XML specialist presents a new business solution / SCHEMA ST4 now with built-in documentation templates with ValiManager according to machinery directive Wiesbaden. The SCHEMA GmbH introduces two new products at the tekom annual Conference 2010. This is one of the ValiManager a solution validation documentation, especially for the pharmaceutical industry and medical technology. It is based on the editorial and content-management-system SCHEMA ST4 and was developed jointly with the HEITEC AG. Still, the XML specialist demonstrates the advantages of documentation templates now included in SCHEMA ST4 of SYSTEC GmbH according to machinery directive. SCHEMA will be Hall 1 found in the Rhine-Main-Hallen in Wiesbaden at the stand of 114. The tekom annual Conference will take place from 3 to 5 November in Wiesbaden, Germany.
The situation in the pharmaceutical and medical technology is complex: different laws, standards and guidelines must be respected. The responsibility lies with the operators: with him, the competent authorities and bodies check whether validation was properly implemented. The required large documents can be created (partially) automated. This support scheme with the help of a content management system, newly developed in collaboration with HEITEC AG ValiManagers. The ValiManager is based on SCHEMA ST4 and allows to create the process qualification and validation documents in high-quality, to manage and to generate.
First, the specification content from databases or structured lists are adopted or created manually. The structuring and standardizing the content achieves a high degree of reusability. The extensive linking of the content allow the detection of patency (traceability). The creation of content and layout are clearly separated. By the individual functions, the editors save time and improves the quality of the documentation. The system is flexible, that the scope of the documentation, the validation depth, the definition of each step and each common terms are adapted individually to the needs of the company can.