1Where each sits.
ISA-95, also known as IEC 62264, models how a manufacturer connects its business systems to its control systems, in levels. Level 4, business planning and logistics, “describes all the activities related to running a business” and includes ERP. Level 3, manufacturing operations management, covers manufacturing execution systems and other systems, such as SCADA, that manage manufacturing operations. Below them, Level 2 is the PLCs and distributed control systems that monitor and supervise the process, Level 1 the sensors, valves and other devices that sense or affect production, and Level 0 the physical process.¹ The standard deals mainly with the interface between Levels 3 and 4: the information that passes between the plant and the business.¹²
FDA’s computer software assurance guidance for medical device manufacturers, issued on 3 February 2026, uses both as examples. An ERP feature “automates material ordering and delivery to appropriate production operations”. An MES “may be used to manage workflow, track progress, record data, and establish alerts or thresholds based on validated parameters”.³
2What each holds in GMP terms.
The drug CGMP regulations do not mention either system. They require records, and read against the ISA-95 levels, the activity each record describes falls at Level 3, Level 4 or both.⁴¹
| Record | What it must show | Kind of activity |
|---|---|---|
| Master production and control record (211.186) | The components and their quantities, theoretical yield and limits, and complete manufacturing and control instructions | Manufacturing operations, Level 3 |
| Batch production and control record (211.188) | Each significant step: dates, major equipment, component lots, weights and measures, in-process and laboratory results, yield, and who performed and checked each step | Manufacturing operations, Level 3 |
| Component records (211.184) | Each shipment and lot received with its supplier, test results, an inventory record for each component and a reconciliation of each lot’s use | Both: receipt and stock, and use in each batch |
| Distribution records (211.196, 211.150) | Product, consignee, date, quantity and lot shipped, and a system to find where each lot went if it must be recalled | Business logistics, Level 4 |
When an MES creates the batch record, that record has to document each significant step at the time of performance, and a step performed by automated equipment must still identify the person who checked it.⁴ The EU’s batch processing record asks for the same kinds of information, including the times of significant stages and signed authorisation for any deviation from the processing instructions.⁵ The quality control unit then reviews and approves all production and control records before release, and any unexplained discrepancy, including a yield outside the limits in the master record, must be investigated.⁴
3Where the two meet.
Material moves across the boundary, and its status has to mean the same thing on both sides. Components are held in quarantine until tested and released, each lot is withheld from use until the quality control unit releases it, and drug products are quarantined before release. When a component is dispensed, a second person, or one person checking automated equipment, confirms that it was released by the quality control unit.⁴ So whichever system shows stock as available, that status has to follow the quality control unit’s decision.
The data passing between ERP and MES is GMP data when it carries those statuses, lots or quantities. Annex 11 says systems exchanging data electronically should include “appropriate built-in checks for the correct and secure entry and processing of data”,⁶ and 211.68(b) requires input to and output from a computer system to be checked for accuracy, with the degree and frequency of checking based on the system’s complexity and reliability.⁷ FDA lists “electronic materials management system records” among the records whose changes should be restricted to authorised personnel.⁸ ISA-95 Parts 2 and 5 define the interface content and business-
4How validation differs.
FDA asks for each CGMP workflow on a computer system to be validated, and uses an MES to explain why: qualifying the MES platform “does not demonstrate that a given MPCR generated by the MES contains the correct calculations”. Where one system performs both CGMP and non-CGMP functions, the potential for the non-CGMP functions to affect CGMP operations should be assessed and mitigated.⁸
For medical devices, FDA’s assurance guidance sets the effort by risk. Software for general business processes, “such as email or accounting applications”, is generally not part of production or the quality system. An ERP restocking feature where a qualified person checks materials before use is an intermediate risk, but the same feature becomes high risk if it also automates the material check with no person checking. For change reporting, an MES that manages workflow and records data is treated differently from one that automatically controls and adjusts critical production parameters such as temperature, pressure or process time.³ The guidance is written for device manufacturers; Annex 11 asks drug manufacturers for the same kind of judgement, basing the extent of validation on “a justified and documented risk assessment”.⁶
5How it runs in Seal.
