How Cegeka tackles GxP validation in pharmaceutical ERP projects

Dominique De Vos, Global Solution Manager Pharma & Life Sciences at Cegeka has an equation to make sense of digital transformation in the pharma landscape and beyond. NO + OT = CNO. In other words, “New Organization plus Old Technology equals Costly New Organization.” The equation is a reminder that legacy systems are often incompatible with modern pharmaceutical operations. This article has been published earlier here.

Pharmaceutical manufacturers face a convergence of intense pressures. In one corner, intensifying global regulations (like evolving GxP standards and serialization mandates) demand constant adaptation. In another, increasingly complex multi-stage supply chains require precise temperature control and traceability. Compounding these challenges is the urgent need to modernize costly, often siloed, legacy systems.

Successfully navigating this landscape requires more than generic IT solutions; it demands digital systems deeply integrated into core operations. Enterprise Resource Planning (ERP) platforms like Microsoft Dynamics 365 are crucial for improving efficiency and ensuring compliance. Yet implementing and validating these systems within the highly regulated life sciences sector is where standard approaches often falter. It requires specific expertise not just in the software, but in GxP compliance (Good Manufacturing/Distribution/Clinical/Laboratory Practices), Computerized System Validation (CSV), quality management integration, and the workflows of pharmaceutical production and batch release.

To understand how companies can bridge this gap, we spoke with Dominique De Vos, Global Solution Manager Pharma & Life Sciences at Cegeka.

Can you share an overview of how these ERP implementations have specifically addressed the unique challenges of pharmaceutical manufacturing and packaging? What are common challenges you’ve helped pharma clients overcome with such implementations?

Dominique: Pharmaceutical manufacturing and packaging present a unique set of challenges, particularly as companies expand globally and navigate increasingly complex regulatory landscapes. At Cegeka, we understand that scaling operations while maintaining compliance is crucial for our clients. Implementing Microsoft Dynamics 365 with our specialized Cegeka Pharma & Life Sciences for Dynamics 365 solution allows us to address these challenges through centralized data management, automated compliance controls, and enhanced supply chain visibility.

A significant 43% of executives in pharma are prioritizing global expansion and new product launches over the next two years, which requires managing diverse regulatory environments across multiple regions. Microsoft Dynamics 365, in combination with Cegeka Pharma & Life Sciences for Dynamics 365 solution, enables companies to harmonize operations, ensuring adherence with global standards like FDA and EMA, while supporting smooth cross-border supply chain coordination. With automated workflows, Microsoft Dynamics 365 ensures that companies can navigate evolving regulations with ease, reducing the risk of regulatory penalties, product recalls, or operational disruptions.

Research shows that 87% of pharmaceutical companies lack complete visibility into product conditions during the last mile of delivery, leading to inefficiencies and delays.

 

Supply chain visibility is another critical challenge, especially with time-sensitive products. Research shows that 87% of pharmaceutical companies lack complete visibility into product conditions during the last mile of delivery, leading to inefficiencies and delays. Microsoft Dynamics 365 enhances real-time tracking and supply chain insights, enabling companies to respond quickly to disruptions, maintain inventory accuracy, and ensure timely delivery of life-saving products, even across complex global networks.

Our Cegeka Pharma & Life Sciences solution combines deep industry expertise with a tailored ERP platform. It simplifies regulatory conformity, enhances supply chain visibility, and scales effortlessly to meet business growth. This comprehensive approach enables our clients to operate efficiently, respond to market demands, and maintain compliance across global operations.

In your recent LinkedIn posts, you’ve highlighted Cegeka’s work with companies. Could you share some examples of how digital transformation is improving efficiency or compliance in pharmaceutical production environments?

Dominique: Digital transformation is a game-changer for pharmaceutical production, allowing companies to enhance operational efficiency while staying ahead of evolving regulatory demands. We’ve seen firsthand how Microsoft Dynamics 365 delivers real-time insights, process automation, and robust frameworks that help our clients navigate these challenges.

A compelling example is our collaboration with Eurofins. Facing the limitations of an outdated ERP system, Eurofins needed a solution that could streamline global operations while maintaining regulatory adherence across multiple European sites. By implementing Microsoft Dynamics 365, we centralized Eurofins’ data management and improved their ability to respond swiftly to regulatory changes. This approach has simplified audits and has reduced the administrative burden on their teams, allowing them to focus on core business activities.

Another significant challenge is supply chain visibility and responsiveness, particularly for companies managing time-sensitive products. A recent project with a global radiopharmaceutical leader underscored the need for an integrated supply chain. With products that have a shelf life of just 48 hours, precise coordination across business units was essential to ensure timely delivery to patients worldwide. By implementing Microsoft Dynamics 365 with our Cegeka Pharma & Life Sciences solution, they gained real-time supply chain tracking and improved operational coordination, ensuring life-saving treatments reached patients on time across more than 60 countries.

In the case of our customer Nyxoah, digital transformation has enabled scalable, efficient processes across their expanding global footprint. By integrating their operations on Microsoft Dynamics 365, we established automated workflows and a single source of truth for regulatory reporting. This has allowed their teams to respond quickly to new market demands without compromising quality or compliance.

