- Genesis computer software how to#
- Genesis computer software verification#
- Genesis computer software software#
If you didn’t get a chance to read the first write-up on how to accelerate CSA adoption, click here.
Genesis computer software software#
This blog is the second of a three-part series focused on FDA’s Computer Software Assurance (CSA) initiative. Wide support network to assist clients across the globeĪ talented, well qualified team - the backbone of our success Working with life science organizations, including several Fortune 500 companiesīuilding on the strengths of partners to add significant value to services and solutions See what clients say about our suite of validation services and solutionsĪccess our library of educational white papersĪccess our library of educational videos on validationĪ global organization established in 2005 in South San Francisco, CA
Stay informed and up to date on hot topics and current eventsĬheck the calendar of events we are attending this year Quickly release new versions/ service packs with our test automation enginesĪ quick snapshot of our library of resourcesĬheck for the latest information from our newsroom Single environment requirements management, simplifying proof of complianceĪchieve standardization and data integrity via seamless processes Seamlessly manage Design History Files (DHF) across all units and sites Manage critical validation, quality/regulated data and documents in the secured cloudĬonsistently meet Blood Establishment Computer Software (BECS) RequirementsĮnforce approved validation plans to be audit-ready without preparationĮnsure data integrity and get organized with automated audit trails
Genesis computer software verification#
Verification and review (with e-signature) of equipment logs at point-of-needĭata captured from equipment is plugged into all documentation/evidenceĪccommodate every change while maintaining validated statusĪddressing critical technology elements for any life science enterprise IoT capable validation for temperature controlled supply chains
Risk-based commissioning and qualification process Seamless connectivity across process, data, and knowledge management Integrated, seamless lifecycle process across multiple groups and sitesĮrror-free, paperless, integrated analytical method lifecycle validation Quick access to data and validated state of equipment Plan and execute the entire process with required quality gate checksĪn overview of ValGenesis's Paperless Validation Software SolutionsĮrror-free, paperless, fully automated lifecycle management process Record, verify, and review logs as per approved SOPs/standards Track and efficiently manage any type of change request Identify and manage the review schedules of validated GxP systemsĮvaluate and control risk at functional and/or system levels Reduce execution time by up to 90% by removing human errors Identify and fix defects related to important requirementsĮxecute test cases quickly and securely, anywhere at any time Track documentation from design to change management and validation Manage change requirements as a closed loop validation process Manage complex validation projects with required quality gate checks Maintain a consistent approach across all validation processes and sites Manage the lifecycle of GxP assets with a documented audit trail An overview of ValGenesis's Validation Lifecycle Management System (VLMS)
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