SAP / ERP Validation
ERP software validation is the process of documenting every possible outcome given known inputs.
The relevant FDA regulations concern if an ERP function can affect the efficacy, potency, safety of a produced drug or device, then the ERP itself is deemed a medical device and must be tested and validated
The ERP implementation deserves full attention from top to bottom and needs to be considered as a separate project. Many modules are available in SAP ERP but generally Finance (FI), Controlling (CO), Material Management (MM), Production Planning (PP), Sales and distribution (SD), Plant Maintenance (PM), Quality Management (QM), Document Management System (DMS) & HR with Payroll are most preferable.
The functioning of these modules needs to validated to ensure the correct values and workflows
Validation Steps:
Following are the general basic steps involved in the Validation processes of SAP / ERP
1. Gap Analysis: GAP here means incompleteness or missing links. GAP analysis means analysing the SAP/ ERP system through available documentation, and current status of SAP / ERP with reference to the guidelines of regulatory agencies and attempt to find out from available implemented systems. The checklist prepared in GAP analysis has current requirement defined as acceptance criteria.
2. Plan of action: Based on the gap analysis organisations can create action plan along with client, and decide which gaps can be closed technically and which are to be attended by other procedures.
We employ the SAP / ERP validation in accordance with the GAMP 5 protocol. SAP is the world leader of ERP provisions with a significant computing heritage. Our experts are also capable of GAMP 5 validation in Microsoft Dynamics, and Oracle Enterprise Resource Planning operations. Whether you need internal validation or the full spectrum covering both external and internal validation, we are here to assist. We also ensure the provision of adequate training backed by effective documentation to assist administrators in executing granular control over the elaborate system processes.
