulations.
The audit demonstrates that SureClinical’s cloud operations, applications and electronic signing features meet applicable FDA and EC Annex 11 requirements in these areas:
Data center facility certification
Design and development process and procedure
Software development lifecycle processes including:
Development of user requirements and functional specifications
Traceability between specifications and testing protocols
Software testing processes
Final software certification process
Release to production process
Project, testing and validation documentation for SureClinical eTMF Cloud products
Compliance with 21 CFR Part 11, Electronic Records; Electronic Signatures regulations
Audit trails
Protection of records
Staff training processes
Training certificates and staff qualification
Vendor evaluations
Selection and qualification of software tools
Operating procedures for backup, recovery, maintenance and business continuity
Personnel and data security policies
SureClinical's eTMF Cloud Compliance White Paper, dated November 21, 2014 was also independently audited
Additionally, SureClinical announced the availability of mirrored study environments and early access to software releases, software test scripts and release briefings for customers that need additional validation resources.
About SureClinical
Recognized as one of the Top 30 Life Science Startups in the US in 2014 by BioSpace, SureClinical is a leading provider of FDA and EC compliant cloud-based content management application and Esigning solutions for health sciences.
SureClincal's solutions are used in global clinical trials by leading clinical trial sponsors, clinical research organizations and clinical trial investigators. Headquartered in Northern California, SureClinical has proven expertise in delivering market leading enterprise cloud applications in the health sciences and enterprise mobile computing areas. For more information visit http://www.sureclinical.com/
Trademarks
SureClinical, SureTrial®, SureTrial® eTMF are trademarks of SureClinical.
Copyright © 2014 SureClinical. All rights reserved. SureClinical, SureClinical eTMF and the SureTrial logo are trademarks of SureClinical. Other names used herein may be trademarks of their respective owners.
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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 http://www.sureclinical.com/sureclinical-etmf-compliance-2014/
Conducted through a leading independent process auditing organization, SureClinical’s compliance and quality processes will help sponsors, clinical research organizations, academic research organizations and investigator sites evaluating cloud vendor solutions for use in clinical trials gain assurance and confidence. The compliance opinion states that SureClinical’s cloud, applications, and electronic signing infrastructure meets or exceeds stringent regulatory requirements for electronic systems set forth by the European Commission and the FDA.
“SureClinical is the first eTMF cloud software solution vendor to independently validate and publish its solution against stringent FDA 21 CFR Part 11 and EC Annex 11 regulations and GAMP 5 guidelines,” said Zack Schmidt, President and CEO of SureClinical. “With this independent validation, our customers can accelerate their pre-deployment compliance and vendor validation initiatives for faster application deployment and rapid study startup. The independent compliance opinion demonstrates SureClinical’s ongoing commitment to quality in its cloud operations, software development, customer support, vendor qualification and staff training processes.”
The compliance audit was performed by a leading independent GxP process organization that provides system compliance audits and training to industry and to US FDA regulatory agency personnel on 21 CFR Part 11 regulated computerized systems. The audit covered 21 CFR Part 11, Electronic Records; Electronic Signatures validation requirements, GAMP 5 (Good Automated Manufacturing Practices) compliant computer systems validation and EC Annex 11 regulations.
The audit demonstrates that SureClinical’s cloud operations, applications and electronic signing features meet applicable FDA and EC Annex 11 requirements in these areas:
Additionally, SureClinical announced the availability of mirrored study environments and early access to software releases, software test scripts and release briefings for customers that need additional validation resources.
About SureClinical
Recognized as one of the Top 30 Life Science Startups in the US in 2014 by BioSpace, SureClinical is a leading provider of FDA and EC compliant cloud-based content management application and Esigning solutions for health sciences.
SureClincal's solutions are used in global clinical trials by leading clinical trial sponsors, clinical research organizations and clinical trial investigators. Headquartered in Northern California, SureClinical has proven expertise in delivering market leading enterprise cloud applications in the health sciences and enterprise mobile computing areas. For more information visit http://www.sureclinical.com/
Trademarks
SureClinical, SureTrial®, SureTrial® eTMF are trademarks of SureClinical.
Copyright © 2014 SureClinical. All rights reserved. SureClinical, SureClinical eTMF and the SureTrial logo are trademarks of SureClinical. Other names used herein may be trademarks of their respective owners.
Help employers find you! Check out all the jobs and post your resume.
