The 2026 Compliance Feature Checklist

RFP language around compliance often sounds definitive while leaving room for costly interpretation. Requirements like “21 CFR Part 11 compliant” or “supports electronic signatures” only matter when the underlying controls are defined, tested, and documented. Without that clarity, teams move forward on assumptions and discover gaps late—during validation, audits, or go‑live. This checklist translates regulatory expectations into concrete, testable criteria across six critical areas. It details the technical controls that must be present, the demo scenarios that prove they work in practice, and precise language you can reuse to eliminate ambiguity in future RFPs. The result is a practical way to separate substantiated compliance from marketing claims, reduce validation rework, and keep IT and Quality aligned from vendor selection onward.
Gain insight into how to use it to make compliance verifiable before contracts are signed.
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