These examples highlight how our digital transformation initiatives empower pharmaceutical companies to adapt to industry demands, enhance efficiency, and maintain the highest compliance standards in an increasingly complex environment.

GxP compliance appears to be a key focus in your work. How is Cegeka helping pharmaceutical manufacturers ensure their digital systems meet these strict regulatory requirements while still enabling innovation?

Dominique: At Cegeka, we recognize that adhering to GxP guidelines—which cover a range of Good Practices, including manufacturing (GMP), clinical (GCP), laboratory (GLP), and distribution (GDP)—is essential for pharmaceutical manufacturers, particularly as they undergo digital transformation. While Microsoft Dynamics 365 provides a strong foundation for GxP compliance with built-in features like audit trails, data integrity controls, role-based access, and document management, it is essential to configure and validate the system to meet specific regulatory requirements.

This is where our partnership with Epista Life Science adds significant value. As specialists in Computerized System Validation (CSV) and GxP compliance, Epista ensures that every implementation meets stringent regulatory standards while supporting operational efficiency.

In close collaboration, we help pharmaceutical companies implement Microsoft Dynamics 365 in a way that ensures compliance while enabling innovation. Our combined approach includes validation support throughout the system lifecycle, from design through implementation and ongoing operation. By leveraging Epista’s deep expertise in CSV and GxP, we ensure that every aspect of the system is validated, and that all processes – such as batch production, traceability, and quality control – are fully compliant with regulatory standards.

Moreover, Microsoft Dynamics 365 offers the flexibility to drive innovation without compromising regulatory adherence. It allows manufacturers to scale efficiently, optimize supply chains, and improve production processes, all while maintaining the high regulatory standards required by the industry. The system’s adaptability ensures that manufacturers can implement new technologies and improve operational efficiencies without putting GxP compliance at risk.

In summary, Cegeka, in partnership with Epista Life Science, provides comprehensive support to pharmaceutical manufacturers to ensure GxP compliance with Microsoft Dynamics 365. Through CSV validation, automated controls, and our combined expertise, we enable clients to innovate confidently within a highly regulated environment, ensuring they remain compliant while achieving operational excellence.

How do you foresee AI and Copilot transforming pharmaceutical manufacturing operations in the next 2-3 years? And regarding cybersecurity, what is the current state of awareness within the sector?

Dominique: The potential of AI and Copilot technologies in pharmaceutical manufacturing is immense, and we’re only beginning to see their impact. In the next few years, these tools will help automate routine tasks, allowing professionals to focus on more meaningful work and reducing the risk of burnout—a common challenge in healthcare.

AI will significantly improve data integrity, security, and validity, which is crucial in a world that is increasingly focused on patient-centric care. Technologies like Copilot integrated into Microsoft Dynamics 365 will ensure better regulatory adherence by offering real-time assistance, reducing errors, and improving decision-making on the production floor. The Healthcare Information and Management Systems Society (HIMSS) www.himss.org is supporting this AI revolution by offering global guidance through their Responsible AI Policy Principles and providing professional development courses on AI, helping healthcare and pharmaceutical companies navigate the complexities of an implementation.

When it comes to cybersecurity, awareness in the pharmaceutical industry has significantly improved, especially as the sector faces increasing cyber threats. HIMSS is actively engaged in promoting cybersecurity best practices, including organizing forums with experts and releasing the annual Healthcare Cybersecurity Survey, which provides valuable insights into current trends, challenges, and strategies.

Software validation is often a significant hurdle for pharmaceutical companies. Could you explain how Cegeka approaches this process to reduce the burden on manufacturers while maintaining compliance?

Dominique: The answer to this question connects to question 3 about the end-to-end attention for regulatory requirements. In summary, Cegeka, in partnership with Epista Life Science, provides comprehensive support to pharmaceutical manufacturers to ensure GxP compliance with Microsoft Dynamics 365. Through CSV validation, automated controls, and our combined expertise, we enable clients to innovate confidently within a highly regulated environment, ensuring they remain compliant while achieving operational excellence.

Epista Life Science did not only verify our Cegeka Pharma & Life Sciences solution, but also the way we implement our solution at Pharma & Life Sciences manufacturing companies. Our implementation methodology has been validated in such a way that our project deliverables are fully aligned with validation deliverables according to GAMP5 recommendations, which allows our customer to pass (often unexpected or unannounced) audits by local and/or international authorities.

This way, we unburden our customers by guaranteeing that we keep our solution in a continuously compliant state, taking care of validation and testing throughout the entire lifespan of the solution, and in particular when platform releases are being launched by Microsoft twice per year.

43% of pharma executives prioritize expanding internationally and launching new products in the next 2 years.

Many pharmaceutical companies are expanding internationally. What are the key ERP considerations when supporting global operations across different regulatory environments?

