Ensuring Seamless Validation for Enhanced Data Analysis

In the realm of pharmaceutical technology, companies strive to leverage leading-edge data analytic tools to enhance their operations. A biotechnology company, seeking to expand its data analysis capabilities, embarked on a journey to integrate and upgrade its JMP Scripts, engaging two top-tier vendors.

However, to achieve full operational efficiency, these scripts needed thorough validation. Without the internal resources or expertise in validation, the company turned to Osprey Life Sciences, a leader in providing comprehensive IT solutions, for assistance.

The biotechnology firm faced a dual-layered challenge. First, the introduction of a new vendor for JMP Scripts, alongside an upgrade of the existing scripts, necessitated a robust validation process to ensure operational integrity and compliance. Second, the organization lacked internal capabilities in conducting this meticulous task, specifically needing guidance on maintaining the platform’s validated state and keeping audit compliance in check.

Ensuring that these scripts were seamlessly integrated into their operational platform while being compliant with GxP standards was crucial. Additionally, it was imperative to develop a streamlined process to manage risk assessment, testing, and approvals without sacrificing quality or speed.

Osprey Life Sciences was entrusted with delivering a robust end-to-end validation solution tailored for this biotechnology company. Recognizing the need for a comprehensive approach, Osprey set to work by first gaining an in-depth understanding of the JMP Platform and the scripts involved through detailed discovery sessions with the client.

Osprey crafted a series of well-defined steps:

• Authoring the Validation Plan: Osprey developed a meticulous plan, outlining each phase of the validation process.
• Risk Assessment: A straightforward tool was provided, allowing the client to evaluate project risk effectively.
• Guidance on Audit Compliance: Clear protocols were laid out to ensure all processes remained audit-compliant.
• Execution of Test Scripts: This involved running each script meticulously while capturing objective test evidence using Osprey-created templates.
• Documentation: From the test scripts to the Validation Summary Report (VSR), every asset was documented and routed for necessary reviews and approvals.

It was essential to establish the business partner role in the patient safety department, providing not just internal technical solutions and standards to the department, but also increased awareness of patient safety requirements and operations across the BIS organization.