Straight answers to buying questions.

V5 Ultimate is shop-floor execution and quality software for regulated manufacturers. It brings manufacturing execution, warehouse and inventory, and quality management (MES, WMS and QMS) together, so production steps, lots, quality events and electronic signatures are recorded in one system as people work, with an immutable audit trail.

Both. V5 includes MES (work orders, production instructions, dispensing, equipment), WMS (receiving, putaway, picking, counting, shipping) and QMS (deviations, CAPA, change control, audits, documents and training) in one system, so quality events link to the batches, lots and steps they concern and share one audit trail.

Agentic AI is software that plans and executes multi-step work on its own — reading a deviation, pulling the related records, drafting the investigation. In regulated manufacturing its autonomy has a hard stop: anything that changes the quality record or releases product still requires a human decision and e-signature.

In V5, AI can read photographed paper batch records and map values back onto the master record for review, extract data from supplier labels, CoAs and delivery notes, help draft deviation investigations, and write a daily brief of what happened and what needs attention. People review and approve what the AI produces. AI demand and yield forecasting and process anomaly detection are coming soon.

AI in quality management software helps people draft and summarise inside the quality record. In V5 that includes classifying deviations, suggesting CAPA, drafting investigations, grouping complaints by likely root cause, building supplier scorecards and explaining the audit trail in plain English. An authorised person reviews the output before it is relied on.

In V5's lab workflows, AI can extract specification values from supplier CoAs and other documents into the QC record for review. Lab work itself — sampling, results, OOS investigation and stability schedules — runs through V5's lab and QC records with people reviewing and signing results.

A CRM built around the manufacturing sales cycle. V5's CRM tracks prospects, RFQs, samples and quotes, and links them to orders and production. Where AI connections are configured, AI can help draft messages and summaries for people to review. AI demand forecasting is coming soon.

Recalculating weigh-up targets from the actual assay or moisture (LOD) of a specific lot instead of the label claim. If an API lot assays at 98.2%, V5 adjusts the dispense quantity so the batch hits the labelled strength — with the lab value, the math and the operator's confirmation all written into the batch record.

Software alone can't make a company Part 11 compliant, but V5 provides the technical controls: identity-verified e-signatures on gated steps, an immutable audit trail with hash-chained record versions, role-based access and signed PDF renderings of batch records. The Part 11 assessment page summarises an independent assessment of V5 Ultimate 5.10 by Dr R.D. (Bob) McDowall (approved 25 September 2026), which reports the technical controls as compliant for manufacturing automation; QMS and QC modules were outside its scope. Your own procedures and validation are still required.

V5 provides controls that support what EU inspectors look for under Annex 11 — support for validating the computerised system, risk-based change control, periodic review, incident management, and a full audit trail. Validation artefacts (URS, FS, IQ/OQ templates) are included for Enterprise tier customers.

FSMA Section 204 led to FDA's Food Traceability Rule (21 CFR Part 1, Subpart S), which requires records of Key Data Elements at Critical Tracking Events for foods on the Food Traceability List. The original compliance date was 20 January 2026; FDA has proposed moving it to 20 July 2028, and Congress has directed FDA not to enforce the rule before that date. Records must be provided within 24 hours of an FDA request, or a reasonable time FDA agrees to. V5 captures KDEs at receiving, transformation and shipping and can export them as a sortable spreadsheet.

ISO 13485:2016 is the international quality management system standard for medical devices, and since 2 February 2026 FDA's Quality Management System Regulation incorporates it by reference into 21 CFR 820. It covers document and record control, training, design controls, CAPA, supplier controls and risk management. V5 supports these in execution — training checks on steps, change control routed through approval, and records protected by an audit trail. Certification is held by the manufacturer, not by software.

Not by itself, provided the AI never signs. Part 11 requires an identifiable person to apply each electronic signature. In V5, AI can draft deviation investigations, suggest CAPA and summarise records, but an authorised person reviews the output before relying on it, and signatures and approvals stay with people through V5's existing controls.

AI can help draft one: in V5, Quality AI can classify a deviation, suggest a CAPA and draft the investigation from the record. It cannot approve one. Root cause, actions, effectiveness and closure are decided and signed by authorised people through your configured CAPA workflow.

An electronic Device History Record (eDHR) is the electronic production record for a medical device, lot or batch — materials, operators, equipment, in-process checks, UDI and signatures. The former DHR section, 21 CFR 820.184, was removed when FDA's Quality Management System Regulation took effect on 2 February 2026; Part 820 now incorporates ISO 13485:2016, which still expects production records for each device or batch. V5 assembles the record as operators work.

