DMS-based solution on the basis of SAP ERP, SAP QM and SAP PLM

Manufacturers of medical products are subject to particularly strict rules, whether from health authorities such as the FDA in the USA, international standards bodies such as the ISO, or national legislators. Correspondingly, the documentation and burden of proof concerning the product composition, product development, and quality management are very extensive. To be able to comply with these obligations more easily, efficiently and securely, was the great wish of a leading international medical technology manufacturer for injection systems.

Integrated document management as underlying concept

The burden of proof of compliance required by the authorities is document-centered. For this reason, an integrated DMS solution seemed to be a sustainable approach from the manufacturer’s point of view. For this purpose, the engineering systems were to be seamlessly linked to SAP ERP, SAP QM, and SAP PLM – with the following effects:

  • All product-related data and documents are stored in the SAP system
  • Product creation process and product lifecycle can be completely mapped
  • QM tasks can be dovetailed directly with release and change processes
  • Product files can be assembled reliably as well as with time and cost efficiency
The cherry on the cake: Engineering Control Center

To implement all this, the company chose ECTR. The DSC software integrates all kinds of authoring in SAP PLM: from MCAD/ECAD to MS Office. ECTR also offers a “sexy” desktop, as the customer noticed. More precisely: an intuitive SAP cockpit with all relevant functions for editing master, structure and document metadata. This makes it possible to structure and manage data and documents very easily, and classify them and link them to any SAP objects. Change management is also nice and easy, as is the maintenance of metadata, the creation of material masters, equipment, and functional locations as well as the derivation of BOMs from the CAD structure.

No release without design control

Conscientious design control is the basic prerequisite for getting medical products safely through authorization and audit. Thanks to the new solution, verification and validation are now a fixed component in the digital release process. That means that a developed product is not released until it fulfills the required product properties and its specified usage aims can therefore be reached effectively, efficiently, and satisfactorily. The checked, rule-conform design data provides a solid basis for consistent compliance – right up to the finished product.

DMR/DHR management – a simple task

The prescribed device master records (DMR) must contain specific documents. Thanks to the integrated solution, these records can be derived automatically from the structure and configuration of the released product. They are managed on the ECTR desktop. Here, every product has a DMR folder with different sub-folders: from requirements to product specifications, material master and BOM, as well as from manufacturing specifications and standard work plans to QA/QC procedures and inspection plan, packaging and labeling, plus installation and maintenance. The device history records (DHR) are also automatically created together with everything else that is relevant – derived from the transaction data and ERP reports in the SAP system.

Reliable audit trail – fully automatic

Into the bargain, the integrated solution also makes for a secure and transparent audit trail. In particular thanks to the close, validated system (specified, tested, documented) that covers everything: product data and document management, process definition and control, as well as user and rights management. This makes interdependencies transparent and workflows automatable. Critical transactions can be monitored, audit-relevant events retraced, and system accesses documented. Thanks to digital signatures, every check made and every authorization can also be verifiably documented: whether with a view to documents, material releases, production batches subject to submission requirements or many other factors besides. A welcome side-effect of the digital signature: audit- and authorization-relevant documents can be submitted to external inspection bodies electronically.

Success achieved – together with DSC

The successful implementation can also be put down to the intelligent and flexible ECTR software, as well as the comprehensive project support given by DSC. In accordance with the identified requirements, the integration specialists came up with and put into practice an all-round secure and efficient solution. They were able to put this into operation rapidly, and it has proved itself in day-to-day practice.

FDA audits easily mastered

The first three comprehensive FDA inspections (level 2 audits) have already proved the effectiveness of the new solution – as regards compliance, quality assurance and quality control. Key results:

  • All audits successfully completed
  • No deficiencies or objections
  • Everything in accordance with design control and cGMP
  • QA/QC functioning on every company site

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Phone: +49 721 9774-100
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DSC Software AG
Am Sandfeld 17
76149 Karlsruhe | Germany

Phone: +49 721 9774-100
Fax: +49 721 9774-101