Case studies

Real validation projects: which system, what regulatory scope, and how it ended.

Validation of SAP S/4HANA and WAMAS for a pharmaceutical manufacturer

A Central American pharmaceutical group launched a new company and a new plant with two systems that govern almost all of its processes with very little human intervention: SAP S/4HANA and the WAMAS WCS of the automated warehouse. OqoTech carried out the SAP rollout and upgrade and the full validation of both systems, and the documentation was later presented in an inspection by the Brazilian health authority with no applicable comments on the validation.

SAP S/4HANA (FI, CO, PPDS, PP, EWM, SD, MM, PM, PC, QM, HCM, DMS)WAMAS (WCS)GAMP 5

5proveedores GxPGxP suppliers documented and audited

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