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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