Case Study: CRIO, Inc. achieves independent Part 11/Annex 11 verification and market access with Advarra

Industry-Leading eSource Software Company Receives Part 11/ Annex 11 Verification

CRIO, Inc., the developer of the Clinical Research IO eSource system, faced growing customer expectations for formal Part 11 and Annex 11 compliance and needed an independent attestation to support wider adoption. CRIO engaged Advarra’s Data Protection and Compliance Service (Advarra®) to perform a Part 11/Annex 11 independent assessment and mock inspection to validate its computer system validation program.

Advarra deployed its proprietary Part 11/Annex 11 assessment and mock inspection, reviewing CRIO, Inc.’s GAMP 5–driven validation program, interviewing development and leadership teams, and recommending procedural updates. CRIO implemented the recommendations, satisfied the independent audit, and received Advarra’s statement of compliance—delivering verified program compliance, value-added business insights, and increased market penetration as customers can now confidently integrate the Clinical Research IO eSource system into their own Part 11/Annex 11 compliance programs.

CRIO, Inc

Raymond Nomizu

Co-Founder