SureClinical Wins FDA Part 11 and EC Annex 11 Compliance Validation

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

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.

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