By the numbers
Figures about V5, each with its definition.
What V5 covers and how it is scoped. Every figure sits next to a definition, so it can't be misread when it's quoted.
Platform coverage
Compliance
AI in the platform
Deployment & hosting
Integration footprint
What V5 covers.
- 18
- Each pack sets up industry vocabulary and starting record templates. How strictly steps are enforced depends on how your team configures and validates it. Source
- 35
- The 18 industry packs plus 17 more markets with their own pages and guides. A directory market is not a separate preset; fit is confirmed during scoping. Source
- 81
- A count of the distinct regulations and standards these pages refer to for context. It is not a claim that V5 maps or enforces each one; your procedures and validation determine compliance. Source
- 44
- One question per page, reviewed against the current product reference, trust reference and commercial terms. Source
Records and validation.
- Part 11
- Signatures are tied to named users, and records keep an audit trail of changes. Which steps require a signature is set in your configuration; you validate it for your intended use. Source
- Audit trail
- Changes to records are logged with who, what and when. Ask for the audit-trail scope for your deployment during evaluation.
- 24h
- When FDA requests traceability records, covered firms must provide them within 24 hours (or a reasonable time FDA agrees to), and an electronic sortable spreadsheet when FDA requests one to help address a public-health threat, subject to the rule's exemptions. V5 stores lot codes and Critical Tracking Events so that export can be prepared. Source
- GAMP 5
- IQ/OQ and validation support: URS, FS, configuration spec, IQ/OQ protocols, traceability matrix and periodic-review templates, scoped in the quote. Your team runs PQ and approves its validation. Source
What the AI actually does.
- Drafts
- AI suggests, drafts and explains within the signed-in person's role and workspace. Demand and yield forecasting and process anomaly detection are coming soon, not available today. Source
- Human
- AI output is never an e-signature, approval, lot release or validation evidence. People review, correct, sign and release. Source
Deployment and hosting.
- Scoped
- There is no standard number of weeks. The timeline depends on sites, lines, integrations and validation, and is set in your Order or Statement of Work. Source
- On request
- Encryption details for each hosting layer are in a controlled document shared on request, usually under NDA. Source
- Netherlands · Oregon
- The application runs in the Netherlands and Oregon (United States), with traffic shared between them. The database remains in Oregon, United States. Database, file and backup locations are listed per layer on the Security page and confirmed for your deployment. Source
What V5 plugs into.
- ERP bridge
- A guided bridge with field mapping and a dry run before go-live. Which systems, objects and directions are connected is agreed in your Order; there is no blanket list of certified connectors. Source
- OPC-UA · MQTT · Modbus TCP
- Scales, printers, sensors and PLCs can be paired with a live ingest test. Which signals reach which records is set up for your equipment. Source
- Scoped
- Label data such as UDI and GS1 codes can be recorded. Connections to registries or state systems such as Metrc are scoped per customer and state. Source
Quote any figure with the definition next to it.
These are platform-capability figures, not customer-specific telemetry. They describe what V5 Ultimate covers and how it is scoped; counts come from the site itself and other facts from reviewed sources. If you're writing about V5, cite the figure and the one-line meaning together so the number can't be stretched.
