Life ScienceSecurity, traceability and efficiency! In Life Science we are experts in developing, implementing and qualifying computer systems in business subject to regulatory requirements. We combine in-house developed solutions with market leading products, supplied by competent partners. Our development and project work are performed according to a proven quality assurance model, which is based on the recommendations in GAMP. One off our prime areas is electronic record management. We are often involved in early stages of projects, where we analyze the needs and can propose solutions that integrate both new and existing systems in the most cost-effective way. Our mission is that our solutions shall support compliance to regulatory requirements, and at the same time create more efficient business processes. Application areasElectronic batch records Achieving compliance in ERP systems is not so easy because of validation issues. Our strategy is to support the ERP system with a sub-system that controls all the GMP information. This makes validation easier, secures traceability and facilitates a paperless production. The solution is developed for Microsoft Axapta, but may in principle be integrated with any brand of ERP system. ArtWork Management With ArtWork Management, the complete process from manuscripts to printed material is functionally supported and quality assured, it may be labels, leaflets or cardboard boxes. The solution provides full versions and drafts management with annotations, and includes electronic proof-reading, both graphical and text wise, to support spellchecking or language independence. Fulfills all requirements for trace-ability and electronic records and signatures. Inspection systems for control of printed packaging material Extends ArtWork Management with automated proof-reading of delivered printed material. Proof-reading is performed on image level, which provides for exact content and quality control, independent of language. Reduces the time needed from hours to minutes, and virtually eliminates the undiscovered errors. Laboratory Automation Solutions for laboratory information management by traditional LIMS systems and systems for Electronic Laboratory Notebooks. The systems supports a variety of quality and regulatory standards, for example for electronic records and signatures.
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