ISA-95 (S95) – Enterprise–Control IntegrationGlossary

ISA‑95 (S95) – Enterprise–Control Integration

Q: Is S95 just an IT model?

No. It defines the operational contract across ERP, MES, SCADA/HMI, WMS, and LIMS so QA can release based on evidence—not assurances.

Q: How does S95 relate to S88?

S88 structures procedural control inside equipment; S95 structures enterprise-to-operations integration (orders, resources, events). Use both in tandem.

Q: Where should labels get their data?

From the same governed master and execution records that feed the eBMR, with label verification and serialization to ensure parity.

Q: Can we run without MES if ERP is strong?

You can, but you lose governed recipes, device binding, and eBMR integrity. ERP↔PLC shortcuts create audit holes and scale badly.

Q: What if masters differ between ERP and MES?

Harmonize codes and UOM under MDM, lock interface mappings, and route edits via Change Control. Dual truth guarantees deviations.

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Enterprise–Control Models, Master Data & Interfaces, Audit‑Ready Integrations • Manufacturing, QA/RA, IT/OT

ISA‑95 (S95) standardizes how business intent becomes executed work and how executed work becomes trustworthy records. Practically, it defines the split between planning and execution, the objects that move (materials, equipment, personnel, segments), and the messages that prove what happened when. High‑function operations use S95 to bind MES/MOM, SCADA/HMI, WMS, LIMS, and ERP into clean interfaces with governed masters and an eBMR that stands up to inspection. Low‑function operations wire hope to spreadsheets, retype labels, and reconcile after the truck leaves.

“If ERP promises what MES can’t execute and SCADA can’t prove, you don’t have integration—you have theater.”

TL;DR: S95 is the contract between enterprise (planning) and operations (execution). Govern master data under Document Control, enforce UAM, and capture audit trails. Drive orders into device‑tight phases in MES, publish genealogy via EPCIS, and render labels from the same truth verified by Label Verification. Hold release in the eBMR until QA disposition. No shadow spreadsheets. No PLC‑to‑ERP backchannels. No anonymous overrides.

1) What S95 Covers—and What It Does Not

Covers: production operations (schedule, dispatch, track, report), quality, maintenance, inventory, and personnel modeling across Levels 2–4. It specifies objects and event flow so systems interoperate without bespoke point‑to‑point code. Does not cover: detailed control logic (that’s S88/PLC), nor does it excuse poor governance. S95 is architecture—execution still needs validated systems and disciplined operators.

2) Legal, System, and Data Integrity Anchors

Where production, labeling, or release are regulated, integrations and e‑records must meet Part 11/Annex 11: validated software under CSV/GAMP 5, unique users and roles (UAM), governed masters (Document Control), immutable audit trails, and controlled retention. If your data isn’t attributable and reconstructable, your architecture is decorative.

3) The Evidence Pack for S95 Integration

A defensible “S95 pack” shows: level maps and context diagrams; master data dictionaries (materials, equipment, personnel, segments); interface specs and mappings; error handling and retries; validation evidence (CSV/GAMP 5); audit trails for changes; and eBMR examples proving end‑to‑end: order → dispatch → consume/produce → labels → QA disposition. Include EPCIS event samples and genealogy reconstruction.

4) From Order to Release—A Standard Path

1) Plan & Stage. ERP issues orders; WMS stages lots under Hold/Release logic and FEFO/FIFO rules.
2) Dispatch & Execute. MES instantiates governed recipes; SCADA/HMI runs phases; devices are verified in status.
3) Assure Quality. Sampling/tests route to LIMS; exceptions open Deviation and close via CAPA.
4) Label & Release. Labels render from execution truth with Label Verification; QA reviews the eBMR and dispositions.

If prerequisites fail (stale masters, device out of status, blocked quality), stop the flow and remediate before proceeding. Integration must prevent bad work—not document it faster.

5) Designing the Integration—A Practical Method

Start with objects and events: (i) normalize identifiers and UOM; (ii) define work definitions and allocations; (iii) model event vocabulary (start, complete, consume, produce, hold, label); (iv) bind equipment eligibility and training prerequisites; (v) map error handling and retries; (vi) validate negative paths. Lock mappings under Document Control and route edits via Change Control. Re‑test when masters or interfaces change materially.

6) Measurement & Data Quality

Bad data breaks good architectures. Validate methods (TMV), quantify noise and bias (MSA), and enforce calibration status on sources. Treat label content, equipment IDs, and lot codes as data elements with owners and checks. Until inputs are clean, analytics and schedules are fiction.

7) Data Integrity—Proving Compliance Without Reconciliation

Every transaction must be attributable and replayable: who dispatched, who weighed, which device, which version, which label template, and why an override occurred. Keep arithmetic and logic inside validated systems; ban spreadsheet brokers. Store approvals and edits with audit trails; show linkage from ERP order to pallet SSCC in minutes—not days.

