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 effect of your business processes and the value contribution of your IT.

Lean IT qualification processes

With an efficient qualification strategy, you ensure compliance with all relevant regulations and increase the value contribution of your IT with efficient 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. We advise you on compliance with applicable regulations and the introduction of a suitable software solution. In addition, we offer support in setting up a defined set of rules for your organizational culture.

Project support

Our quality managers support you with their years of experience during the implementation and roll-out of the software solutions. With the «right-the-first-time» approach, we create lean project processes and mediate between business departments, IT and quality so that the applicable regulations are followed from the very beginning.

Audit and assessment

We prepare you optimally for your audits. Our compliance experts are at your side with advice and support from the initial assessment to the planning of measures and concrete implementation. Of course, we also accompany you after the audit so that you can solve newly defined goals, topics and tasks accordingly.

Consulting and qualification

We advise and accompany you in the qualification of your IT infrastructure. Thanks to our tried and proven approach, we not only guarantee compliance with the relevant regulatory requirements, but also streamline your processes and organize your IT operations in an efficient and cost-conscious manner.

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 our more than 20 years of experience in IT compliance, we know what is important and relevant. Our experts advise and guide you in your questions about strategy and control as well as the effective organization and implementation of your daily operations.

Stable and efficient IT operations

Thanks to the combination of IT and compliance, we not only guarantee that all regulatory requirements are met, but also always keep an eye on the practicability and efficiency of your IT processes and services.

Holistic approach

With our «right-the-first-time» approach, we ensure the implementation of the applicable regulations from the very beginning and thus ensure an efficient realization of your project.

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

Based on our many years of experience in various industries, we combine state-of-the-art technology with the knowledge gained from our projects to design efficient solutions that optimally support your business processes.

Targeted synergies

We guarantee you a permanent contact person who will deal with all your concerns. At the same time, we have a team of experts ready to work closely with you to develop the best solutions for your individual needs.

Personally there for you

I would be happy to talk to you.
Head of the Compliance department and CEO of the Datalynx Group

Serge Meyer
Head of Compliance
Group CEO (Chief Executive Officer)

Arrange a personal conversation with us

For requests via e-mail please use our contact form.