The Challenge

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:

1. PV created a Validation Plan to outline the validation deliverables and the strategy for qualification testing. This document included:
2. A System Risk Assessment was performed and documented following the ISPE GAMP 5 Guide. The software was assessed as a GAMP Category 4 (configured software), with low risk for both likelihood and severity of system component failures. Based on the results of the assessment, PV was able to right-size the qualification phase to focus on testing of standard workflows and configured functionalities.
3. 21 CFR Part 11 compliance assessment.  PV understood the regulations for the FDA Guidance and the assessment outlined areas of the software that needed to be addressed with a procedure (i.e. gaps) and was also used to create user requirements. A summary of how the gaps were addressed was also generated to include with the validation package.
4. PV created a Requirements Specification document.  The document was develop based on phone calls with the client to describe their business processes.
5. Requirements were developed over several rounds of stakeholder reviews and updates. The PV team’s extensive years of experience in writing requirement documents for computer systems enabled them to write testable, concise requirements.
6. PV generated drafts of the test protocols by working on screen sharing calls with the SME to create test scripts in a manner that ensured that the testing would be reproducible.
7. PV provided regular project status updates on progress of the validation deliverables, project budget, and risks to the project and schedule.
8. The team delivered a Validation Summary Report to record the delivery of all the planned validation deliverables and to detail how the clients’ documentation satisfied regulatory requirements.

The Results

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.

The Benefits

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.