Quality means reliability – which comes first in the production of medical equipment. As there are lives depending on their products, medical engineering companies are subject to high liability claims. Computer-aided quality management systems (QMS) can help in complying with international legislation and quality-related guidelines. Thus they provide for reliability in processes and products.
The advantages of computer-aided QMS are: continuous improvement of products, efficient and cost-oriented production processes as well as reliable documentation in case of liability claims. Most importantly such a system ensures that electronic records and electronic signatures can be considered to be trustworthy and equivalent to paper records. Thus a QMS efficiently supports the conversion to a paperless documentation of quality-related processes in compliance with standards and laws – all the while remaining user-friendly, customizable and future-proof.
German software developer Babtec Informationssysteme GmbH, since 1999 supplying medical engineering companies (among others) with QMS solutions, has committed itself to these 3 traits. Babtec's production-floor solutions encompass the advance planning of quality-related processes, quality assurance and project quality management.
A user-friendly QMS makes it easy for all employees to accept it into their daily routine. The Babtec solutions for instance use Web technology to enable all caseworkers to participate in quality-related processes – simply by using their Web browsers.
A customizable software solution can help in ensuring reliable processes throughout the company. In order to adapt to various business requirements as well as the medical industry's demands, Babtec QMS solutions follow a modular concept. Yet the customizable system shows its true worth on the small scale: with its user-specific authorizations, Babtec's software user administration creates unique and secure roles for any participating caseworker. There are also unique access authorizations as for instance required by electronic signatures.
As it is being continuously developed further, a future-proof software solution maintains any company's competitive edge. The innovative Babtec solutions always keep their updatability – regardless of any company-specific customizations. It is also important that Babtec's QMS software is compliant with standards (e.g. with DIN ISO 13485) as well as with international laws (FDA 21 CFR Part 11, EU Annex 11).