Agile Computer System Validation (CSV) and Software Life Cycle Management

In the age of digitalization, agile software development meets heterogeneous IT landscape. How do you ensure for instance the stability of the production and at the same time enable faster releases so as not to lose the market connection? Together with you, we develop your tailor-made IT processes, which meet all regulatory CSV requirements as well as the flexibility for the required speed of agile development.

Our solutions

your benefits

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Solution

  • Agile Computer System Validation and Verification (GAMP5/ IEC 626604/ 82304)

  • Development of strategy for Qualification and Validation of Digital Health Platforms

  • Development of IT strategies in order to lay the foundations for the transition to the digital age

  • Support to establish new forms of work and organization, such as DevOps, Kanban, Scrum, SaFE, LESS etc., in your IT department.  

Benefits

Profit from our extensive knowledge and experience in the field of Computer System Validation for the Medical Device as well as the Pharmaceutical industry. We will support you throughout the whole process: from requirement engineering all the way to acceptance testing and deployment of your system!

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Find out more about our solutions, sucess stories and relevant topics.

Meet our expert

Tanja Rohark

Chief Executive Officer & Founder

As Digital Chameleon’s founder, Tanja is both passionate about digital transformation and efficiency. Having successfully held diverse global corporate positions, implementing multi- cultural and multi-disciplinary projects, and programs, in the regulated Life Science and Health Sector, she is also highly-skilled at managing near-shore and/or off-shore teams across multiple locations. Her deep knowledge and understanding covers key areas such as Digital Health Technology Compliance & Quality Management, Audit Management, Business Analysis and Requirements Engineering Specialist, Coaching Change and Communication Management, as well as a global IT and Business Transformation Programs. Tanja is customer-focused, always motivated to exceed expectations, allowed her to serve clients such as Altatec, Basel/CH, Wimsheim/DE, Sutter Medizintechnik, Fresenius Kabi, SwissBioSim, Fresenius Kabi Digital Lab, Novartis Pharma, Fresenius Kabi Worldwide, Deutsche Telekom, Evonik (Degussa) AG, Düsseldorf, and RWE AG.

+41 (061) 311 54 01

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