EDC Validation & Comparison Pack
The documents your quality team keeps asking for — validation approach, traceability templates, security annex, and a straight-talking comparison against the big EDC suites. Built by people who've done computer-system validation for clinical trials.
- Phased 21 CFR Part 11 / GCP validation approach
- Requirements & traceability matrix template (CSV-ready)
- CSV & CDISC ODM export mapping sheet
- Security & infrastructure annex (GDPR / UK GDPR lenses)
- Side-by-side EDC comparison (Elysium vs Castor / Medrio / Medidata)
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Everything in the pack
Validation Plan Template
Phased validation approach mapped to 21 CFR Part 11 and ICH GCP: risk assessment, vendor and infrastructure qualification, testing levels, and traceability.
Traceability Matrix (CSV-ready)
User requirements to functional design to test script — with acceptance criteria columns you can drop straight into your system of record.
EDC Comparison Sheet
Feature-by-feature comparison of Elysium vs Castor, Medrio, OpenClinica and Medidata Rave, with pricing transparency notes.
Export Mapping Sheet
Field-by-field mapping of Elysium CSV and CDISC ODM outputs to your SDTM/SDTM-annotated CRF plan.
Security & Infrastructure Annex
Hosting, encryption, RBAC, audit logs, backup and business-continuity posture — written in language your InfoSec team can review quickly.
SOP & Test Script Checklist
A practical checklist for user acceptance testing, role provisioning, and migration cutover so you go live with everything covered.