Microsoft in Life Sciences

Your Microsoft partner for life sciences

IT in a regulated environment

A particular challenge

The introduction of an IT system in the regulated environment of life sciences poses a particular challenge. Strict rules and regulations are designed to ensure the safety and efficacy of products – and thus protect people.

A key element in the implementation of an IT system for life sciences companies is computer system validation (CSV). This ensures that systems comply with legal requirements when they go live, function reliably and that changes are introduced in a controlled manner.

During the operational phase, the validated status must be maintained – therefore, every change is subject to controlled change management. In order to implement an IT system for a life sciences company, significantly more than just implementation experience is required. This ‘extra’ is a basic prerequisite for successful implementation that complies with regulations. adesso offers this ‘extra’.

Key areas of expertise:
Pharma-biotech
Medical technology and material sciences
Pharmacy wholesaler
Pharma-biotech

The following special features apply to ERP implementation in the pharmaceutical and biotech sector.

    • Compliance with 21 CFR Part 11 (FDA) and EU GMP guidelines
    • Audit trail for all quality-related data
    • Electronic signatures and authorisation management
    • Integrated CAPA, deviation and change management processes
    • Lot and serial number management for batch traceability
    • Connection to LIMS, LIS, ELN
    • Document control for SOPs, test reports, etc.
    • IQ, OQ, PQ (installation, operational and performance qualification)
    • Creation and maintenance of validation documentation
    • Risk analyses (FMEA, HACCP) and risk-based approach

Medical technology and material sciences

Medical technology and material sciences

In medical technology and material sciences, the following requirements in particular must be observed.

    • Compliance with MDR (Medical Device Regulation) and national requirements
    • Requirements in accordance with ISO 13485 (quality management system for medical devices)
    • Audit trails, document control and electronic change management
    • Integrated processes in accordance with ISO 14971 for risk assessment and control
    • Tracking of CAPA (Corrective and Preventive Actions)
    • Unique Device Identification (UDI) for medical devices
    • Serial and batch management throughout the entire life cycle
    • Connection to LIMS, MES, PLM or test bench software
    • Synchronisation with e-document, e-signature and e-archiving solutions

Pharmacy wholesaler

The introduction of an ERP system in pharmaceutical wholesale requires special consideration: strict regulations, interactions between different products with limited shelf lives, and complex logistics processes are decisive factors.

    • Good Distribution Practice (GDP): Compliance with GDP guidelines for the storage and transport of medicinal products
    • Falsified Medicines Directive (FMD): Serialisation, upload/download of security features and traceability
    • Shelf life and temperature management: Batch and serial number management with expiry dates and audit trail for temperature-controlled products
    • Recall management: Rapid identification and recall of affected batches
    • Purchasing and supplier management: Order proposal logic based on consumption forecasts and supplier qualification
    • Sales and order processing: Customer master data maintenance, discount and condition management, automated invoicing
    • Warehouse and transport logistics: Multi-temperature warehousing, slotting optimisation, route planning, freight cost research
    • Finance and controlling: Accounts receivable/accounts payable accounting, cash management, margin analyses and reporting
    • Quality management: Document control (SOPs), CAPA, audit trails and workflow for approvals
    • Audit trails and electronic signatures: 21 CFR Part 11 or EU equivalents for all quality-related actions
    • Batch tracking (track and trace): Complete documentation from goods receipt to goods issue
    • Data integrity: Checks for completeness, consistency and traceability
    • Data protection and IT security: GDPR-compliant customer data processing, role-based access control
    • Temperature-controlled warehousing: Temperature zones, alarm logic, calibration and documentation
    • FIFO/FEFO strategies: Automatic transfer according to expiry date
    • Cross-docking and consolidation: Optimised handling processes to reduce throughput times
    • Returns handling: Reservation, quality inspection and restocking
    • Connection to serialisation systems: Data exchange for FMD/SecuReData
    • Connection to e-prescription management
    • TMS/WMS/LVS coupling: real-time communication with transport and warehouse management systems
    • E-invoicing and EDI: standards such as EDIFACT, XML or PEPPOL for wholesale customers and authorities
    • API and EDI gateways: scalable integration layer for e-commerce, field service apps and supplier portals

Microsoft ERP in life sciences

Efficient ERP implementation in a regulated environment

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.

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