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Software Validation Services: IQ/OQ/PQ Execution

Managing the computer system validation (CSV) process is often an in-depth project with many steps to completion. From authoring, executing and reviewing IQ/OQ/PQ software validation scripts, to controlling documentation of your validation process and artifacts, the end-to-end project can require hundreds of hours of tedious, detailed focus. That’s why Pilgrim is here to help. When it comes to computer IQ/OQ/PQ software validation for SmartSolve®, we’ve got you covered with an option to ease the validation burden.

Managing the Validation Process

Pilgrim’s managed services team can handle the end-to-end process of validating your SmartSolve quality management software applications by leveraging our platform-based Automated Validation processes. From installation qualification (IQ), to operational qualification (OQ), and even production qualification (PQ) of SmartSolve, our teams serve our customers’ validation needs. With every SmartSolve release, Pilgrim authors the respective IQ and OQ scripts, and through Pilgrim’s Automated Validation and QA processes, fully executes these on behalf of our Cloud customers before general availability of each release. Customers can be confident that they will be audit-ready when they engage Pilgrim’s OQ scripts to create their own custom-tailored PQ scripts – whether performed by their own customer-led teams or by Pilgrim’s managed services teams – using the very same processes Pilgrim uses to validate the standard release.

Automated Validation

Our proprietary SmartSolve Automated Validation tool delivers OQ validation execution of SmartSolve solutions at a reduced timeline, enabling your team to focus on what they do best—manage quality processes and produce high quality products. Automated Validation is offered as a managed service from our Professional Services Team. Pilgrim’s Automated Validation services features system-generated output of evidence artifacts, including screenshots at each step in the script. You receive compliance-ready documentation of the user emulation of the system.

Manual Computer System Validation

Our SmartSolve experts also offer script authoring and execution services for IQ/OQ/PQ. They can write PQ scripts based on your business requirements, then execute them to ensure the system is functioning as documented prior to full production use of your SmartSolve quality management software applications.

 

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