Microsoft ERP in Life Sciences

Efficient ERP implementation in a regulated environment

Your ERP partner for Life Sciences

The implementation of an ERP system in Life Sciences requires special attention to regulatory requirements, quality assurance and traceability. adesso has extensive experience in these areas as well as in system implementation. An experienced team will advise you on the necessary steps and changes in your organisation. The combination of life sciences expertise and Microsoft ERP know-how creates added value that goes far beyond the sum of the individual competencies:

  • Industry knowledge
  • Experience with regulations and CSV
  • System expertise with Microsoft Dynamics 365
  • A proven process model

The close integration and coordination of core competencies creates more than just the sum of the individual building blocks and competencies. This results in countless advantages and genuine added value for ERP projects in regulated environments.

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System implementation

adesso has a team of specialists with over 20 years of experience in the introduction and operation of ERP systems, in particular Microsoft Dynamics 365.

What makes this team special is that around half of its members understand the challenges from the customer's perspective, while the other half contribute their consulting expertise. This combination makes it possible to successfully implement even complex projects. This expertise is complemented by Microsoft's ‘Success by Design’ methodology and adesso's own process model, which covers regulatory requirements. This enables the validated, secure and auditable implementation and operation of Dynamics 365 ERP.

Computer System Validation (CSV)

At adesso, computer system validation is not an add-on, but an integral part of every software implementation project.

An experienced team supports companies in the life sciences industry with regulatory-compliant implementation.

The approach:

Planning from the end user's perspective

Development and operation of the best possible and compliant software solution

Ensuring that validation, compliance and usability go hand in hand

The role of compliance and regulation in ERP projects

In the highly regulated life sciences industry, it is not only functionality and efficiency that determine the success of an ERP project, but above all consistent compliance with regulatory requirements. Whether EU GMP Annex 11 or FDA 21 CFR Part 11: compliance is not an ‘add-on’, but an integral part of system architecture and process design.

An ERP system that does not take these regulatory requirements into account from the outset carries considerable risks: from project delays and additional validation efforts to massive compliance violations. This means that regulatory requirements must be strategically anchored in the project – not just dealt with operationally.

Our experience shows that when compliance and IT go hand in hand, the result is not only a secure but also a sustainable ERP system that allows for innovation without jeopardising the regulatory basis. Don't compromise. Turn compliance into a competitive advantage!

Your advantages with a regulatory-based ERP approach

  • Seamless integration of GxP-relevant processes
  • Validation-secure system architecture
  • Future-proofing for audits and inspections
  • Minimisation of project risks through compliance by design

  • The introduction of an ERP system in the life sciences industry is a critical step that must meet regulatory requirements. Computer system validation (CSV) ensures that all GxP-relevant functions of the ERP system work reliably and in compliance with regulations. Our CSV team is part of the project from the outset and develops a tailor-made CSV strategy that is tailored to your organisation and requirements. A validation manager ensures that the IT project and quality management are successfully linked. Early QA involvement, standardised templates, automated testing tools and training ensure compliance as well as budget and time. The CSV team is flexibly scalable and an integral part of the project team.

  • The validation plan (VP) documents the tailor-made CSV strategy and defines goals, scope and responsibilities. Initial training creates a common understanding within the project team. A holistic risk analysis identifies and evaluates potential GxP and business risks that could arise from the ERP system. Risk mitigation measures are developed and implemented to avoid serious impacts on patient health. Comprehensive testing is often not feasible, so we focus on two key points. An important aspect of GxP projects is the updating or creation of SOPs and work instructions, as well as user training. Users must operate the ERP system correctly and comply with regulations. This requires comprehensive training and regular refresher courses, especially when system changes are made. Training certificates are fulfilled via a role-based training concept that is linked to the authorisation concept. Careful validation steps ensure that the ERP system contributes to efficiency and security in the life sciences industry.

    • Early, informal testing to identify any errors as early as possible and correct them directly during the development process.
    • Risk-based testing: Risk analysis is used to identify critical processes, functions and variants and classify them according to their criticality. This classification forms the basis for documented and undocumented testing. Here, we work with you to develop a testing strategy that is tailored to your company, project budget and timeline, and is supported by IT and QA.

