LNS Research recently published a great blog post on the State of the Market for Software Validation in Life Sciences. Click here to read the full post from Dan Jacob, Research Analyst at LNS Research.
With a primary focus on Life Sciences companies where computer system validation (CSV) is a requirement, Pilgrim Quality Solutions provides end-to-end support to validate SmartSolve®, our enterprise quality management software (EQMS) suite. All Life Sciences organizations must satisfy requirements for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) validation before rolling out new software systems or upgrading existing software systems, including EQMS. To support these requirements, Pilgrim provides published scripts for all system functionality, including each SmartSolve module. These scripts are updated and maintained with each release to ease the process of upgrading to new versions for our customers.
In addition, IQ and OQ validation is provided by our managed cloud services team for our Pilgrim Cloud customers as part of their monthly subscription. This eliminates countless hours of validation execution for our cloud-based SmartSolve customers. Our team of professional services consultants can also execute IQ, OQ, and PQ validation for on-premise deployments of our SmartSolve quality management solution—or PQ for cloud deployments—as a managed service.
We could not agree more with LNS Research that with automated validation the “the real value isn’t time savings, it’s the impact that these time savings have on the trade-offs . . .” or as we refer to these benefits, the real silver bullet.
Pilgrim has talked to many customers who struggle to find the resources to perform required validation or who need to expedite the process. Automated validation can provide a greater than 90% time savings while producing audit-ready artifacts in the process. Our experience has revealed that four weeks of manual validation testing can be reduced to less than eight man hours through automated validation. Extrapolate this efficiency across an entire global EQMS implementation and rollout, and it’s easy to see the true magnitude of value.
As Dan Jacob stated, some vendors “who truly understand the challenges are making big strides.” Pilgrim falls in this elite category of vendors who are solving its clients’ quality compliance management solution validation challenges—from fully documented test scripts, to automated execution of the scripts, to automated production of evidence documents.
At our biennial Fusion customer conference in April, we showcased our automated validation tool for SmartSolve applications. With Pilgrim’s Automated Validation tool, combined with its managed services, one of the huge constraints in system implementation or system upgrade—testing and validation of the system—no longer needs to be the barrier to clients unlocking the full potential of the solution.
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