Validation management software that CSA actually rewards — not a documentation warehouse.
V5 Ultimate manages Computer System Validation (CSV) and Computer Software Assurance (CSA) programs for FDA and EMA-regulated life-science sites. Traceable URS/FS/DS, risk-based test scripting, IQ/OQ/PQ execution, and signed validation summary reports — under GAMP 5 Second Edition and FDA's 2022 CSA guidance.
You need validation management software because CSV is drowning your team.
Validation packs live in Word/Excel across five shared drives — no traceability
Every system change kicks off a 3-month revalidation nobody has time for
CSA promised risk-based testing — nothing in your toolchain enables it
IQ/OQ/PQ evidence is manually assembled from screenshots for every audit
Requirements traceability breaks the moment a URS is updated
Your CSV team is a bottleneck for every new module the business wants
The CSV / CSA lifecycle, in one system.
URS / FS / DS traceability
Requirements linked to functional and design specs, then to test cases and executed scripts — automatic RTM at any point in time.
Risk-based test design (CSA)
Requirement-level risk scoring drives test intensity — unscripted, exploratory or fully scripted — as FDA CSA guidance intends.
IQ / OQ / PQ execution
Test scripts executed in-platform with e-signed evidence, screenshots and objective results — no separate testing tool.
Change control integration
Every change assesses validation impact, opens targeted retest, and re-signs only the affected requirements — not the whole system.
Validation Summary Report (VSR)
VSR assembles from the executed evidence — signed, timestamped and exportable as a Part 11-compliant record.
Periodic review
Scheduled periodic review with prompts for change history, incident summary, user access review and re-qualification decisions.
What CSV/CSA looks like when the software carries the work.
- Requirements-to-evidence traceability generated in seconds
- Change-driven retest scope shrunk 60–80% versus paper CSV
- Zero-finding CSV audits under FDA and MHRA inspection
- Independent GAMP 5 / Part 11 / Annex 11 assessment publishing Aug 2026
- Onboarding delivers V5's own validation pack — reviewed and countersigned by customer QA
The frameworks your CSV program is measured against.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — covered out of the box.
GAMP 5 Second Edition
Category 4 configured product with documented critical thinking. CSA-aligned test evidence delivered with onboarding — not a six-month after-the-fact project.
Validation management software, answered.
What's the difference between CSV and CSA?
CSV (Computer System Validation) documents everything. CSA (Computer Software Assurance, FDA 2022 draft guidance) applies critical thinking — validate more where patient risk is high, less where it's not. V5 supports both approaches; most customers move toward CSA once trust is established.
Do you replace tools like ValGenesis or Kneat?
For customers running V5, yes — the same platform managing production also manages its own validation. Standalone validation-management platforms are typically retired once V5 is in place because the source-of-truth data already lives here.
Can we validate our own custom configurations?
Yes. V5's validation module treats customer configurations as Cat 5 items when appropriate, with the test evidence and change-control history bound to the URS.
How does V5 handle change control against a validated baseline?
Every change opens an impact assessment against the RTM — only affected requirements retest, only affected signatures re-execute. The rest of the validated baseline stays intact.
Do you support periodic review?
Yes, scheduled per-system with prompts for incidents, change history, user-access review and re-qualification decisions — all signed and archived.
See a CSA-aligned validation pack built on your own requirements.
Free trial. Onboarding delivers V5's own IQ/OQ/PQ evidence.