Seal’s MES runs batch workflows configured around your process, with material eligibility, equipment readiness, operator instructions, QC and review in the same workflow. The operator scans each lot, the workflow checks its identity, status and expiry, and the quantity is recorded against the configured tolerance; the accepted dispense is the source for inventory reconciliation and batch genealogy. Where an ERP stays in place, Seal connects to it for orders, materials and lots, and each connection sets which system owns which record.
The ERP integrations read selected records from SAP S/4HANA Cloud and NetSuite, which stay the source of truth. The bills of materials guide keeps BOM revisions, required quantities and recorded consumption distinct, and shows how to reconcile a consumption posting whose acknowledgement from the ERP is lost.
References
- 1ISA-95 Series of Standards: Enterprise-Control System Integration, International Society of Automation, including ANSI/
ISA- 95. 00. 01- 2025, Part 1: Models and Terminology. https:/ / www. isa. org/ standards- and- publications/ isa- standards/ isa- 95- standard (read 6 November 2026) - 2IEC 62264-1:2013, Enterprise-control system integration, Part 1: Models and terminology, ISO. https:/
/ www. iso. org/ standard/ 57308. html (read 6 November 2026) - 3Computer Software Assurance for Production and Quality Management System Software, Guidance for Industry and FDA Staff, FDA, 3 February 2026, sections V.A.1 to V.A.3. https:/
/ www. fda. gov/ media/ 188844/ download (read 6 November 2026) - 421 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, sections 211.82, 211.84, 211.100, 211.101, 211.142, 211.150, 211.184, 211.186, 211.188, 211.192 and 211.196, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211 (read 6 November 2026) - 5EudraLex Volume 4, Chapter 4: Documentation, European Commission, in operation from 30 June 2011, section 4.20. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ chapter4_ 01- 2011_ en_ 0. pdf (read 6 November 2026) - 6EudraLex Volume 4, Annex 11: Computerised Systems, European Commission, in operation from 30 June 2011, sections 1 and 5. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ annex11_ 01- 2011_ en_ 0. pdf (read 6 November 2026) - 721 CFR 211.68, Automatic, mechanical, and electronic equipment, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 211. 68 (read 6 November 2026) - 8Data Integrity and Compliance With Drug CGMP: Questions and Answers, Guidance for Industry, FDA, December 2018, questions 3 and 4. https:/
/ www. fda. gov/ media/ 119267/ download (read 6 November 2026)
AQuestions and answers
Can an ERP replace an MES in a GMP plant?
An ERP can hold orders, stock and distribution records, but the batch production record has to document each significant step at the time it is done, with who performed and checked it. If an ERP module captures those entries, it is doing the MES’s job and must be validated for that use, workflow by workflow.
Does the ERP need to be validated?
The parts that create or hold GMP records, or that decide whether material can be used, do. FDA’s device guidance treats software for general business processes, such as accounting, as generally outside production and the quality system, and an automated material check with no person checking it as high risk. FDA’s drug data integrity guidance expects you to assess whether non-CGMP functions in the same system could affect CGMP operations.
Who owns material status, the ERP or quality?
Quality. Under CGMP, components and products stay in quarantine until the quality control unit releases them, and dispensing checks that each component was released. Any system that shows material as available should carry the status the quality control unit set, through an interface that is checked for accuracy.
What is the difference between an MES and an electronic batch record?
The electronic batch record is the record itself: the batch production record kept electronically. The MES is the system that runs production and creates that record as the work happens, checking materials, equipment and the sequence of steps along the way.
Where does SCADA fit between MES and ERP?
ISA-95 places SCADA at Level 3 with the MES, as systems that manage manufacturing operations. PLCs and distributed control systems that monitor and supervise the process sit at Level 2, and ERP sits at Level 4 with the business.