The Challenge

A medical technology company with no previous Computer System Validation (CSV) experience needed to complete the validation of their Global Shop Solutions (GSS) enterprise resource planning (ERP) computerized system in accordance with 21 CFR 820 (FDA Quality System Regulation) and 21 CFR Part 11 (Electronic Records, Electronic Signatures). The ERP software would be used for the client’s Sales orders, Purchase Order Processing, Production Scheduling, Inventory Management, Accounting Activities, and Item Maintenance. In addition to the CSV work, new, integrated equipment was being qualified. The ERP validation would be running in parallel with the equipment qualification, and some of the equipment was dependent upon the ERP validation completion to finish. The client had a goal for a specific number of quantities built, tested, and in the Finished Goods Inventory before FDA Clearance which further defined the timeline.

The PV Advantage

Because of Performance Validation’s (PV) experience across multiple validation platforms, both the equipment qualification and the CSV effort were managed by resources within PV. This allowed for ease of communication between the equipment and CSV teams to ensure documentation was aligned and adherence to timelines.

To start the CSV effort, PV first drafted the Master Validation Plan (MVP). PV has a set of templates for standard validation deliverables, which were modified to resemble the client’s current SOP format to allow for seamless inclusion of the validation documents. PV performed an initial assessment to confirm the ERP required validation for the MVP and then determined it was classified as SC4 within the GAMP 5 classification. This meant the functions that the client configured would be tested more rigorously than those that are Commercial-off-the-shelf (COTS). Testing would focus on workflows and daily functionality while minimizing the testing of every software function. A Data Integrity Assessment and 21CFR11 Assessment were also performed to determine any gaps within the client’s processes or the software that needed to be addressed to maintain compliance.

Upon completion of the plan, the User Requirement Specification (URS) was drafted to capture the system’s intended use and any compliance requirements noted in the MVP. In addition, the client had put together a series of work instructions and videos to aid in training their employees on the new system. PV was able to use these to identify the essential requirements that defined their intended use and draft the test scripts for each requirement according to their expected process. Once the requirements were captured and the test scripts drafted, the PV resource could remotely dry run/informally test the system using the test scripts. Throughout this process, the PV resource worked closely with the Director of Operations to identify gaps in the work instructions, identify missed requirements and refine the test scripts. This provided a more robust URS and removed test script errors which aided in streamlining the formal testing.

Gaps that PV had identified included missing directions within the client’s process and missing functionality within the current software setup for 21CFR11 compliance, specifically user access, security controls, and audit trail. PV worked with the client to define processes utilizing the current ERP functionality to establish user groups to enhance security and access controls. Additionally, PV guided using existing product traceability functionality within the software that covered their current needs to ensure audit trail compliance. Finally, future updates were discussed to enhance the software’s ability to provide a more comprehensive audit trail functionality.

After formal testing, the Validation Summary was drafted to document the testing details and close the loop with the client SOP updates that covered the gaps identified during the validation effort, including the change control process for a validated system when future updates were implemented.

The Results

Due to the effort and collaboration with the PV CSV and equipment qualification resources, the validation was completed per the client timelines for FDA clearance for their products. PV’s experience enabled them to develop a comprehensive and targeted ERP validation. PV was able to identify gaps in the client’s security processes and ensured procedures were in place as a means of resolution.

Also, PV identified and documented compliance for the audit trail utilizing existing ERP functionality and provided direction for defining the change control process for when the ERP system was updated.

The Benefits

Performance Validation provided resources with different expertise to target the multiple validation efforts common with large projects. PV could leverage and improve upon the client’s existing work instructions to define the intended use requirements and test steps. In addition, PV’s experience and familiarity with the regulations allowed them to guide how to adhere to security requirements and provide justification and work around to address the client’s 21CRF11 compliance gap within the ERP system.

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