Veröffentlicht am: 19.04.2010
BlisterCentrum Berlin-Brandenburg selects Pumacy Technologies’ KMmaster® Life Science Edition
KMmaster® Life Science Edition to improve quality assurance at BlisterCentrum Berlin-Brandenburg.
Pumacy Technologies AG today announced that the BlisterCentrum Berlin/Brandenburg (BCBB) has selected the KMmaster® Life Science Edition (www.intakt-lifesciences.de/) to create and manage standard operating procedures (SOP) with a web-based application offering key rolls, business processes as well as a trainings management.
KMmaster Life Science Edition enables the development and sharing of quality documents and knowledge and can be accessed from any workstation at the BCBB. Relevant stakeholders are integrated into the development process based on a FDA-compliant workflow. Employees, teams, the management as well as quality representatives are able to share knowledge and information. The creation, development and management of SOPs and the trainings management rationalise the controlling at the BCBB by a prioritisation of operations and notifications. The integrated audit trail ensures that the development process of any content may be tracked.
“We are a pharmaceutical company with manufacturing authorisation in accordance to article 13 of the German Pharmaceutical Act. Utmost priority is given to quality assurance. By using the KMmaster Life Science Edition we are able to manage our electronic documents from creation and review to the organisation of necessary training sessions. Our employees access the KMmaster via the intranet. The Life Science Edition facilitates routine work such as versioning, linkage and the organisation of training schedules. Formal errors can be avoided,” explains Christian Buttenberg, CEO of the BCBB.
“Quality assurance in accordance with the principles of good laboratory practice (GLP) and good manufacturing practice (GMP) requires documentation to a large extent. By using the KMmaster large as well as small and medium-sized enterprises will benefit from this lean and web-based solution. Our Life Science Edition can be easily integrated into existing processes – even in small biotechnology companies. It supports an efficient management of SOPs and related processes. Additionally, the KMmaster can be upgraded with knowledge and innovation management features,“ says Dr. Tobias Müller-Prothmann, division manager innovation management at Pumacy.
BlisterCentrum Berlin-Brandenburg (www.blistercentrum.de/) developed with BOXITO an innovative packaging solution for pharmaceutical products. Pharmacies provide home care and chronically ill patients with patient-specific blisters packs. Forming, filling and sealing of a tubular film are carried out automatically based on given patient data. These data are electronically transferred from pharmacies to the BCBB. The manufacturing process under clean-room conditions is subject to the regulatory requirements according to GMP (Good Manufacturing Practice).
KMmaster®
KMmaster® (www.kmmaster.de) is a process-based knowledge management solution facilitating the administration of information and data.
Based on the KMmaster concept the solution can be customised to meet industry requirements as well as individual business needs and supports collaboration and communication in geographically dispersed companies. The systematic management of knowledge helps businesses improve their work practice and streamline business processes.
The KMmaster Life Science Edition is an industry solution designed for businesses in the biotechnology and pharmaceutical sectors. The solution provides basic features for the SOP management such as trainings management, 21 CFR Part 11 compliance and integrated audit trails.
Pumacy Technologies AG
The Pumacy Technologies AG company group (www.pumacy.de) is a leading knowledge management solution provider. The comprehensive portfolio of products and services is based on an interdisciplinary approach covering knowledge, process, and innovation management.
Pumacy Systems is an in-house software company of the Pumacy Group. The software KMmaster® (www.kmmaster.de) is a process-based knowledge management solution facilitating the administration of information and data.
Pumacy has customers who are known as leading manufacturers from the aerospace and automotive, the plant and machinery industries as well as the pharmaceutical industry. Pumacy has extensive references from significant international projects.