This comprehensive case study explores Kymanox’s approach to enterprise SAP system consolidation and Computer System Validation (CSV) through risk-based harmonization and GAMP 5 compliance frameworks. Our team of Subject Matter Experts (SMEs) collaborated closely with Fortune 200 life sciences stakeholders to implement measurable improvements across multi-country system integration. This support included legacy functionality migration, GMP compliance, and Annex 11 validation for complex global SAP implementation projects.
CHALLENGE
SOLUTION
RESULTS
- Fortune 200 life sciences organization required consolidation of six (6) separate SAP instances into single GAMP 5-compliant, multi-country, multi-site validated SAP system.
- System alignment with SAP global vision essential incorporating harmonization across international sites and systems with strict adherence to GMP and EU Annex 11 standards.
- Aggressive project timeline and budget constraints demanded efficient execution without disruption to ongoing business operations and manufacturing activities.
- Complex legacy system migration required retaining critical custom SAP functionalities while modernizing infrastructure and ensuring regulatory compliance across global operations.
- Partnered with client developing comprehensive SAP CSV strategy aligning system with EU Annex 11 and GMP standards for international environments.
- Conducted detailed analysis of legacy system complexities. This led to retained custom SAP functionalities, the development of new features, and harmonization within global implementation plan.
- Created innovative custom tool identifying legacy custom objects in existing SAP environment enabling efficient risk assessment, mitigation planning, and CGxP-compliant content creation.
- Collaborated seamlessly with client internal teams and third-party vendors ensuring efficient coordination across global SAP rollout and comprehensive validation efforts.
- Implemented risk-based, process-focused validation approach prioritizing critical business processes and compliance requirements while optimizing resource allocation.
- Successfully consolidated six SAP instances into validated GAMP 5 system within aggressive timeline and budget constraints without interrupting enterprise operations.
- Delivered final validation reports and successfully validated legacy SAP system portions on schedule preventing potential project derailment and regulatory compliance gaps.
- Demonstrated effectiveness of Kymanox’s risk-based validation approach enabling proactive risk mitigation, improved delivery timelines, and significant cost reduction.
- Exceeded client expectations for complex multi-country SAP rollout through strategic planning, innovative tooling, and efficient cross-functional collaboration.
- Established scalable validation framework supporting ongoing system enhancements and future global expansion initiatives.