Freedom251 › Corrective and Preventive Action Software
V5 Ultimate CAPA
What V5 Ultimate CAPA is
V5 Ultimate CAPA is a corrective and preventive action module for structured root-cause workflows, action tracking, and closure. It supports 5-whys, fishbone (Ishikawa), and Pareto methods, along with scheduled effectiveness checks, closure lineage, hash-chained records, and signed closure. 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.
For data exchange, 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. Deployment is available through Lovable Cloud or as a containerized, air-gap-capable on-premises installation with customer-owned database and encryption keys. The vendor offers a free seven-day trial with sample data in a non-GxP sandbox. Plans are priced per concurrent seat per month, from 110.00 USD for Express to 200.00 USD for Enterprise; annual billing saves 15%.
Who it suits
V5 Ultimate CAPA suits organizations that need structured CAPA workflows, effectiveness checks, and signed closure records. Its deployment choices, integrations, and modeled regulatory requirements may fit teams working across quality, manufacturing, and warehouse systems.
What it does well
- Includes 5-whys, fishbone, and Pareto root-cause methods.
- Schedules effectiveness checks and supports signed closure.
- Combines MES, WMS, and QMS on one immutable batch record.
- Offers cloud and air-gap-capable on-premises deployment.
- Supports SAML 2.0, SCIM 2.0, and role-based access control.
What to know first
- No Windows-native application binary is available.
- No free plan is offered; the trial lasts seven days.
- The vendor says it does not hold formal certifications today.
Limits
The free trial lasts seven days. Paid plans are billed per concurrent seat per month: Express is 110.00 USD, Professional is 160.00 USD, and Enterprise is 200.00 USD; annual billing saves 15%. The app tier runs as Linux OCI containers, not as a Windows-native application binary.
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| Express | per concurrent seat per month · concurrent seat · annual billing saves 15% | $110 a month |
| Professional | per concurrent seat per month · concurrent seat · annual billing saves 15% | $160 a month |
| Enterprise | per concurrent seat per month · concurrent seat · annual billing saves 15% | $200 a month |
As v5ultimate.com lists them, read 2 Oct 2026. The maker's own page has the final word.
Getting started
- Open the V5 Ultimate CAPA website.
- Start the free seven-day trial; no credit card or sales call is required.
- Explore the non-GxP sandbox with sample data and an audit trail.
- Choose Lovable Cloud or a containerized on-premises deployment.
- Connect through a supported integration, signed webhook, JSON REST interface, or CSV bulk import.
Verdict
Choose V5 Ultimate CAPA if you need a structured CAPA module with effectiveness checks, signed closure, and cloud or on-premises deployment. Look elsewhere if a Windows-native application binary or current formal certifications are required.
Questions
How much does V5 Ultimate CAPA cost?
Express is $110 per concurrent seat per month, Professional is 160.00 USD, and Enterprise is 200.00 USD. Annual billing saves 15%.
Is there a free plan or trial?
There is no free plan. The vendor offers a free seven-day trial without a credit card or sales call, with a non-GxP sandbox and sample data.
Which platforms and deployment options are available?
V5 lists API, Linux, self-hosted, web, and Windows platforms. It is available through Lovable Cloud or as a containerized, air-gap-capable on-premises deployment; its app tier is not a Windows-native application binary.
Does V5 hold formal certifications?
V5 states it does not hold formal certifications today. SOC 2 Type II and ISO 27001 are listed as future plans.
Which integrations does it support?
Integrations include NetSuite, SAP Business One, Microsoft Dynamics, QuickBooks, Xero, LabWare, STARLIMS, Empower, ShipStation, Power BI, Tableau, Snowflake, Okta, Azure AD, Slack, and Teams. It also provides signed webhooks, a JSON REST interface, and CSV bulk import.
What security controls does it describe?
V5 uses TLS 1.2 or higher in transit and AES-256 encryption at rest. It also supports SAML 2.0 single sign-on, SCIM 2.0 provisioning, role-based access control, and tenant row-level security.
Facts from V5 Ultimate CAPA's own pages
- Audit trail
- Regulated record writes and signatures are stored in an immutable audit table containing the operator, timestamp, IP, reason and before/after hash. · v5ultimate.com, 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. · 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
- 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
- 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
- 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. · v5ultimate.com, 2 Oct 2026
- Platform scope
- V5 combines MES, WMS and QMS on one immutable batch record. · 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
- 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
- Support
- The support agreement provides 24/7/365 Severity 1 support with a two-hour human initial response. · 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
- 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