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Case Study


New activities

  • Paperless validation
  • Data integrity, with focus on the data lifecycle
  • GMP software development and delivery support
  • Equipment qualification and support to FAT and SAT
  • Support to QA in managing departmental engineering changes
  • Analysis and definition of a risk based approach for Audit Trail Review
  • PMO support for project management or as Business Analyst
  • Qualification of environments, including sampling and microbiological analysis

ERP validations

  • SAP: 12 companies and more than 25 sites
  • Microsoft AX: 5 companies, total 7 sites
  • ORACLE Applications: 2 companies
  • AS400: 6 companies
  • METODO: 2 companies
  • BLENDING: 7 companies
  • PARCEL: 4 companies
  • JAIMS: 1 company

“Pure” software validations: 12 companies

  • software dispensing and tracking
  • LIMS
  • maintenance software
  • MES

Several experiences on CDMD/DCS Client-Server such as Empower 3, Chromeleon, OpenLab,...


SCADA/DCS validations

  • Siemens, iFIX: preparation lines and HVAC, water system, undervacuum homogeneizers, palletising.
  • Eurotherm (e-suite): new sterile antibiotics department, lyophilizers, undervacuum homogeneizers, warehouse monitoring systems.
  • Data collection platform validation (OSISoft-PI)


Data Integrity

Assessment and Gap Analysis of Data Integrity and Production/Laboratory validation status: more than 16 companies.


IT infrastructures

  • Factory/Site IT infrastructures validation
  • IT services Audit
  • Supplier Audit
  • Disaster Recovery validation (VMware) of some systems
  • Configuration and Help Desk Management Process Validation


Cloud - new challenges:

  • how to implement GMP applications on mobile devices (smartphone, tablet) 
  • how to store critical info in cloud 
  • how to manage the outsourcing of IT services (IaaS, PaaS, SaaS)

Other experiences:

  • Integrated in line processes for production standardization
  • Electronic record batch
  • Medical Devices Software Validation (ISO 62304:2006)
  • Validation according to ISO 13485 (Medical Devices)
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