Quality & GxP Compliance

Implementation of GxP-compliant IT systems

Future-proof right from the start

Safe. Efficient. Reliable.

Our IT projects in the life sciences industry are consistently supported by an experienced validation manager to ensure full GxP compliance. Whether it’s an S/4HANA transformation, the implementation of a LIMS, or the development of GxP-compliant software solutions – we’re right by your side. Validation is not treated as an extra burden, but as an integral part of our project approach – fully aligned with all stakeholders and seamlessly embedded in the overall planning. With us, you get everything from a single source.

Our Services

  • Validation Across the Entire System Lifecycle

    We provide end-to-end validation solutions across the full lifecycle of computerised systems (CSLC). Starting with a GxP maturity assessment, we develop a tailored CSV strategy aligned with your organisation and regulatory requirements. We support you through all validation phases – from documentation and IQ/OQ/PQ testing to periodic reviews and continuous change management. Even during system retirement, we ensure you remain fully compliant. Contact us

  • Qualification of Cloud Infrastructures

    Cloud infrastructures offer significant potential, especially in the life sciences industry. A GxP-compliant qualification is essential to ensure data integrity, security, and regulatory compliance. We qualify your cloud solutions according to applicable standards such as the EU GMP Guidelines (Annex 11) and FDA 21 CFR Part 11. Our services include risk assessment, infrastructure documentation, and validation of the technologies used. This allows you to leverage the benefits of cloud technologies without compromising on compliance. Contact us

  • Development of GxP-Compliant Software

    We develop your software in full compliance with GxP requirements, taking into account all regulations relevant to your product — including electronic signatures, audit trails, and other regulatory guidelines. From initial planning to market launch, we integrate GxP requirements, conduct risk assessments, and prepare all necessary validation documentation. Our approach combines compliance, innovation, and efficiency. The result is audit-ready, future-proof software that ensures quality and strengthens your competitive edge. Contact us

Strong Partnerships for your Success

Our Success Stories

Pharma

GDP-Compliant S/4HANA Transformation

As a pharmaceutical wholesaler, our client is subject to the requirements of Good Distribution Practice (GDP). At the same time, the company includes other areas that are not GxP-relevant. Within the S/4HANA transformation, adesso Life Sciences is responsible for validating the GDP-relevant processes, while the overall project is managed by the experts from adesso Business Consulting. Validation activities are fully integrated into the project approach, enabling a joint testing phase for both GDP and non-GxP processes and ensuring a synchronized go-live. To keep the validation effort efficient, we apply a strictly risk-based validation approach.

Pharma

GMP-Compliant Implementation of Microsoft D365 FSCM

Together with adesso’s Microsoft experts, Microsoft D365 FSCM is being implemented as a cloud-based ERP solution at a mid-sized pharmaceutical company in Germany. The goal is to replace paper-based and manual processes and to establish an end-to-end process mindset across the organization. This transformation is actively supported by adesso’s Organizational Change Management team. A key focus of the ERP system validation lies in the qualification of the cloud infrastructure to ensure GMP compliance at all levels. The interdisciplinary adesso project team works hand in hand to successfully manage the ERP implementation and transformation alongside ongoing business operations.

Pharma

Development of a GxP-Compliant Software Product

In this project, a GxP-compliant software solution was developed for use in biopharmaceutical quality and in-process control. The foundation was an existing non-GxP software that was further developed in a fast and cost-effective manner, based on modern compliance standards in accordance with FDA 21 CFR Part 11 and EU GMP Annex 11. Despite a significant scope creep with well over 100 user stories, the project was completed on time. The solution meets all regulatory requirements, including audit trail and electronic signatures.

Customer feedback was very positive, with a rating of 4.8 out of 5. The collaboration was described as efficient, collaborative, and highly pleasant.

Selected References

Life Sciences Magazine

What to expect

Dive into our innovative solutions and discover how we can help transform your Life Sciences business with cutting-edge IT strategies and expert insights. Look forward to exploring the following topics:

  • Commercial Excellence
  • Medical Devices
  • Successful ERP Transformation
  • Laboratory Digitalization
  • Cloud Adoption in GXP Environment
  • Digital Production
  • Generative AI


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Do you have any questions?

No website or brochure can ever trump a face-to-face discussion about the goals and issues that are relevant to you. We look forward to meeting you in person. Get in touch with us!