STARLIMS Validation


The Challenge

A pharmaceutical manufacturing company implemented a Laboratory Information Management System (LIMS) to electronically maintain their sample inventory, workflows, and laboratory information. The LIMS would collect, store, and report data and maintain FDA GxP and 21 CFR Part 11 compliance.

Initially, the client hired Performance Validation (PV) to conduct the vendor-supplied validation test scripts as resource support since their validation department was short staff. The vendor documentation was going to be used in conjunction with the client’s validation SOPs and templates to validate the LIMS.

The PV Advantage

After an initial review of the vendor’s test scripts, it was determined that it would be a lengthy task that would negatively impact the client’s timeline. PV was able to leverage its experience and suggest that a risk assessment be performed to focus and reduce the amount of testing needed. The risk assessment provided a means to determine if the functional testing of all the “out of the box” features in the LIMS system was necessary or if the client could concentrate on high-risk functionality and configured features.

The client and PV jointly performed a risk assessment utilizing the GMP Risk Analysis method. The risk assessment results provided evidence that the vendor had been evaluated, and their Quality Management System provided confidence that not all functionality needed to be formally tested, including out-of-the-box functionality. Additionally, testing could focus on configured and customized items in the software which were deemed GMP critical. The GMP criticality was determined for each item in the vendor-provided Functional Design Document and was documented in the client’s risk assessment. As determined through the risk assessment results, the company was able to pivot from the vendor test scripts and concentrate their validation focus on their GMP critical functionality and configured workflows.

Both the PV employee and client employee participated in the LIMS vendor training before the start of the effort. From there, the PV employee worked closely with client employees to understand the company’s workflows and how they would be captured within the LIMS system. The first workflow to implement was both the raw material and finished product receipt of controlled and non-controlled substances and then the laboratory’s distribution of samples for testing. Ensuring the accountability of controlled substances was a critical focus area as they are closely monitored and audited by DEA. PV ensured the validation covered the use of witness signatures at significant points within the LIMS system for these substances. PV used the client’s draft work instructions and several demos to develop test scripts and identify gaps. PV then performed dry run testing, communicated issues, and confirmed their resolution. Once the validation environment was ready, PV remotely executed the formal testing.

The second workflow to implement was entering laboratory test results, which are then reviewed by a second party and released by a third party. Both non-controlled and controlled substance workflows were addressed to ensure compliance. PV developed the test scripts, and the formal execution was put on hold for the holidays. However, while the client resources were out of the office, a request from upper management to complete the testing by the end of the year was received. The client reached out to PV to help, and the PV employee worked to execute the test scripts and complete the final report, which was usually authored by the client validation lead. Since PV was able to step in during this crunch time, it allowed the client to meet their deadline for implementation while critical resources were out of the office.

The third workflow to implement was integrating lab equipment within the LIMS and developing and testing custom ELNs (Electronic Laboratory Notebooks). The PV employee reviewed instrument manuals, client work instructions and had the client perform demos using cameras to see the instruments in the lab to develop test scripts. PV also analyzed the ELNs to identify any gaps with data auditing that could occur when going from handwritten logbooks to electronic capture within the LIMS. Testing efficiencies were also determined so as not to repeat testing on configurations validated previously and used in subsequent ELNs. Testing lab-integrated equipment was performed utilizing Zoom cameras with client personnel in the lab and the PV employee working in the LIMS remotely.

The Results

PV and the client developed a successful partnership and implemented several workflows and GMP critical functionalities within their LIMS system. PV was able to guide an effective and efficient approach to the validation effort utilizing a risk-based approach. PV was able to jump in and help with unexpected, additional tasks when needed to ensure the client met their timelines. PV was able to provide validation guidance, identify gaps and ensure compliance through all project stages. Due to the positive feedback from the client, PV’s contract was extended to ensure PV is available to help with the additional instrumentation integrations and ELN development within the subsequent phases of the client’s LIMS adoption. In addition, a new effort to assist with developing SOPs for the client’s Periodic Review effort was added to the scope of work.

The Benefits

Performance Validation provided the client with peace of mind knowing that PV will do what is necessary to ensure that timelines can be met and that a quality validation will be conducted. Performance Validation’s experience with risk-based testing and LIMS implementation helped the client focus on the system’s critical components and streamline the validation process. Performance Validation produced deliverables per the client’s SOPs and templates and provided the expertise to develop new SOPs. The Performance Validation resource became an integral piece of the client’s internal validation team as they strive to meet their LIMS implementation goals.