Straight answers to procurement questions.

The integration uses OPC-UA via FactoryTalk Linx Gateway as the primary path, with direct EtherNet/IP to ControlLogix and CompactLogix where the customer prefers a thinner stack.

• Phase, unit and batch status read into V5 work-order context; deviations on the floor link back to the offending phase.
• FactoryTalk Historian backfilled into the eBR on batch close (OPC-HDA or REST).
• FactoryTalk View SE/ME alarms ingested into V5 deviation queues with operator acknowledgement.
• Studio 5000 (.L5X) tag database imported as the binding source for prompt-to-tag mapping — no hand-keying.

V5 sits at ISA-95 Level 3 next to Proficy, not on top of it. Job intake comes from Proficy Plant Applications (or upstream ERP), status updates flow back, and historian data is pulled into the batch record at close.

• Production-order / job intake via Proficy Plant Apps REST or SQL view — V5 acknowledges, executes, returns final status.
• iFIX and CIMPLICITY SCADA tags consumed via OPC-UA for in-process capture and interlocks.
• Proficy Historian queried via REST or OPC-HDA at batch close; series stored alongside operator-captured data in the BMR.
• Alarm/event hand-off into V5 deviations with bidirectional acknowledgement.

Yes. Execution-time events (deviations, OOS, NCRs) open in V5 because that's where they happen on the floor, then graduate to Veeva Vault QMS (or MasterControl, TrackWise, ETQ) for investigation, CAPA, and management review.

• Deviation / NCR records pushed via Vault QMS REST API with attachments (batch record extract, photos, signed e-records).
• CAPA status returned to V5 so the linked deviation closes when the CAPA closes — audit-trailed both sides.
• Approval round-trip: Vault e-signatures recognised as Part 11 / Annex 11 compliant, hash recorded against the V5 event.
• Same interface pattern available for MasterControl, Sparta TrackWise, ETQ Reliance, Qualio.

Support is provided by our own engineers under the severity framework in MSA Section 11.

• Hosted Severity 1 (production down): initial human response within 1 business hour under the current MSA §11.3(c); On-Premises Severity 1: 2 business hours (§11.2).
• Every customer gets a named contact and a documented escalation path.
• Uptime, backup, recovery and breach-notice answers are in the Security & Trust reference (v5ultimate.com/security#procurement).

Lead site builds the template library. Follow-on sites inherit by default and only diverge where the equipment or master data genuinely differs. Later sites usually reuse more, but effort depends on each site's scope.

• Templated and inherited: recipes, in-process control checks, role definitions, e-signature gates, report layouts, label templates, integration mappings, validation package (IQ/OQ scripts), training matrix.
• Site-specific: equipment binding (PLC tags, scale IDs, printer queues), master data references (SAP plant code, storage locations), local SOP attachments, language packs.
• Governance: corporate-level template owner approves changes; local sites can extend but not break the corporate baseline. All diffs audit-trailed.
• Timeline: set per site in your Order or statement of work after a scoping review; we do not quote a standard duration.

If the source system exposes the change (OPC-UA tag, alarm, audit event), V5 captures it contemporaneously and ties it to the active batch step. The auditor sees the operator action, the machine response, and the timestamp in the same row of the BMR.

• Setpoint changes (e.g. mixer RPM, jacket temperature) logged with old value, new value, operator ID, timestamp.
• Control-loop excursions auto-create a deviation linked to the batch step — no operator can close the step until reviewed.
• Alarm acknowledgements from FactoryTalk / iFIX / CIMPLICITY appear in the audit trail with the acknowledging operator.
• Final BMR section 'In-process automated events' renders these alongside operator-captured data, one chronological view.

Single PDF per batch, deterministic layout, every signature with cryptographic hash, every data point with its source (operator / instrument / PLC tag / connected system). Retrievable in two clicks from any approved role.

• Sections: header & status, materials consumed (with lot/serial), in-process checks, automated events, deviations & dispositions, e-signatures, attachments index.
• Retrieval: QA opens batch number → 'Generate / View BMR' → PDF rendered. Inspector walkthrough mode highlights anomalies first.
• Hash chain: every signature recorded with SHA-256 hash of the signed payload; tamper evidence stitched into the audit trail.
• Available for inspector hand-off as PDF, signed PDF/A, or read-only portal link with watermark.

Hosted (V5 Ultimate Cloud) is the default and fastest path to validated production. Private Cloud is also hosted and operated by us, with an isolated application and database. On-Premises — your datacentre or a cloud account you control — is supported when local policy requires. The application is identical; only operational responsibility shifts.

