Effective IT quality management ensures stable and reliable services. This not only enables you to comply with relevant regulations (e.g. FDA Title 21 CFR Part 11 and Part 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.
- Stable, reliable IT Services
- Compliance with GxP Regulations
- Audit Safety
- Efficient, cost-reduced IT Operation
An efficient qualification strategy provides not only ensures 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 areas of expertise
QM Systems
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 the introduction of a suitable software solution as well as in the establishment of defined guidelines in your organisational culture.
Project Support
Our experienced quality managers support you in the introduction and rollout of software solutions. With the "right-the-first-time" approach, we create efficient project processes and mediate between the business department, IT and Quality to ensure that applicable regulations are complied with from the outset.
Audit & Assessment
We prepare you optimally for audits. Our compliance experts are there to support you in word and deed from the initial assessment to the planning of measures and their concrete implementation. Naturally, we will also provide you with targeted support after an audit to remedy any findings.
Consulting & Qualification
We advise and support you in the qualification of your IT infrastructure. Thanks to our tried-and-tested approach, we not only ensure compliance with relevant regulatory requirements, but also streamline processes and thus ensure efficient, cost-reduced IT operations.
case study
In a recent project we increased the efficiency, quality and consistency of Project Quality Management (PQM) in a global pharmaceutical group.
Your advantages
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
By combining IT and compliance, we not only ensure that regulatory requirements are met, but we also ensure that your IT processes and
Holistic Approach
With our holistic approach and the "right-the-first-time" approach, we ensure compliance with applicable regulations right from the start - thus creating efficiency in projects.
Lean Processes
With the guiding principle of "Lean Compliance", we create lean, modern and secure processes that simultaneously save costs and use resources in a targeted and controlled manner.
Dedicated Process Knowledge
Thanks to our many years of experience in various industries, we combine state-of-the-art technology with industry expertise to create efficient solutions that ideally support your business processes.
Targeted Synergies
We provide you with a contact person who will take care of all your concerns - and have a team of experts in the background who work closely together to create the ideal solution for you.
Personal for you
I am at your disposal for a personal conversation.
Serge Meyer
Head of Compliance & Group CEO