KELA

KELA specializes in the manufacturing and worldwide sale of both veterinary and human pharmaceuticals, as well as nutritional supplements. KELA’s success has been built on the high quality of its products, its highly regarded customer service, and overall operational reliability.

CHALLENGE

KELA decided to replace its legacy, mainframe-oriented system with SAP ECC 6.0. and, situated in a Good Manufacturing Practice (GMP)-critical environment, needed a partner with SAP validation expertise to implement it in a compliant way. The solution needed to allow the company to successfully meet compliance and validation requirements and pass applicable regulatory agency inspections.

SOLUTION

CTG applied a scalable, risk-based validation approach in order to steer and focus the validation effort using the outcome of the GxP Criticality and Risk Assessment, software categorization according to GAMP5, and supplier documentation. KELA realized a significant reduction of the validation effort, and thus cost savings for validation, by applying this risk-based approach. CTG provided best practices regarding SAP compliance, including GxP Criticality and Risk Assessment, authorization approach, EU Annex 11 controls, and supporting procedures.

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