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V5 Ultimate CAPA

v5ultimate.com

From $110/mo Free trial WebWindowsLinuxAPISelf-hosted
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Spec score 7.7 #10 of 23 in Corrective and Preventive Action Software

What it is

V5 Ultimate CAPA manages corrective and preventive actions through structured root-cause workflows, scheduled effectiveness checks, and signed closure. Teams can use 5-whys, fishbone (Ishikawa), or Pareto methods. The module is modeled against 21 CFR Part 820.100, ICH Q10/Q9, and ISO 13485:2016 requirements, and connects CAPA work with V5’s MES, WMS, and QMS on one immutable batch record. Regulated writes and signatures enter an immutable audit table with the operator, timestamp, IP, reason, and before-and-after hash. V5 offers signed webhooks, a JSON REST interface, and CSV bulk import, with integrations including SAP Business One, NetSuite, LabWare, Power BI, and others. Deployment options are Lovable Cloud or containerized on-premises hosting that can operate air-gapped. The app tier runs in Linux OCI containers, not as a native Windows application. A free seven-day trial includes a non-GxP sandbox with sample data. Express costs $110 a month per concurrent seat; Professional is 160.00 USD and Enterprise 200.00 USD on the same basis. Annual billing saves 15%.

Spec sheet

Deployment
V5 is available on Lovable Cloud or as a containerized, air-gap-capable on-premises deployment with customer-owned database and encryption keys.Read 2 Oct 2026 · v5ultimate.com
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.Read 2 Oct 2026 · v5ultimate.com
Support
The support agreement provides 24/7/365 Severity 1 support with a two-hour human initial response.Read 2 Oct 2026 · v5ultimate.com
Audit trail
Regulated record writes and signatures are stored in an immutable audit table containing the operator, timestamp, IP, reason and before/after hash.Read 2 Oct 2026 · v5ultimate.com
CAPA lifecycle
V5 provides structured root-cause workflows, corrective and preventive actions, scheduled effectiveness checks, closure lineage, hash-chained records and signed closure.Read 2 Oct 2026 · v5ultimate.com
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.Read 2 Oct 2026 · v5ultimate.com
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.Read 2 Oct 2026 · v5ultimate.com
Identity and access
V5 supports SAML 2.0 single sign-on, SCIM 2.0 provisioning, role-based access control and tenant row-level security.Read 2 Oct 2026 · v5ultimate.com
Platform scope
V5 combines MES, WMS and QMS on one immutable batch record.Read 2 Oct 2026 · v5ultimate.com
Regulatory coverage
The CAPA module is modeled against 21 CFR Part 820.100, ICH Q10/Q9 and ISO 13485:2016 requirements.Read 2 Oct 2026 · v5ultimate.com
Security encryption
The service uses TLS 1.2 or higher in transit and AES-256 encryption at rest for databases, file storage and backups.Read 2 Oct 2026 · v5ultimate.com
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.Read 2 Oct 2026 · v5ultimate.com
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.Read 2 Oct 2026 · v5ultimate.com

Plans and prices

Express $110 a month per concurrent seat per month concurrent seat · annual billing saves 15% Read 2 Oct 2026 · v5ultimate.com
Professional $160 a month per concurrent seat per month concurrent seat · annual billing saves 15% Read 2 Oct 2026 · v5ultimate.com
Enterprise $200 a month per concurrent seat per month concurrent seat · annual billing saves 15% Read 2 Oct 2026 · v5ultimate.com

Every V5 Ultimate CAPA plan and price →

Strong points and limits

Strong points

  • Structured root-cause methods include 5-whys, fishbone, and Pareto.
  • Scheduled effectiveness checks and signed closure are supported.
  • Immutable audit records include operator, timestamp, IP, and reason.
  • Offers cloud and air-gap-capable on-premises deployment.
  • Free seven-day trial includes a sample-data sandbox.

Limits

  • No formal certifications are held today.
  • No Windows-native application binary is available.
  • No free plan is offered.
  • Plans start at $110 seat per month.

Who it suits

It suits regulated teams that need documented CAPA workflows, effectiveness checks, and signed closure tied to batch records. Organizations can choose cloud or air-gap-capable on-premises deployment, but Windows users need a Linux container environment.

Verdict

V5 Ultimate CAPA specifies its workflows, record controls, integration options, and deployment choices in detail. The Linux-container requirement and lack of formal certifications are important considerations alongside its per-seat monthly pricing.

Where Specifiction places it

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