Successful Re-Certification in accordance with DIN EN ISO 9001:2000| Successful Re-Certification in accordance with DIN EN ISO 9001:2000 |
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24 June 2008
in accordance with DIN EN ISO 9001:2000. TÜV Nord certifies and confirms the consistent and compliant implementation of Systec & Services’ internal Quality Management System and utilization in all business units. The audit report has been issued without any deviations or additional recommendations. Systec & Services has once again received the confirmation for their internal Quality Management System and the strict implementation in all business units. Above and beyond the actual quality guidelines, Systec & Services is the first systems provider to implement the guidelines, processes, templates and procedures also as part of an IT system – the so-called eQCM – and has rolled out that solution company wide. Thereby all QM processes such as change control, CAPA, deviation management and research and development (R&D) activities are controlled by the electronic workflows of the eQCM and provide the basis for the pre-validated System SYPROS™, an MES system developed on the basis of SAP Netweaver and MII. With that, Systec & Services does not only adhere to the quality guidelines for all development activities but furthermore provides an off-the-shelve validation package, which is available along with SYPROS™. Not only for the internal activities but also for all of Systec & Services GMP-IT hardware components as well as for all the customer projects in the business units Software and Services, eQCM controls the processes and ensures the quality of the systems before, during but more importantly after the delivery to the customer. “Computer System Validation (CSV) is carried out in accordance with national and international guidelines such as GAMP 5. With eQCM we can accomplish our validation activities most efficiently and perform audits spontaneously“, comments Markus Roemer, responsible for the Quality Management and the business unit Compliance Management at Systec & Services. „This has been confirmed to us numerous times as part of both customer audits and now also by TÜV Nord“. The system is very flexible, so flexible that it was possible to implement modifications and enhancements within less than 2 weeks, which were a result of the new GAMP 5 guidelines published by the ISPE February this year. Systec & Services once again defines its leadership in the industry and is well prepared for the future – already today! For further Information: Systec & Services GmbH Public Relations |
Karlsruhe, 23th June 2008 – Today, Systec & Services GmbH has received the Certificate of the Re-Certification of their Quality Management System