From Daily Operations to Audit Spotlight: Standardizing Document Management and Quality Assurance Collaboration

About this session

Part of Session 3, Track E: Site, Sponsor & Service Provider Partnerships (Chair: Sarah Dean, Precision for Medicine).

In the era of connected digital TMFs, true inspection readiness demands seamless cross-functional collaboration. While Quality Assurance serves as primary audit host and contact point, the Document Management department (DocM) is responsible for ensuring the system remains in a state of permanent compliance. This presentation focuses on efficient DocM strategies for maintaining an inspection-ready environment at all times through proactive oversight and standardized preparation.
Drawing from our procedural framework for external audits, we detail the processes of managing audit inspector access securely. We focus on how DocM ensures the eTMF is prepared for transparent viewing by granting read-only permissions only after mandatory system training, with access revoked promptly following the close-out meeting. By bridging the gap between daily DocM and the audit event, DocM and Quality Assurance work in tandem to transform the eTMF into a reliable tool that is always prepared to demonstrate data integrity and full regulatory compliance.

Speaker

• CI

  Cristina Iannaccone

  SGS

  Speaker