8) Scheduling, WMS & Lab Cross‑Checks

Use governed Production Scheduling with finite capacity and eligibility. WMS must stage correct lots and block putaway to incompatible zones. Cross‑check execution truth against LIMS results periodically; sustained deltas indicate mapping or data integrity faults that require immediate correction before release.

9) Equipment & System Status—Readiness and Drift

Integrations should hard‑block execution if devices are out of status, if required utilities or training are missing, or if versions conflict. Treat drift (e.g., repeated label mismatches or pick denials) as capability signals and investigate under RCA with corrective actions tracked to closure.

10) Labels, Claims & Master Data Alignment

Labels must consume the same truth used for execution: identity, lots, dates, hazards. Render from governed masters; verify prints with Label Verification; serialize units and logistics via Serialization/SSCC. Retyping is a recall in slow motion.

11) Warehouse Status & Logistics Units

The WMS enforces status, quarantine, and compatibility; publishes EPCIS events for moves, packs, and ships; and ties labels to SSCC and lots. Inventory remains on hold until QA confirms eBMR completeness and parity with labels. Shipments include hazard/ingredient claims when applicable.

12) SPC in Daily Control—Keeping Flow Predictable

Apply SPC to execution KPIs: schedule adherence, pick accuracy, label parity, test‑result turnaround. Use Cp/Cpk to quantify headroom to service levels and regulatory limits. Where integration performance creeps, tighten controls in MES/WMS and correct root causes—not dashboards.

13) Metrics That Demonstrate Control

Schedule Adherence (ERP plan → MES completion variance) by line and shift.
Label/Record Parity incidents and time‑to‑correction.
Right‑First‑Time and Release Lead Time (last execution event → QA disposition).
Pick/Stage Accuracy with quarantine/status violations caught by WMS.
Genealogy Response Time for mock recalls (EPCIS/eBMR drill).
Data‑Quality Blocks (MSA/TMV/calibration) that prevented bad execution.

These KPIs connect service and compliance to financial impact and operational levers (masters, mappings, training, device status).

14) Common Pitfalls & How to Avoid Them

PLC↔ERP shortcuts. Bypass MES governance and create audit holes.
Spreadsheet brokers. Manual mapping tables with no audit trail.
Dual masters. Different material codes/UOM across ERP/MES/WMS.
Retyped labels. A slow motion recall generator.
Anonymous overrides. No attribution, no defense at inspection.
“We’ll reconcile at release.” You’ll reconcile into scrap and CAPA debt.

15) What Belongs in the S95 Integration Record

Include level maps; master data definitions and owners; interface specs and mappings; scheduling rules; device eligibility and training prerequisites; exception handling; EPCIS event models; label templates and verification logic; eBMR exemplars; validation evidence; audit trails; and approvals/effective dates under Document Control. Retain per your retention schedule aligned to regulatory requirements and product life.

16) How This Fits with V5 by SG Systems Global

Governed Masters. The V5 platform carries materials, equipment, personnel, and segment definitions as versioned, effective‑dated objects with change reasons and approvals recorded in the audit trail. Recipes inherit these and deploy to execution with device binding.

Execution & Interlocks. V5 pushes orders into MES, enforces role/training gates, checks calibration status, and blocks work on stale masters. WMS staging and label print use the same truth.

Traceability & Evidence. V5 publishes EPCIS events and compiles the eBMR with signatures. Dashboards expose schedule adherence, parity incidents, and genealogy response; exceptions open Deviation and close via CAPA. Bottom line: V5 makes S95 boringly reliable—exactly the point.

17) FAQ

Q1. Is S95 just an IT model?
No. It’s an operational contract. It tells ERP what to send, MES what to execute, SCADA what to control, and WMS/LIMS what to prove—so QA can release on evidence, not assurances.

Q2. How does S95 relate to S88?
S88 structures how equipment runs (phases/equipment modules). S95 structures who/what/when/where at enterprise–operations boundaries. Use both: S88 inside units, S95 across systems.

Q3. Where should labels get their data?
From the same governed master and execution records feeding the eBMR. Verify prints with Label Verification and serialize units and pallets.

Q4. Can we run without MES if ERP is “strong”?
You can, but you’ll lack governed recipes, device binding, and eBMR integrity. Direct ERP↔PLC shortcuts fail audits and scale poorly. MES/MOM is the execution brain—use it.

Q5. What if masters differ between ERP and MES?
Treat it as a defect. Harmonize codes/UOM under MDM, lock mappings, and route edits via Change Control. Dual truth guarantees deviations.

Q6. How do we prove integration works?
Provide CSV/GAMP validation, interface test evidence (including negative paths), live eBMRs with audit trails, EPCIS genealogy drills, and metrics showing low parity incidents and fast recall response.