Pharma, biotech, and medtech PMOs run projects under a level of scrutiny generic PM tools were never built for. ProjectVue's Validation tier structures your project lifecycle around GAMP 5, keeps a 21 CFR Part 11 audit trail, and supports electronic sign-off — built into the workflow, not bolted on after.
Project phases map directly to the GAMP 5 (2022) lifecycle stages — not the outdated IQ/OQ/PQ terminology still floating around older validation templates.
| Stage | What Happens Here |
|---|---|
| 01 · Planning | Scope, risk assessment, and validation approach defined up front. |
| 02 · Requirements | User and functional requirements captured and traced. |
| 03 · Design | System and configuration design specified against requirements. |
| 04 · Build & Configure | System built or configured per the design specification. |
| 05 · Testing | Verification testing executed with full traceability back to requirements. |
| 06 · Release & Deployment | System released to production with documented sign-off. |
| 07 · Periodic Review | Ongoing review to confirm the system remains in a validated state. |
Every requirement traced to design, test coverage, and result — visible in one matrix, ready for an auditor to review.
Every change logged with who, what, and when — timestamped and attributable, not editable after the fact.
Sign-off workflows structured to support Part 11 electronic signature requirements at each lifecycle gate.
Log and classify deviations by impact, distinguishing test-execution-sourced findings from manually logged ones.
A dedicated role for reviewing and approving validation artifacts, separate from standard project permissions.
Export traceability matrices and audit logs in the format an inspector expects to see.
Built for teams running computer system validation, quality-relevant projects, or any initiative that needs to hold up under a regulatory audit — without the overhead of a dedicated validation platform.
See the Validation tier in your own portfolio.