“Using GAMP 5 for Rapid Deployment” – a new article published in the ISPE Pharmaceutical Engineering| “Using GAMP 5 for Rapid Deployment” – a new article published in the ISPE Pharmaceutical Engineering |
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31 March 2009
In the article, Markus Roemer and Hermann Schäfer describe risk-based software development methods and software release management concepts. It also discusses implementation of quality planning, aspects of compliance management and practical implementation of the ISPE GAMP®5 guidelines in terms of the Systec & Services development of SYPROS – a solution based on SAP NetWeaver and MII. “Using GAMP 5 for Rapid Deployment" describes the software development practices from the perspective of Systec & Services, thus from the developer’s point of view. Systec & Services' software products are designed, developed, validated and implemented primarily for regulated industries and the development and project methods used are oriented towards this. The article at hand describes risk-based methods and their application to product development. How can the GAMP®5 guidelines take into account release management as well as quality planning and compliance concepts generally, even in the design phase? Systec & Services has always aimed to develop pre-validated and pre-configured solutions for regulated industries especially for software solutions being utilized in production and as a result need to comply with validation requirements for GxP conform manufacturing. “We have already presented these methods multiple times in customer audits and during inspections and put them to the test," mentions Markus Roemer, who is the Director of Compliance Management at Systec & Services. “Our customers and regulatory agencies have confirmed us numerous times that our compliance practices are at the highest level." Along with considering the technical aspects, the article also delivers information on technological requirements from the software user’s point of view. The search for the best solution for a company is usually based on how well it meets the functional requirements. This often results in a diversified IT landscape composed of completely different solutions from various suppliers on separate platforms and unique technologies also referred to as “best of breed” solution. But from the point of view of the end user and their organization, the best solution would probably be ONE single software solution that meets all requirements and is based on a harmonized technology and IT platform - what you would call a "best-of-class" solution. Systec & Services offers MES solutions for the pharmaceutical, food, cosmetics and chemical industries which are based on and fully integrated with SAP. “The technological advancements are constantly moving forward so much that solutions that would not have been possible years ago are now conceivable," comments Hermann Schaefer, Managing Director of Systec & Services and responsible for the product suite SYPROS, among other areas. “Corporate software today is not only purely functional; it increasingly offers integration platforms and development frameworks. In other words, this is the ideal basis for companies like ours to offer complementary solutions that do not just integrate, but are rather more or less a part of the bigger solution.” We hope you enjoy reading the whole article. If you have any questions on it or would like additional information or advice, Mr. Roemer and Mr. Schaefer look forward to hearing from you. Markus Roemer Hermann Schäfer Here you can read the article: |
Karlsruhe, 31th March 2009 – You can read the article “Using GAMP 5 for Rapid Deployment” in the latest issue of the ISPE Pharmaceutical Engineering magazine.