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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 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 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 for you. From installation qualification (IQ) to operational qualification (OQ) and even production qualification (PQ) – IQ/OQ/PQ — of SmartSolve, our services team can work for you. With every SmartSolve release, Pilgrim authors IQ and OQ scripts for our clients. If your business needs support for computer system validation outside the scope of enterprise quality management software (EQMS), for other solutions in your enterprise, Pilgrim partners with ValGenesis for paperless validation lifecycle management.

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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