CRO: eTMF + EDC Ecosystem for Clinical Trials (Part 11 + vendor model)
What we succeed?
As a result of the partnership we established with Validfor, our test cycles shrink from weeks to days through one structured digital workflow and full visibility, traceability and audit rediness.
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The Problem
Multi-Vendor SaaS Ecosystem Introducing High Record Integrity and Interface Risk
A CRO operating SaaS eTMF and EDC systems with multiple IT service providers faces high record integrity risk and multi-vendor interface risk across regulated clinical investigations — with compliance obligations framed by FDA clinical electronic systems guidance and 21 CFR Part 11 where applicable.
High record integrity risk across eTMF and EDC platforms
Multi-vendor interface risk with fragmented IT service provider responsibilities
No formalised vendor oversight or documented SLA controls
E-signature and audit trail coverage inconsistent across systems
The Strategy
End-to-End Validation of Clinical Workflows with Vendor Oversight and Part 11 Controls
The validation scope covered electronic records, audit trails, user access, e-signature controls, outsourced provider controls, and data transfers between systems — validated against FDA clinical electronic systems guidance and Part 11 requirements to ensure the integrity and retrievability of clinical trial records.
Validate core workflows: document upload, versioning, approval, retrieval, and certified copies
Audit trail verification for all record modifications across eTMF and EDC
Vendor oversight: define responsibilities and verify IT service provider controls and SLAs
I’ve worked with many others and you’re way ahead of anything I’ve seen.
Pharma Manufacturing Client
The Solution
Compliant Clinical Record Ecosystem with Documented Vendor Accountability
The validated system ensures authenticity, integrity, and confidentiality of all clinical records, with audit trails and timestamps functioning as specified. All outsourced services operate under documented responsibilities and verified oversight mechanisms — meeting Part 11 and FDA clinical systems expectations at inspection.
System maintains authenticity, integrity, and confidentiality for all clinical records
Audit trails and timestamps verified to function as specified
Outsourced services governed by documented responsibilities and oversight mechanisms
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