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V5 Ultimate CAPA

V5 Ultimate CAPA is a corrective and preventive action module with structured workflows for root-cause analysis, action tracking, and closure.

Place
#8 of 23
Score
6.4
V5 Ultimate CAPA's website

What V5 Ultimate CAPA is

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 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.

Good

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

Watch out

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

Who it suits

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.

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.

Plans and prices

From V5 Ultimate CAPA's own pricing page, checked 2 Oct 2026.

All about pricing
PlanPriceWhat it gives you
Express$110 a monthconcurrent seat · annual billing saves 15% · per concurrent seat per month
Professional$160 a monthconcurrent seat · annual billing saves 15% · per concurrent seat per month
Enterprise$200 a monthconcurrent seat · annual billing saves 15% · per concurrent seat per month

The facts

Each one read from V5 Ultimate CAPA's own pages, with the date it was checked.

What it does

Audit trail
Regulated record writes and signatures are stored in an immutable audit table containing the operator, timestamp, IP, reason and before/after hash.checked 2 Oct 2026
CAPA lifecycle
V5 provides structured root-cause workflows, corrective and preventive actions, scheduled effectiveness checks, closure lineage, hash-chained records and signed closure.checked 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.checked 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.checked 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.checked 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.checked 2 Oct 2026
Integrations
V5 provides signed webhooks, a JSON REST interface and CSV bulk import, with integrations including NetSuite, SAP Business One, Microsoft Dynamics, QuickBooks, Xero, LabWare, STARLIMS, Empower, ShipStation, Power BI, Tableau, Snowflake, Okta, Azure AD, Slack and Teams.checked 2 Oct 2026
Regulatory coverage
The CAPA module is modeled against 21 CFR Part 820.100, ICH Q10/Q9 and ISO 13485:2016 requirements.checked 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.checked 2 Oct 2026
Support
The support agreement provides 24/7/365 Severity 1 support with a two-hour human initial response.checked 2 Oct 2026

Where it runs

Platform scope
V5 combines MES, WMS and QMS on one immutable batch record.checked 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.checked 2 Oct 2026

Money

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.checked 2 Oct 2026

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