A BMR is the live, signed reproduction of an approved Master Manufacturing Record for one specific batch, required under 21 CFR 211.188. It captures every weighment, in-process check, deviation and signature in sequence so QA can release the batch from a single immutable document.

A Unique Device Identifier (UDI) is a code issued under an FDA-accredited issuing agency's system (GS1, HIBCC or ICCBBA) that combines a Device Identifier (DI) with Production Identifiers such as lot, serial number or expiry date. FDA's UDI Rule (21 CFR Part 830 and the labeling rules in Part 801) requires it on labels and packages in plain-text and machine-readable (AIDC) form, and labelers submit DI data to GUDID. V5 prints UDI labels at the workstation and records them in the device history.

V5 includes industry packs for regulated manufacturers including pharmaceuticals, medical devices, dietary supplements, food processing, meat, bakery, ingredients and dry mixes, produce packing, cosmetics, cannabis, pet food, veterinary pharma, plastics and resins, agricultural chemicals, radiopharmaceuticals, chemicals, blood and tissue, and consumer products. Packs adjust terminology, screens and reports. The industries directory also lists further markets with guidance pages; ask which pack fits yours.

V5's pet food industry pack supports the production records pet food makers keep: formulas, ingredient lots, process and quality checks, lab results, labels and lot traceability, alongside hazard analysis and preventive-control records under FSMA's animal food rule (21 CFR Part 507). Whether guaranteed-analysis or nutrient-profile checks and label verification are set up for your products is confirmed during scoping; your team remains responsible for label claims.

V5 has a cannabis industry pack that records lots from intake through processing, packing and shipping. Connection to state tracking systems such as Metrc is set up with your team for your state and licence; which events are exchanged, and how, is confirmed during scoping. Ask us about BioTrack or other state systems before you buy.

V5 supports allergen control with allergen information on ingredients and formulas, an allergen control option in production settings, line-clearance and cleaning checklists linked to products, and a 'Contains' allergen statement built from the ingredients on the label preview. How sequencing, cleaning verification and label release are enforced depends on how you configure your workflows; your food safety plan defines the controls.

Both. V5 Ultimate runs as a hosted service operated by us (Cloud, or Private Cloud with an isolated application and database), or as V5 Ultimate On-Premises — a containerised, air-gap capable deployment in your own environment, where you own the database and encryption keys. The application code is the same; hosting responsibility and key custody differ. Hosting details are in the Security & Trust reference.

Yes, as the host. The V5 application tier runs as Linux containers, so on Windows Server it runs inside a Linux VM (Ubuntu 22.04 or RHEL 9) under Hyper-V. Sites that standardise on VMware, Nutanix or Proxmox instead run the same Linux VM on those hypervisors. For regulated (GxP) sites this Linux-VM pattern is the one the shipped IQ/OQ pack covers. Docker Desktop is not an option on Windows Server: Docker does not support Docker Desktop on Windows Server editions, including 2019 and 2022. Docker supports Docker Desktop (with WSL2) on client Windows 10 and 11 only.

Only relevant at regulated (GxP) sites. The Enterprise IQ/OQ package covers the Linux-VM pattern — a Linux guest on Windows Server Hyper-V, or on VMware, Nutanix or Proxmox hosts — at no extra cost. Docker Desktop is not an alternative on Windows Server — Docker does not support Docker Desktop on server editions of Windows — so validating any other stack for a regulated site would be scoped separately. Non-regulated plants don't need an IQ/OQ pack — pick whichever option fits IT.

No. The V5 application ships as Linux OCI container images — there is no Windows-native binary of the app tier. On Windows Server it runs inside a Linux guest VM on a Windows hypervisor such as Hyper-V. Docker Desktop is not an alternative there, because Docker does not support it on Windows Server editions; on client Windows 10/11, Docker Desktop uses WSL2 to run Linux containers. Postgres, by contrast, can run natively on Windows Server as the database tier.

It depends on scope: the number of sites, lines and products, how much master data needs loading, any ERP integration and, at regulated sites, your validation approach. A small single-site start with one industry pack and few integrations moves fastest. Your timeline and deliverables are set in your Order or Statement of Work; Enterprise IQ/OQ and validation support are scoped in your quote. We don't publish a standard duration because it depends on your plan and resources.

Standard tablets, panel PCs or computers with a current browser, barcode or DataMatrix scanners, label printers (for example Zebra ZPL), and network connections to scales and equipment where you want readings captured. V5 has no proprietary hardware; confirm your specific devices during scoping.

