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Author: roqmetrics

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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  Governance   Governance is the process whereby organizations make important decisions, determine who needs to be involved in processes, assign accountability, and assess compliance. It is important to note that governance is not management. Instead, it is the high-level planning and control of activities. This is a critical and essential distinction. Although governance deals with decision-making and decision-makers, it does not specify or make decisions for decision-makers....

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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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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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