--- title: "MRP / ERP, MRP and ERP Systems | MedTech Terms" description: "Material Requirements Planning and Enterprise Resource Planning systems that orchestrate MedTech production and supply chain." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mrp-erp#term", "name": "MRP and ERP Systems", "alternateName": "MRP / ERP", "description": "MRP/ERP systems connect demand forecasting, BOM explosion, supplier scheduling, inventory, lot/serial tracking, and quality holds. 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The extent of re-validation depends on the risk associated with the change." } }, { "@type": "Question", "name": "Can cloud-based MRP/ERP systems be used in MedTech?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, cloud-based MRP/ERP systems can be used, but they require the same rigorous validation as on-premise systems. Manufacturers must also ensure data integrity, security, and traceability in accordance with regulatory requirements and maintain appropriate vendor qualification processes." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Manufacturing](/terms?cat=Manufacturing) 6. / 7. MRP and ERP Systems [All terms](/terms) Manufacturing [Manufacturing & Supply](/ecosystems/manufacturing-supply)MRP / ERP # 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 Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition MRP/ERP systems connect demand forecasting, [BOM](/terms/bom) explosion, supplier scheduling, inventory, lot/serial tracking, and quality holds. In regulated environments they require formal computer system validation. 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](/terms/intended-use). Similarly, [ISO 13485](/terms/iso-13485):2016 clause 4.1.6 requires validation of computer software used in the quality management system. The EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) Annex I, [General Safety and Performance Requirements](/terms/gspr), 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](/terms/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 What is the primary regulatory concern with MRP/ERP systems in MedTech? 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). How often do MRP/ERP systems need to be re-validated? Can cloud-based MRP/ERP systems be used in MedTech? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Manufacturing Lot Traceability Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number. ](/terms/lot-traceability)[ Manufacturing Supplier Controls Procedures to ensure purchased products and services conform to requirements. ](/terms/supplier-controls) ### More in Manufacturing · Same category [ Manufacturing Bill of Materials(BOM) Structured list of every component, sub-assembly, and quantity needed to manufacture a device. ](/terms/bom)[ Manufacturing Bioburden Quantification of viable microorganisms on or in a product before sterilization. ](/terms/bioburden)[ Manufacturing Cleanroom Classes (ISO 14644) ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9). ](/terms/cleanroom-iso-14644)[ Manufacturing Container Closure Integrity(CCI) Demonstration that a sterile package maintains microbial barrier and contents integrity over the labeled shelf life. ](/terms/container-closure) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Manufacturing & Supply](/ecosystems/manufacturing-supply) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISPE· 1 FDA· 1 ISO· 1 1. [1 GAMP 5 Verified ISPE · ispe.org ](https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition) 2. [2 FDA - Device Manufacturing Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices) 3. [3 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Production controls for connected devices? We help device manufacturers operationalize cybersecurity in design transfer, production, and supplier controls. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Manufacturing Acronym MRP / ERP Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=mrp-erp) Learn in 60 seconds Card Lesson Quiz Material Requirements Planning and Enterprise Resource Planning systems that orchestrate MedTech production and supply chain. - · ERP changes (upgrades, configurations) are a frequent source of unexpected QMS impact - change control needs to include the ERP layer explicitly. - · In regulated environments they require formal computer system validation. Remember this Watch out: A common pitfall is treating an ERP system solely as an IT tool, overlooking its critical role in controlling production and quality processes. Related terms - [Lot Traceability ](/terms/lot-traceability) - [Supplier Controls ](/terms/supplier-controls) You may also need Auto-suggested from Manufacturing and shared keywords. - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Counterfeit Parts and Suspect Components ](/terms/counterfeit-parts) - [Scrap Rate and Yield ](/terms/scrap-yield) - [ISO/IEC 27001(ISO 27001) ](/terms/iso-27001) - [Device Master Record(DMR) ](/terms/dmr) - [Engineering Change Order / Notice(ECO / ECN) ](/terms/eco-ecn) [All Manufacturing terms](/terms?cat=Manufacturing) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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