Are you considering SAP as a possible solution to your Enterprise Resource Planning (ERP) needs?
Do you need specialists experienced in meeting the needs of FDA-Regulated industries?
PSC proudly offers state-of-the-art SAP Enterprise Resource Planning Validation Services designed to meet your specific needs.
PSC’s highly-trained and experienced computer systems validation consultants provide the technical expertise essential to successful SAP software validation in the BioScience, Pharmaceutical, Medical Device and Diagnostics industries.
PSC has the regulatory expertise to configure your Quality Management and Controlled Documentation programs to meet your domestic and international business needs and meet the expectations of the regulatory authorities you have to deal with.
PSC has configurable validation services that can address all or part of your specific installation and are usually organized in the following manner:
Design Qualification (DQ) – This usually includes Risk Assessment, generation of a Master Validation Plan, Supplier/Vendor Qualification, and verification of User Requirement Specifications. These elements together comprise the Design Qualification Documentation package.
Installation Qualification (IQ) – This includes the IQ Protocol, the IQ Execution (or installation configuration verification) and the IQ Final report.
Operational Qualification (OQ) – This includes a solution-specific OQ Protocol that will address the standard and custom software configurations implemented, operator training, and the individual unit and integration unit testing. The results of all these verification activities are included in the OQ Final Report.
Performance Qualification (PQ) – This will address the system Change Control Program and the System Acceptance Testing results. This is a mock “Go Live” testing regimen that uses staged data to perform the actual business processes under dynamic conditions. The system is challenged with “worst case” scenarios to confirm the system is rugged and robust enough to take your business where you have planned for it to go. The results of all the Performance Qualification testing is compiled into a PQ Final Report.
Master Validation Final Report (MVFR) – This document is the overall culmination that proves your system is ready to “Go Live”. It includes the results of the DQ, IQ, OQ and PQ. It is the definitive statement regarding your system’s fitness for use.
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