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CSV

Conference Highlights   The KENX Computer System Validation and Data Integrity conference held in Philadelphia, PA, December 9th - 11th, was packed with lots of great content and interactive workshops from preparation for FDA computer systems inspections to cutting edge topics like machine learning and artificial intelligence. There were so many compelling competing topics; it was hard at times to choose which one to attend. The good...

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A computer system validation strategy to help define your success ROQMetrics has a proven approach to help you digitally transform your computer system validation (CSV) process. We work with you to develop a holistic computer system validation strategy that connects quality and compliance goals to your IT architecture. ROQMetrics experts will help you get the most out of your digital CSV transformation using...

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          Computerized System Validation       Computerized system validation (CSV) is the documented process of assuring that a computerized system works as intended in a consistent manner. The validation process begins with the system requirements definition and continues until system retirement and in accordance with e-records regulatory retention rules.       The FDA requires the following types of software systems to be validated.       Software used in the production of products under FDA regulation. Software used...

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GxP Software Vendor Audits Choosing a software vendor for your GxP processes can be daunting. Knowing whether the vendor can provide a high-quality product, protect your data, and provide timely support and services can keep you up at night. And now that many GxP software vendors are embracing cloud platforms you are faced with additional shifts in risk. These risks are...

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Enterprise Collaboration Enterprise collaboration allows cross-functional subject matter experts to communicate on topics across and beyond their immediate team. Common CSV Collaboration Points The most common use of the ValidateMyApp Enterprise Collaboration functionality is to collaborate on Artifacts. RequirementsProtocolsProtocol ExecutionExceptions & DeviationsEtc…. Key Collaboration Capabilities FeatureDescriptionGroup CollaborationCollaborate with a specific group of people such as your project team.Process CollaborationCollaborate around a specific record of data, for example, an artifact such as...

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What is a heat map? A heat map is an immediate summary of information presented in a matrix where values are represented by colors. Heat maps are a great tool to quickly identify areas of concern such as gaps in requirements or testing and scope creep. Let's get visual! There are two levels of heat maps in validateMyApp. Artifact Heat Map The artifact heat map represents the status...

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What is an artifact dependency? A validation suite contains many artifacts, and the order of processing approvals is critical. For example, if you approve functional requirements before user requirements, you likely have a problem in your process. This order of execution issue is usually apparent by reviewing effectiveness dates on artifacts. In this case, the effective date of the functional requirements artifact is before the effective...

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What is traceability? The intent of requirements traceability is to ensure that no functionality is missing from testing and to prevent scope creep. Prevent scope creep you say? Yes, if you find that you have a test case for functionality that doesn't trace to a requirement, then you've obviously encountered scope creep. This means you need the ability to trace backward as well...

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