Veröffentlicht am: 29.01.2010
Pumacy to develop KMmaster® Life Science Edition to strengthen quality assurance in pharmaceutical and biotech industry
Pumacy Technologies AG, a leading provider of knowledge, process and innovation management solutions today announced the development of the KMmaster® Life Science Edition (http://www.intakt-lifesciences.de/)as part of the EU-funded project BIOsecure. The software solution will meet the needs of the pharmaceutical and biotech industry for quality assurance. Based on the knowledge management platform KMmaster® the Life Science Edition will provide a security architecture that supports quality processes in accordance with the principles of good laboratory practice (GLP) for computer-aided systems.
BIOsecure aims at the development of a security architecture including an electronic signature and a concept that provides efficient long-term retention of knowledge from quality processes in accordance with the principles of GLP. This concept is especially important for biotech businesses that need to control and manage their standard operating procedures (SOP).
“The security architecture with an integrated electronic signature for GLP compliant processes provides a forward-looking framework for a complete electronic SOP management in accordance with the stringent international regulatory guidelines,” said Dr. Lars Langenberg, Chief Technical Officer of Pumacy Technologies AG.
Particular effort was made by Pumacy to recruit and train specialists who will be able to provide support to biotech businesses. The software pilot of the KMmaster® Life Science Edition for the SOP management already provides basic features such trainings management, 21 CFR Part 11 compliance and integrated audit trails. The successful implementation of the security architecture is seen as a basic cornerstone for the later integration of additional GLP conform modules (such as materials, tools, qualification of staff etc.) and the support of other quality processes in accordance to GxP.
KMmaster (http://www.kmmaster.de) is a product of the Pumacy Group, appropriate for different knowledge management applications. Individually implemented solution concepts support the integration of KMmaster into different PLM environments to develop, collect, share, store, apply and evaluate knowledge. The KMmaster technology structures working methods and improves business processes.
Das Projekt BIOsecure der Pumacy Technologies AG wird von der Europäischen Union und dem Land Berlin kofinanziert (Europäischer Fonds für regionale Entwicklung). Investition in Ihre Zukunft!