A customer develops software intended for use in the pharmaceutical industry. EXCO supports the validation of software and computer systems.
Tasks
An EXCO team first reviewed the customer's validation process and identified its strengths and weaknesses. Based on the analysis results, EXCO developed and implemented a validation strategy. All necessary validation activities were identified and carried out by EXCO. Through ongoing training-on-the-job, the client was enabled to independently perform CSV-related activities in the future.
Implementation details
- Identification of GxP-relevant IT systems and processes
- Gap analysis of the existing validation process
- Development of an optimized validation process and validation strategy
- Coordination of validation activities
- Agile validation
- AI validation
- Coaching and workshops
“Working in the medical and pharmaceutical environment is rewarding because your work helps improve people's lives.”
Client benefits
- Enhanced expertise: Knowledge transfer enabled the customer to develop software in a validated and legally
- Audit readiness and compliance: Through its collaboration with EXCO, the customer now has a sustainable process that provides confidence and regulatory compliance in future audits.
Client
Medium-sized company in the pharmaceutical sector