V5 is validatable, not validated for your use. Enterprise includes IQ/OQ and validation support — URS, FS, configuration spec, IQ/OQ protocols, traceability matrix and periodic-review templates, scoped in your quote. Your team runs intended-use testing and PQ and approves the validation report.

V5 is a connected, browser-based system, so plan for network outages as part of your site design. We don't publish an offline duration or replay guarantee here. Ask us which workstation actions are supported during an outage for your deployment, and test it against your site's outage tolerance and procedures before go-live. On-premises deployment keeps the application on your own network.

EMEA and EU deployments run on servers in the Netherlands; deployments for the rest of the world run in Oregon, United States. The locations of your database, files and recovery copies are confirmed for your deployment. On-premises customers keep data on their own infrastructure. Encryption commitments for hosted services are in the Commercial Terms, and per-layer detail is available on request.

You do. Under the Commercial Terms (section 12.3) and the EULA (section 6.1) you keep ownership of your Customer Data, including batch records, audit trail entries and electronic signature records. Standard export methods are supported during the subscription (section 12.5), and for hosted deployments your data is retrievable on request for 90 days after termination (section 5.4). On-premises data stays in your environment. S.G. Systems does not use Customer Data to train AI models (EULA section 6.1).

No. AI features run on the standard cloud service and are not a separate per-seat charge. Private Cloud (an isolated application and database) and on-premises deployment are options when you need more control, for example over release timing for validation. Ask which AI features are available in on-premises deployments.

The same way you validate any V5 feature: run the approved version, use Enterprise IQ/OQ support, run your own intended-use testing and PQ, and treat AI output as draft-until-signed. Private Cloud customers can defer routine feature releases for up to 180 days after notice to validate them; security fixes and legal requirements can require earlier updates, and longer extensions are agreed in writing.

No. V5 extends your ERP — it owns shop-floor execution, quality and the production record; your ERP keeps owning financials, procurement and the general ledger. V5 includes an ERP bridge with guided mapping for common ERPs. Which system owns each record, and any integration deliverables, are agreed in your Order or Statement of Work.

V5 can work alongside SAP. Its ERP bridge maps records such as materials, BOMs, orders and inventory movements between the systems. Which interfaces are used, which records flow in each direction and how often, and who builds and maintains them depend on your SAP landscape and are set out in your Order or Statement of Work. Some workflows may need custom fields or extensions in SAP.

V5 can work alongside NetSuite and Dynamics 365 through its ERP bridge, mapping records such as items, BOMs, work orders and inventory movements. The interfaces, direction and frequency of sync, reconciliation approach and who builds and maintains the integration are agreed in your Order or Statement of Work; some workflows need custom fields or extensions in the ERP.

Yes, where devices expose a supported interface. V5's guided device pairing covers scales, printers, sensors and PLCs using protocols such as Mettler Toledo SICS, Modbus TCP, OPC-UA and MQTT, with a live test of incoming readings, so values are captured into the record instead of transcribed. Confirm your specific scales and equipment during scoping.

V5 has three tiers, priced per concurrent seat per month: Express $110 and Professional $160, with a lower monthly rate when billed annually (about 15% less). Enterprise has a guide price of $200 per concurrent seat per month and is confirmed in your quote. Seats are counted by concurrent use, not per named user or per site. Current prices are on the pricing page.

V5 charges per concurrent seat, not per named user or per site. Any authorised user can use a seat, but only the purchased number of users can be signed in at the same time. Express is $110 and Professional $160 per concurrent seat per month; Enterprise is quoted, with a guide price of $200.

Yes. A 7-day free trial is available with no credit card required. Paid plans are priced per concurrent seat across three tiers: Express and Professional at published prices, and Enterprise by quote.

MasterControl is best known for quality and document management software — SOPs, change control and CAPA — and also offers manufacturing products. V5 is execution-first: it runs the floor and records each action against the procedure in one batch record. V5 can run alongside an existing document system, or hold documents itself; compare current capabilities with each vendor.

Tulip is a low-code app builder for operations — you build your own apps. V5 ships preconfigured for your industry with regulator-specific records, e-signatures and audit trail. Tulip suits teams that want to build their own apps; V5 suits teams that want regulated records configured from the start.

Veeva Vault is widely used for document and quality management in life sciences. V5 focuses on shop-floor execution and the live batch record. The two overlap on some QMS workflows, and V5 can run alongside Vault for document control; confirm integration scope for your Vault configuration.

Yes — that is a primary use case. V5 replaces paper batch and device history records with electronic records completed as operators work: steps follow the approved production instructions, data is captured at the step rather than transcribed later, and records use Part 11 e-signature controls and can be produced as PDF reports. Your team configures and validates the workflows for your intended use.