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Validation

Tailor-made for Life Sciences, ValidateMyApp is a 100% paperless platform to manage the full GxP computer system lifecycle. As a GxP implementation project manager, you need to communicate the status of your projects and the progress it's making toward milestones to a wide variety of stakeholders from functional SME's to executives, each with varying levels of information needs. While your development team wants to manage the...

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Conference Highlights   Being a Gold Sponsor of the KENX Computer System Validation and Data Integrity Congress, it's both our honor and responsibility to share highlights from the event. The conference was attended by life sciences industry leaders, experts and professionals from across the globe.   The KENX Computer System Validation and Data Integrity conference held in Philadelphia, PA, December 9th - 11th, was packed with lots of great...

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Simplify the Computer Systems Validation process with ValidateMyApp. It's not just electronic. It's smart too! Want to learn more? .button { background-color: #4CAF50; border: none; color: white; padding: 20px; text-align: center; text-decoration: none; display: inline-block; font-size: 16px; margin: 4px 2px; } .button1 {border-radius: 2px;} .button2 {border-radius: 4px;} .button3 {border-radius: 8px;} .button4 {border-radius: 12px;} .button5 {border-radius: 50%;} Request a Demo ROQMetrics, Inc, 701 E Santa Clara...

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Enrich your computer system validation efforts with ROQMetrics professional services. Assessment   Assessment of your current state GxP system for adherance to 21 CFR Part 11, good SDLC practices and more.   Project Management Management of your compliance projects to assure your projects stay on track and implemented efficiently while meeting business and quality objectives. Timeline Budget Risks Isues Etc.   Validation   Manage the validation of your compliance projects to assue that solutions are implemented in compliance with regulations...

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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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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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