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MRP and ERP Systems
Material Requirements Planning and Enterprise Resource Planning systems that orchestrate MedTech production and supply chain.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
MRP/ERP systems connect demand forecasting, BOM explosion, supplier scheduling, inventory, lot/serial tracking, and quality holds. In regulated environments they require formal computer system validation. Validation follows a risk-based approach, and FDA's 2025 Computer Software Assurance guidance for production and quality system software encourages focusing testing on features that affect product quality. ERP systems that hold quality records need Part 11 controls such as audit trails and electronic signatures. Lot holds and quarantine status in ERP help prevent release of nonconforming product. What the regulation says
Under FDA 21 CFR Part 820.70(i), automated processes, including Manufacturing Resource Planning (MRP) and Enterprise Resource Planning (ERP) systems, must be validated for their intended use. Similarly, ISO 13485:2016 clause 4.1.6 requires validation of computer software used in the quality management system. The EU MDR (Regulation (EU) 2017/745) Annex I, General Safety and Performance Requirements, also implicitly requires control over manufacturing processes, which includes the software systems managing them.What this means in practice
ERP changes (upgrades, configurations) are a frequent source of unexpected QMS impact - change control needs to include the ERP layer explicitly.Examples
- A MedTech company implements a new ERP module for inventory management; this module must be validated to ensure accurate tracking of components, preventing use of expired or non-conforming materials.
- During an FDA inspection, a manufacturer must provide documented evidence of the validation for their MRP system, demonstrating its ability to correctly manage the Bill of Materials and production orders.
- An ERP system upgrade changes how lot numbers are assigned; the change control process mandates re-validation of this specific functionality to ensure continued compliance with traceability requirements.
Common pitfalls
- •A common pitfall is treating an ERP system solely as an IT tool, overlooking its critical role in controlling production and quality processes.
- •Failing to involve quality assurance personnel in all stages of ERP system validation and change control can lead to non-compliant operations.
- •Not adequately documenting the validation of each ERP module or configuration change can result in audit findings.
- •Underestimating the impact of ERP system upgrades on existing validated processes and their associated risks is a frequent mistake.
- •Over-reliance on vendor validation data without performing adequate in-house verification specific to the MedTech manufacturer's intended use is a significant oversight.
Frequently asked questions
The primary concern is ensuring that these systems, when used to control or monitor manufacturing processes and quality records, are validated to demonstrate they consistently produce accurate and reliable results, as required by regulations like FDA 21 CFR Part 820.70(i).
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Cited by
Where this term appears across MedTech Terms.
Ecosystems (1)
Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 1Tier 4Trade press and expert commentary· 1
Link health: 3 verified· last checked 2026-06-20
ISPE·1FDA·1ISO·1
- 1GAMP 5Tier 4 VerifiedISPEispe.org
- 2FDA - Device ManufacturingTier 2 VerifiedFDAfda.gov
- 3ISO 13485 Standard PageTier 1 VerifiedISOiso.org
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