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Case Study

 

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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