V5 Ultimate CAPA

Plans and prices

Every plan, in full

On the record

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 · read 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 · read 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 · read 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 · read 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 · read 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 · read 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 · read 2 Oct 2026

Platform scope

V5 combines MES, WMS and QMS on one immutable batch record.v5ultimate.com · read 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 · read 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 · read 2 Oct 2026

Support

The support agreement provides 24/7/365 Severity 1 support with a two-hour human initial response.v5ultimate.com · read 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 · read 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 · read 2 Oct 2026

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