Package Insert 41
Interesting facts and figures for customers and partners of mt-g.
June 2017
Guest Article
Cross-site software solution for process validation: Harmonised quality management for manufacturers of medical devices
The medical device market places high demands on producers in order to prevent health hazards among the users of the products. Manufacturers are therefore subject to mandatory validation in order to ensure applicable quality standards. The validation proves that the suitability of the respective product has been tested and confirmed for its intended purpose. It provides evidence that the specified requirements are met for the entire product life cycle.

Overall, validation in the manufacturing of medical devices is a complex, time-consuming, cost-intensive task – not only for the producers, but also for suppliers that have to meet specific requirements. Modern quality management software which is geared to GxP regulations, support the implementation of the rules. This includes, among other things, complex document management, audit-proof archiving and seamless tracking of all changes.

Cross-site solutions

"The support is even more efficient if the software offers the possibility of cross-site use," explains Dr Alexander Künzer Managing Director at ConSense GmbH. With the GxP version of its ConSense IMS|QMS|PMS software solution, the company has developed a fully supervised management system that supports compliance with the applicable national and international standards.

The cross-site use of the software benefits organisations that have extensive or transnational locations. This can simplify the standardisation of their quality management. The big challenge for international companies in this regard is to present all information – from individual documents to complete process descriptions – with a uniform structure and in all of the languages ​​that are used in the company. In doing so, country-specific deviations often have to be taken into account or specifications have to be implemented which are unknown in one's own country.

ConSense IMS|QMS|PMS|GxP illustrates these differences and all relevant information can be displayed and maintained throughout the group in a central database. At the same time, certain processes can be managed in sub-databases. This allows a "gentle" harmonisation of quality management across several sites or QM systems.

Efficient solution for manufacturers of medical devices

Companies in the medical device sector have to be able to rely on their suppliers and their quality assurance measures. Among other things, this is checked during supplier audits. The cross-site use of software simplifies quality assurance in this regard, as well. This makes it easier for suppliers, for example, to prepare their audits and helps them meet the requirements of the medical device manufacturer. "Innovative software solutions for quality management which, like ConSense IMS|QMS|PMS|GxP, are tailored to the most demanding GxP requirements make the complex procedures in medical device manufacturing more efficient," stressed Dr Alexander Künzer.

The cross-site use of ConSense IMS|QMS|PMS|GxP to manage training together with validations is also possible. In addition to this, there are also strict requirements for the manufacturing of medical devices in order to verify specific knowledge for the implementation of certain activities and processes.
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