A Fortune 200 life science organization needed to convert six separate SAP instances into one GAMP 5 multi-country, multi-site, validated system with no disruption to on-going enterprise and with an aggressive timeline and cost allowances. The project also needed to be accomplished in alignment with the SAP International vision and thus harmonized into a single global instance.
- Kymanox® partnered with our client to create a full SAP Computer System Validation (CSV) that incorporated the following:
- Alignment with Annex 11 and GMP standards for the International SAP Environment
- Assessment of Complexities from Legacy Systems and Data
- Retainment of Legacy Custom SAP functionality
- Development of New Functions
- Harmonization with the client’s overall Global SAP Implementation Plan including disparate international sites, systems, and unique data elements.
Consolidating multiple SAP instances into one GAMP 5 validated system with no disruption to on-going enterprise and with an aggressive timeline and cost allowances.
Created custom tool to identify the legacy custom objects in the existing SAP system using the SAP transactions that were documented as part of the business process. This allowed Kymanox to assess the risk and determine an appropriate mitigation as well as create CGxP compliant content.
Kymanox delivered final reports, validated the legacy portion of the new SAP system within budget, and kept the SAP implementation on schedule which was in danger of being derailed. The project’s results demonstrated the value of the Kymanox approach and expertise: Kymanox - Risk-Based and Process-Focused approach (Proactive early phase risk mitigation, Improved project delivery time and reduced implementation cost), Efficient collaboration with client and 3rd party teams on complex SAP Multi-Country SAP Global Roll Out & Annex 11 Validation Effort, and Kymanox Subject Matter Expertise coupled with rapid custom solutions development exceeded client expectations.