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Compliance services for regulated industries

Compliance Services

We specialize in governance, risk management, compliance (GRC) and validation services for regulated companies in the pharmaceutical and healthcare industries.

Companies operating in the pharmaceutical and healthcare sector are subject to specific regulations of the health authorities. It is imperative that they ensure that their IT infrastructure, their digitalized laboratory equipment and the applications used meet all regulatory requirements. It goes without saying that, under these circumstances, it is not always easy to digitalize business processes in such a way that they meet compliance requirements.

Are you struggling with this very challenge? We have the expertise to guide you through the digital transformation and develop IT compliance solutions and processes that take the regulations into account.

We have developed our own process with which we approach this complex task professionally and, based on our many years of experience, create IT compliance solutions for you that ensure efficient processes and reduce risks.

We also offer you further services and advice on all aspects of IT compliance, such as quality assurance and qualification, data validation, validation and risk management or project support.

If you have specific questions about IT compliance, please contact us! We will provide you with expert advice.

Governance

For us, governance in IT means ensuring that organizational structures and processes are defined in such a way that the IT infrastructure optimally supports
both corporate strategy and objectives.

Companies operating in the pharma & healthcare sector are subject to specific official regulations. The company's information risk can only be realistically calculated if they know the exact access processes, authorizations and storage locations of their data.

We specialize in information classification, security and governance and have the necessary expertise to professionally position companies for the secure handling of sensitive data.

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Risk Management

Sensitive company data harbors risks. We deal with your information risks at an early stage, evaluate them and develop appropriate strategies to minimize the overall risk.

There is always a risk that the confidentiality, integrity and availability of sensitive company data and information may be maliciously or accidentally compromised. In order to correctly assess the information risk, regular data checks are necessary.

We take over the risk management and evaluation of your data for you so that you can quantify your specific risk at company level and make well-founded decisions on this basis.

Compliance

Our focus is on meeting the compliance requirements that affect a company's IT systems. These requirements include information security and therefore also the availability, storage and protection of company data.

This service includes the development and implementation of policies, procedures and internal controls to ensure that they meet the relevant compliance requirements.

We take on all the necessary preparatory work for you and ensure that your IT systems are developed, qualified, validated and operated in accordance with the official guidelines, procedures and processes. We can support you either integrated into your team or as external consultants.

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Validation as a Service

We focus on the quality assurance of the applications and devices used. We check their suitability based on the requirements profile and intended use in order to ensure high data quality while adhering to compliance requirements.

Our experts ensure the compliance of the devices and applications you use so that you can guarantee the consistently high quality of your data without any administrative effort on your part - and this with flexibly scalable capacity and optimized costs, which we communicate to you transparently.

We manage a pool of qualified validation leads and analysts for you and ensure that you have access to exactly the resources you need at all times. We also check compliance with validation requirements across all areas. We provide you with a service manager who proactively deploys your resources according to your current needs and ensures the compliance of your devices and applications both in the project business and in day-to-day operations. 

We take care of the selection and training of all validation experts. Nevertheless, you retain full control and can reject proposed resources at any time.

Monthly reports provide you with an overview of the current status and a forecast for the next three months. With jointly agreed KPIs, such as the average review time or the fluctuation rate of resources, we achieve our goal of not only meeting your quality requirements but exceeding them. This allows your internal quality management to concentrate fully on its core activities.

Services briefly explained

Efficient IT quality management and an optimal qualification strategy together form the basis for stable and reliable IT services.

We ensure that you comply with all relevant GxP regulations - such as FDA Title 21, CFR Part 11 and 820, ISO 13485 and ISO 62304, AMWHV or EU GMP Annex 11.

We also support you in setting up and optimizing your IT quality management system and advise you on compliance with applicable regulations and the introduction of a suitable software solution. We also offer support in establishing a set of rules for your organizational culture.

Thanks to our combined expertise in IT and IT compliance, we always keep an eye on the practicability and efficiency of your IT processes and Services. In this way, we not only ensure that the requirements of the regulations are met, but also increase the efficiency and stability of your business processes and the value contribution of your IT.

With our support, you can look forward to external audits with confidence.

Our service managers proactively organize your quality operations and increase the efficiency of your quality management. We offer you support in CAPA (Corrective and Preventive Action) management, complaint handling and document change control, or we can take over your entire quality operations. In this way, we ensure greater product and customer satisfaction.

We deploy our quality management and compliance consultants in a targeted manner and according to your current needs.

On the basis of key performance indicators (KPIs) created together with you, we ensure that your quality operations meet both internal and external requirements.

Our experienced quality managers accompany you along the entire quality lifecycle. We implement solutions that we have tested and proven in practice into your day-to-day operations, streamline processes, free you from legacy issues and ensure operational efficiency under the guiding principle of «lean compliance».

Our experienced quality managers support you in the implementation and roll-out of the software solutions that are best for you. With our holistic «right-the-first-time» approach, we ensure lean project processes and mediate between the IT and quality departments so that the applicable regulations are followed consistently right from the start.

With us, you have a fixed contact person for your project who will communicate with you regularly about the progress of the project and who you can contact at any time if you have any questions.

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

Contact

Would you like to know more?
I will gladly make time for you.

Serge Meyer

Head of Compliance / Group CEO

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Supplementary services of the Datalynx Group

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