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V5 Ultimate CAPA

C
C tier on Corrective and Preventive Action SoftwareScore 6.3 · #7 of 23
Android app
Not listed
Free plan
Trial only
Paid plans from
$110/mo
Runs on
api, Linux, self-hosted, Web, Windows
v5ultimate.com
The V5 Ultimate CAPA homepage
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Summary

V5 Ultimate CAPA is a corrective and preventive action module with structured workflows for root-cause analysis, action tracking, and closure. It supports scheduled effectiveness checks, closure lineage, hash-chained records, and signed closure, with 5-whys, fishbone, and Pareto methods. The module is modeled against 21 CFR Part 820.100, ICH Q10/Q9, and ISO 13485:2016 requirements. V5 combines MES, WMS, and QMS on one immutable batch record, with signed webhooks, a JSON REST interface, and CSV bulk import. Deployment is available through Lovable Cloud or as a containerized on-premises option designed to support air gaps. The vendor offers a free seven-day trial with sample data in a non-GxP sandbox. Express costs 110.00 USD per concurrent seat per month, Professional 160.00 USD, and Enterprise 200.00 USD; annual billing saves 15%. The app tier runs as Linux OCI containers, so there is no Windows-native application binary.

Who it is for

V5 Ultimate CAPA suits organizations seeking structured CAPA workflows and an immutable batch record spanning MES, WMS, and QMS. Its Linux-container deployment may suit teams able to run the app tier in a Linux environment.

What is good

  • Scheduled effectiveness checks
  • Supports electronic signatures and signed closure
  • Free seven-day trial with sample data
  • Air-gap-capable on-premises deployment

What to know first

  • No Windows-native application binary
  • Plans are priced per concurrent seat
  • Vendor says it has no formal certifications today

Verdict

V5 Ultimate CAPA combines structured corrective-action workflows with audit-oriented records and multiple deployment options. Review the Linux app-tier requirement and certification status alongside the trial and per-seat pricing.

V5 Ultimate CAPA plans and pricing

All plans
Express $110/mo per concurrent seat per month concurrent seat · annual billing saves 15% v5ultimate.com · 2 Oct 2026
Professional $160/mo per concurrent seat per month concurrent seat · annual billing saves 15% v5ultimate.com · 2 Oct 2026
Enterprise $200/mo per concurrent seat per month concurrent seat · annual billing saves 15% v5ultimate.com · 2 Oct 2026

Compared on corrective and preventive action software

Free plan
Nov5ultimate.com
Root-cause methods
5-whys, fishbone (Ishikawa), Paretov5ultimate.com
Effectiveness checks
Yesv5ultimate.com
Electronic signatures
Yesv5ultimate.com
Audit trail
Yesv5ultimate.com
Mobile access
Yesv5ultimate.com

Facts

CAPA lifecycle
V5 provides structured root-cause workflows, corrective and preventive actions, scheduled effectiveness checks, closure lineage, hash-chained records and signed closure.v5ultimate.com · 2 Oct 2026
Regulatory coverage
The CAPA module is modeled against 21 CFR Part 820.100, ICH Q10/Q9 and ISO 13485:2016 requirements.v5ultimate.com · 2 Oct 2026
Platform scope
V5 combines MES, WMS and QMS on one immutable batch record.v5ultimate.com · 2 Oct 2026
Security encryption
The service uses TLS 1.2 or higher in transit and AES-256 encryption at rest for databases, file storage and backups.v5ultimate.com · 2 Oct 2026
Identity and access
V5 supports SAML 2.0 single sign-on, SCIM 2.0 provisioning, role-based access control and tenant row-level security.v5ultimate.com · 2 Oct 2026
Compliance assessment
V5 Ultimate 5.10 was independently assessed as compliant with 21 CFR Part 11 technical controls by Dr Bob McDowall in September 2026.v5ultimate.com · 2 Oct 2026
Deployment
V5 is available on Lovable Cloud or as a containerized, air-gap-capable on-premises deployment with customer-owned database and encryption keys.v5ultimate.com · 2 Oct 2026
Windows limitation
There is no Windows-native application binary; the app tier runs as Linux OCI containers, including through a Linux VM or Docker Desktop with WSL2 on Windows Server.v5ultimate.com · 2 Oct 2026
Trial and onboarding
The vendor offers a free seven-day trial without a credit card or sales call and provides a non-GxP sandbox with sample data and an audit trail.v5ultimate.com · 2 Oct 2026
Support
The support agreement provides 24/7/365 Severity 1 support with a two-hour human initial response.v5ultimate.com · 2 Oct 2026
Certification status
V5 states that it does not hold formal certifications today and lists SOC 2 Type II and ISO 27001 milestones as future plans.v5ultimate.com · 2 Oct 2026

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