your guide to quality
The digital transformation is getting faster and faster, many companies already initiated digital projects.
Our industry experts, experienced consultants from the areas of quality, compliance, SAP QM and digitization support you in the definition and implementation of your individual transformation.
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With more than 25 years of experience in the Life Science industry, we develop scalable solutions helping you to be one step ahead of your competition.
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Tailored to your individual requirements
Quality Managment
If you can answer yes to any of these questions, you find the right company to support you.
You would like to :
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Transform your laboratories into the "digital world" (employees - laboratory equipment – SAP - LIMS)
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Integrate new processes in the area of QC / QA into your existing IT landscapes. (not every problem requires a new system!)
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Get the best out of the SAP module Quality Management (SAP QM)
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Optimize your SAP QM system along the value chain
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Take the opportunity to control your processes in the laboratory with innovative master data concepts
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Establish transparency across your entire QC processes with meaningful KPIs/reports
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Ensure data integrity along your QC / QA processes
Are you interested in more information? Please contact Jürgen Brunny
Computer System Validation and Compliance
Actually, projects with GxP relevance seem to reach the limits of availability of internal resources and internal expert knowledge. The root causes for that are the special time at the moment where flexibility, pragmatism und the concentration of core competency as well as the paradigm shift of IT, digitisation und the use of artificial intelligence (AI) are real challenges for every company.
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​Our experts can support you well-directed for those topics.
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​Do you plan the revalidation, an upgrade or a new implementation of a GxP relevant computer system? Do you have a lack of resources to maintain the valid state of your GxP systems? Do you need support for the change management or the application maintenance of your GxP systems?
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​Our specialists are working longtime as Validation Manager, QA and project leads - especially also in the SAP environment. Topics as GxP, Part 11, Audit Trail Review, Data Integrity, Change Management, Validation Framework, Data Security, ITIL, SOPs, GxP Training, GxP in the Cloud, …, are their daily business. Those specialists are gladly right by your side to manage the related challenges.
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​Feel free to contact us. We will find the ideal solution for your special requirements.
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Please direct your inquiry to our managing director for that area – Michael Steffner will gladly help you.
Our customers are international companies from the pharmaceutical and chemical industry and medical technology sectors.
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They have one goal in common, to optimize the use of their SAP system and processes.
Our customers appreciate us for the holistic consulting approach, end-to-end, putting the employee in the focus of our projects.
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We support you to keep the life cycle documentation up to date with the official requirements (FDA, GAMP, GMP ...).
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Customized to your needs, we take over the entire project management or support you with our expertise in specific project steps.
Customer
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