CSV · CSA · GAMP 5 · Part 11 · Annex 11
Validation management software built for risk-based CSA — not a documentation warehouse.
V5 Ultimate helps life-science sites manage Computer System Validation (CSV) and Computer Software Assurance (CSA) work: linked requirements, risks and test records, reviewed and approved by your team.
Risk-based test design (CSA)
Change control integration
Validation Summary Report (VSR)
Periodic review
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You need validation management software because CSV is drowning your team.
Every system change kicks off a 3-month revalidation nobody has time for
CSA promised risk-based testing — nothing in your toolchain enables it
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.
Risk-based test design (CSA)
Requirement-level risk scoring drives test intensity — unscripted, exploratory or fully scripted — as FDA CSA guidance intends.
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
- Audit trail and e-signature records your QA can review and export for an inspection
- Independent Part 11 assessment of V5 Ultimate 5.10 (Dr. Bob McDowall, Sept 2026)
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 — software controls that support your Annex 11 approach; validation and procedures remain yours.
Validation management software, answered.
What's the difference between CSV and CSA?
CSV (Computer System Validation) documents everything. CSA (Computer Software Assurance; FDA final guidance, February 2026) 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.
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.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
See V5 Ultimate (Validation Management) with your own process.
Free trial for evaluation. IQ/OQ and validation support are available with Enterprise.