• Hosted: V5 manages infrastructure, OS, database, backups, DR, patching, OS-level monitoring. Customer manages user accounts, business configuration, recipe approval. V5 provides IQ/OQ artefacts; customer executes PQ.
• Private Cloud: hosted and operated by us on the same platform as Cloud, with your own isolated application instance and database (MSA §2.4). A cloud account you own is an On-Premises deployment, not Private Cloud.
• On-prem: customer owns and operates everything below the application; V5 provides installation IQ, application OQ scripts, and supports customer PQ execution.
• Same upgrade cadence across all three; on-prem customers pin to LTS releases (annual major, quarterly minor).

Which SAP objects are connected, and how, depends on your landscape and is agreed in your Order or statement of work. Under the current Commercial Terms your team owns the integration design, mappings and testing; S.G. Systems delivers only the items expressly agreed. The list below shows the kinds of data buyers usually ask about.

V5 leans hard on the customer's existing teams once a week, not full-time. The biggest dependency is master-data quality and named owners on each side.

• OT/automation: named contact for PLC tag mapping; access to FactoryTalk / Proficy gateway; standard read-only OPC account.
• IT: SSO (Azure AD / Okta) tenancy and SAML/OIDC config; network path to ERP and historian; egress allow-list for hosted deployments.
• QA: validation lead to review IQ/OQ deliverables and execute PQ; recipe owner to sign off template library.
• SAP/ERP: BTP iFlow developer or basis admin for 2–3 working sessions over the pilot; service user with the standard authorisations.
• Site operations: line lead + 2 operator champions for kiosk UX walkthroughs and training.
• Master data: a clean cut of items, BOMs, routings, and active recipes before configuration freeze.

Both. V5 reads SAP Process Orders, Production Orders, or its own internally-created Work Orders interchangeably. Operators see the same kiosk regardless of the source — the order type is metadata, not a different workflow.

• SAP-driven plants: production-order intake is the default; V5 acknowledges, executes, returns final status and posts goods movements.
• Standalone V5 plants: native work orders cover unplanned rework, sampling runs, and pilot batches.
• Mixed estates: both can coexist in the same site; the order ID prefix denotes source.

First-class workflow. The operator picks from an approved substitution list (defined per BOM line by the recipe owner); the choice is signed, audit-trailed, and propagated into the consumption posting and the BMR.

• Substitution rules defined at recipe template level: allowed alternates, conversion factor, allergen / regulatory cross-checks.
• Operator UX: kiosk surfaces the primary material; if unavailable, the alternate list is one tap away with reason capture.
• Approval gate: substitutions outside the pre-approved list trigger a supervisor / QA e-signature before the step closes.
• Downstream: SAP goods movement posts against the actual material consumed; cost variance auto-attributed to the substitution event.

Cost scales with line count and recipe complexity, not seat count. Use the public band estimator on /pricing as a starting point; for a multi-site programme we run a free landscape workshop that produces a per-site cost band within two weeks.

• Lead-site: scoped on lines, recipe count, integration count, and validation depth (GxP vs non-GxP).
• Mixed-equipment sites: cost driver is the number of distinct equipment classes, not the number of physical lines.
• Output of the workshop: a 5-year TCO model with low/base/high bands, broken down by site and by year, suitable for capex/opex submission.

Role-based access with strict segregation of duties — template author cannot approve their own template, scheduler cannot release a batch, operator cannot disposition a deviation. Fully configurable; the defaults below pass FDA and EU GMP inspection out of the box.

• Template author — drafts recipes, label templates, e-form layouts.
• Template approver — reviews and signs off template versions; cannot also be author of the same version.
• Scheduler / planner — releases orders to the floor; cannot author or approve templates.
• Operator — executes steps at the kiosk; cannot disposition deviations or release batches.
• Supervisor — approves substitutions, overrides, and signs supervisor gates.
• QA reviewer — reviews completed BMRs, dispositions deviations.
• QA releaser — issues batch release; cannot also be reviewer of the same batch.
• System admin — manages users, roles, integrations; cannot execute production roles in the same environment.
• All roles SSO-provisioned (SCIM); training-matrix-gated — the kiosk blocks an operator without current training on the active recipe.

Yes. V5 ships native electronic logbooks for cleaning (with hold-time and dirty-equipment tracking) and calibration (with due-date interlocks). When a piece of equipment is overdue, the kiosk blocks the operator from binding it to an active batch step.

• Cleaning logbook: cycle type, agent, contact time, post-clean verification, operator e-signature, hold-time clock with expiry alert.
• Calibration logbook: instrument ID, due date, as-found / as-left, technician signature, certificate attachment, automated lockout on overdue.
• Kiosk interlock: scanning an instrument barcode with an overdue cert prevents step completion and prompts re-calibration workflow.
• Optional CMMS integration: bidirectional sync with IBM Maximo, SAP PM, or Fiix when the customer wants the CMMS to remain the master.