IT quality management

We transform your IT quality management system into a lean version and increase the efficiency of your processes.

Effective and lean IT quality management

An effective IT quality management ensures stable and reliable services. This not only enables you to comply with relevant regulations like FDA title 21, CFR parts 11 and 820, ISO 13485 and ISO 62304, AMWHV or EU GMP Annex 11, but also increases the efficiency of your business processes and the value contribution of your IT.

Lean IT qualification processes

An efficient qualification strategy not only ensures the compliance with relevant regulations, but also allows you to increase the value contribution of your IT through lean processes and stable services while optimizing your costs.

Our special areas of expertise

Quality management system

We support you in setting up and optimizing your IT quality management system. In doing so, we advise you with regard to applicable regulations and support you in introducing suitable software solutions as well as in the establishment of defined guidelines in your organizational culture.

Project support

Our experienced quality managers support you while the introduction and roll-out of the software solutions. With the "right-the-first-time" approach we create efficient project processes and mediate between the business department, the IT and quality to ensure that applicable regulations are complied with from the very beginning.

Audit and asssessment

We prepare you optimally for your audits. Our compliance experts are there to support you from the initial assessment to the planning of measures and the implementation. Certainly, we will also provide you with targeted support after an audit to remedy any findings.

Consulting and qualification

We advise and support you in the qualification of your IT infrastructure. Thanks to our approaches, which are proved to work in daily business, we not only ensure compliance with relevant regulatory requirements, but also transform processes into lean ones and thus ensure efficient, cost-reduced IT operations.

Case study

In a recently conducted project we increased the efficiency, quality and consistency of a project quality management system in a globally active pharmaceutical group.

Your benefits

Years of experience

With over 20 years of experience in IT compliance we know what matters. Our experts advise and support you in strategy and governance issues as well as in the effective implementation in daily operations.

Stable and efficient IT operations

Thanks to the combination of IT and compliance we guarantee not only that all demands regarding regulations are fulfilled but also keep an eye on the practicability and efficiency of your IT-processes and -services.

Holistic approach

With our holistic approach and the "right-the-first-time" approach we ensure the compliance with valid regulations right from the start and in this way create efficiency in your projects.

Lean processes

With the guiding principle of "lean compliance" we create lean, modern and secure processes, which on the same time save costs and user ressources in a targeted and controlled manner.

Dedicated process knowledge

Thanks to our several years of experience in various industries we combine modern technology with our industry expertise to create efficient solutions that ideally support your business processes.

Targeted synergies

We guarantee you a central contact person, who will deal with all of your tasks. At the same time we have a team of experts for you, who develop the best solutions in close cooperation with you.

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I would like to organize a personal chat with you.
Head of the Compliance department and CEO of the Datalynx Group
Serge Meyer
Head of department compliance and CEO of the Datalynx Group

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