Stanley Curtis, CTO and Senior Vice President, Software Engineering, Pilgrim Quality Solutions
It’s time to put down your pen and paper. Stop hoarding the mounds of paper artifacts that result from manual Computer System Validation (CSV). Free up your valuable resources for other operational tasks while safeguarding the results of your CSV. All of this is possible with automated and paperless validation tools for software validation.
The FDA requires computer systems validation for any software-driven components built into medical devices, or software used to design, build, or manufacture medical devices. The same holds true for software used in the manufacturing of pharmaceuticals, biologics, or other products or components for Life Sciences. Amazingly, some companies—large and small—still perform validation manually.
An era of ubiquitous automation
Software automation is all around us in every aspect of our lives, including airplane flight controls, ERP systems, navigation systems, and robotics. And, with the rise of the self-driving cars now, the car beside you on the highway may not have a human driver.
Moreover, automated software testing has been used widely—and successfully—in the software development world for decades to improve the quality of very complex software systems. There are many frameworks available and in use today for automated software testing, including commercial tools such as Microsoft’s Coded UI and open source tools such as Selenium.
The new genre of automation in software validation
Pilgrim Quality Solutions’ SmartSolve® Automated Validation uses Microsoft’s tried-and-true Coded UI framework which emulates a user performing the validation of Pilgrim’s SmartSolve suite of products on a live system. Automated Validation runs with minimal user intervention and generates the appropriate system-generated electronic artifacts required to show the objective evidence of the validation process and results.
The artifacts include screenshots documenting each action and the corresponding results of each script step and video. This provides an exact and accurate history of the software validation process. All of the audit-ready artifacts are stored electronically in secure PDF format for future retrieval and review when necessary.
Using automation, Pilgrim’s validation services significantly reduce the cost (both time and resources) to validate the SmartSolve suite of products. Compared to the more traditional manual method, Automated Validation also enhances the accuracy and quality of the SmartSolve software validation process, and the resulting artifacts.
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