A medical supply company was audited and found their enterprise resource planning (ERP) software system Sage 100 needed to be validated since it creates quality records for the client. The customer used it only for Sales Orders and Vendor Purchases, so the entire software application did not need to be validated. They planned on implementing the Sage 100 platform as a SaaS (Software as a Service) with a browser-based interface.
The company contracted Performance Validation (PV) to create a Computer System Validation (CSV) package for their new system. The company had no experience with Computer System Validation and needed assistance with creating supporting documentation. At the client’s request, PV worked remotely to develop documentation validating the appropriate modules they planned to use.
The PV Advantage
PV established reoccurring meetings with the client stakeholders to gain information for the creation of a validation plan and completion of a risk and 21 CFR Part 11 assessment. Several phone calls and emails were used to create core documents and assist with writing a system specific SOP. After completing this documentation, the PV team began using screen sharing meetings to write test protocols to ensure adherence to the client’s timeline for implementation.
The following components detail the PV solution:
The ERP validation was completed ahead of schedule, meeting the customer’s desire to resolve the audit findings in a rapid manor. The company gained awareness of gaps in their procedures and security and resolved them. PV completed the validation effort by practicing excellent documentation standards, testing processes, and a focus on the customer needs. This medical device company now has a cGMP ERP system that is compliant with FDA regulations for computerized systems.
Performance Validation provided the client with consultation through understanding the software, the stakeholders and their needs, and proposing the best fitting validation strategy for an Enterprise Resource Planning solution. Performance Validation’s experience with validating SAGE helped expedite the project.