Dominique: 43% of pharma executives prioritize expanding internationally and launching new products in the next 2 years, which clearly shows this is a top priority for many pharma manufacturing companies. Our global customers need to both scale their operations across diverse regulatory environments, and to manage R&D pipelines and to accelerate time-to-market, which requires seamless cross-border supply chain coordination.

The Microsoft Dynamics 365 Finance & Supply Chain Management solution provides out-of-the-box localizations for most countries worldwide, covering the country-specific accounting and legislation requirements. Moreover, this solution is designed to provide global capabilities, making it suitable for multinational organizations operating in diverse regions. Microsoft Dynamics 365 Finance & Supply Chain Management supports multiple languages, allowing users to interact with the system in their preferred language.

What impact is the drive toward sustainability having on pharmaceutical manufacturing technology, and how are you/Cegeka addressing these evolving requirements?

Dominique: Pharmaceutical companies have a considerable environmental impact in terms of waste disposal, CO2 emissions, plastic usage, and air pollution, water and energy consumption (including those related to transportation and refrigeration of drugs). In fact, pharmaceutical industry CO₂ emissions are 13% higher than those of the automotive sector, according to data from 2019. As sustainability becomes a global priority, the industry is under increasing pressure to reduce its environmental footprint while maintaining operational efficiency and regulatory conformity.

At Cegeka, we are helping our pharmaceutical clients embrace sustainability through digital transformation. By implementing Microsoft Dynamics 365, we are enabling manufacturers to optimize their operations, enhance resource management, and track energy usage more effectively. For example, AI-powered analytics within these systems can help identify inefficiencies in production processes and suggest more sustainable alternatives.

One key focus is supporting sustainable supply chain management. Through advanced tracking and reporting tools, we help pharmaceutical manufacturers monitor the carbon impact of their entire supply chain—from raw material sourcing to final product delivery. This allows companies to optimize transportation routes, reduce waste, and ensure compliance with global sustainability standards like ISO 14001 and emerging ESG regulations.

Additionally, our partnership with Epista Life Science enhances these efforts by ensuring that all digital systems comply with GxP regulations while supporting environmentally responsible practices. This balance between compliance and sustainability is critical as companies work toward greener operations without compromising data integrity or product safety.

Beyond technology, we recognize that true sustainability requires a cultural shift within organizations. We assist our clients in establishing standardized processes, reward programs, and staff training to encourage sustainable behaviors at every level. This holistic approach helps pharmaceutical companies not only reduce their environmental impact but also align with evolving global expectations around corporate responsibility.

For pharmaceutical manufacturers still using legacy systems, what would you identify as the most compelling reasons to undertake digital transformation now rather than later?

Dominique: I would like to summarize my point of view with the following ‘riddle’ :

NO + OT = CNO, which stands for NEW ORGANIZATION + OLD TECHNOLOGY = COSTLY NEW ORGANIZATION.

Delaying digital transformation in pharmaceutical manufacturing is becoming an increasingly risky and costly decision. Legacy systems, while familiar, often lack the scalability, compliance capabilities, and efficiency needed to navigate today’s fast-changing regulatory and operational landscape. There are several urgent reasons why transforming now is not just beneficial—but essential.

First, regulatory pressures are intensifying globally. With 53% of pharma leaders identifying increasing regulation as the #1 external risk (Gartner, 2024), outdated systems that rely on manual processes struggle to keep pace with evolving standards like FDA 21 CFR Part 11, EMA Annex 11, and new ESG reporting requirements. Modern ERP systems—such as Microsoft Dynamics 365—offer automated compliance controls, audit trails, and real-time reporting, reducing the risk of regulatory violations and costly regulatory penalties.

Second, operational agility is crucial in a competitive market. Pharmaceutical companies are under pressure to accelerate time-to-market while managing supply chain complexities and demand fluctuations. Legacy systems often operate in silos, limiting real-time visibility and creating bottlenecks in production planning and inventory management. Digital platforms provide end-to-end transparency, enabling manufacturers to respond more quickly to market changes, supply disruptions, or new product launches—a critical advantage as 43% of pharma executives prioritize global expansion over the next two years (Gartner, 2024).

Another compelling reason is data integrity and security. With the rise of cyber threats targeting the pharmaceutical sector, legacy systems—often lacking advanced security protocols—pose a significant vulnerability. Modern cloud-based ERP solutions provide robust cybersecurity measures, data encryption, and access controls to protect sensitive patient data and intellectual property while ensuring business continuity.

Finally, the cost of inaction is rising. Maintaining and customizing outdated systems is not only expensive but also inflexible when it comes to integrating emerging technologies like AI and machine learning. With tools like Microsoft Copilot, pharmaceutical manufacturers can automate manual tasks, enhance decision-making, and improve process efficiency—driving both cost savings and innovation.

At Cegeka, we work closely with pharmaceutical companies to make digital transformation a strategic enabler rather than just a technical upgrade. By adopting modern systems now, companies can future-proof their operations, ensure regulatory adherence, and gain the agility needed to thrive in an increasingly digital and regulated environment. Waiting only increases the risks and costs—transforming now is the smarter, safer choice.