    An important aspect of GxP projects is the updating or creation of SOPs and work instructions, as well as user training. Users must operate the ERP system correctly and comply with regulations. This requires comprehensive training and regular refresher courses, especially when system changes are made. Training certificates are fulfilled via a role-based training concept that is linked to the authorisation concept. Careful validation steps ensure that the ERP system contributes to efficiency and security in the life sciences industry.

  • When selecting and evaluating suppliers in a regulated environment – especially in the context of an ERP project or GxP-relevant systems – it is not only economic or technical factors that matter, but also the supplier's ability to meet regulatory requirements on a permanent basis.

  • These points apply to all suppliers, regardless of whether they supply GxP-relevant systems or not:

    • Financial stability: credit rating, annual reports, solvency
    • Technical competence & product quality: references, market position, degree of innovation
    • Experience in the life sciences industry: understanding of industry-specific requirements?
    • Support & services. Response times, availability, SLAs
    • Contractual security & compliance: data protection, confidentiality agreements, service contracts

  • These criteria are particularly important if the supplier provides GxP-relevant IT systems or software (e.g. ERP, MES, LIMS):

    Software development & quality assurance
    • Does the supplier follow a documented software development life cycle (SDLC)?
    • Are there defined processes for:
      • Requirements management
      • Software testing (unit, integration, regression)
      • Error management & CAPA
      • Documentation & change management
    • Does the development process comply with GAMP 5 (category 3 or 4/5)?
    Documentation & validatability
    • Does the provider supply validatable documentation (URS, FS, DS, test plans)?
    • Are there audit trails, user roles and security concepts in the product?
    • Can the provider actively support validation (with templates or test cases)?
    IT security and data integrity
    • Are security mechanisms (backup, access controls, authentication) fulfilled?
    • Does the system support data integrity according to ALCOA+?
    • Are cloud/SaaS models compliant with EU GDPR and Annex 11?
    Audits & certifications
    • Are ISO certifications available (ISO 9001, ISO/IEC 27001)?
    • Is there experience with regulatory audits (FDA, EMA)?
    • Is the supplier willing to conduct GxP audits or on-site inspections?

Why is Microsoft D365 FSCM particularly well suited for life sciences companies?

Microsoft Dynamics 365 Finance and Supply Chain Management (FSCM) is a comprehensive ERP solution that is particularly well suited for the life sciences industry thanks to its end-to-end implementation of process manufacturing, including digital production protocols (Electronic Batch Record, EBR) and comprehensive handling and tracking of batch-managed products.

Compliance with legal regulations is ensured by advanced quality management. Corrective and preventive actions (CAPA) support continuous improvement in product quality and minimise manufacturing risk. In addition, the software's architecture complies with key standards such as 21 CFR Part 11, EU GMP Annex 11, GAMP 5 and GoBD.

Which functions in the standard software are particularly valuable for companies in the life sciences sector?

  • Process manufacturing (batch production) with formulas, co-products and by-products
  • Comprehensive support for batch handling
  • Digital production records (EBR)
  • Production dispensing
  • Management of corrective and preventive actions (CAPA)
  • Creation of certificates of analysis (CoA), including customised ones
  • Native support for electronic signatures
  • Creation of product compliance reports for authorities, such as EPCRA, CERCLA, TSCA, TRI, OSHA, EHS
  • Management of hazardous substances and goods in accordance with the requirements of ADR, 49 CFR, IMDG, IATA
  • Handling of dual-use goods in accordance with GKG and GKV
  • Monitoring of compliance with export control laws
  • Engineering change management
  • Connection of sensors, e.g. in production with Sensor Data Intelligence

Extension of the system within the Microsoft platform

Microsoft Dynamics 365 Finance and Supply Chain Management can be expanded in many ways as part of the Microsoft Power Platform cloud ecosystem. Processes can be automated, data can be intelligently evaluated, and apps can be developed without programming knowledge.

With Microsoft Power BI, you can analyse your data and visualise the results. Pre-integrated reports in FSCM are also available for this purpose.

With Microsoft Power Automate, you can create workflows to automate manual tasks such as approval processes, notifications or the integration of data from other systems.

Microsoft Power Apps enables you to develop applications that work with the data in FSCM without any programming knowledge.

By integrating Microsoft Azure Machine Learning or AI Builder, you can incorporate forecasting functions into FSCM.

Do you have any questions?

Let's talk about how we can implement your ERP project. I look forward to making an appointment with you.