Compliance to 21 CFR Part 11 - Electronic Records and Signatures |
Web based ValGenesis System is a world class validation automation and tracking system. ValGenesis facilitates the test scripts development, online reviews and approvals of test scripts will be handled through configurable workflow. ValGenesis can be utilized for online execution of approved test scripts with handling of deviations, online reviews and approvals of test cases will be handled through configurable workflow.ValGenesis generates barcode for the validated entities for the identification and tracking. ValGenesis System can be used to generate the validation number, track the validation status of all GxP systems/instruments/equipment corporate wide in all sites. ValGenesis keeps the validation methodology consistent across all departments and company sites - something the FDA recommends for any multi-site rollout. It provides the controls and auditing for compliance with regulatory requirements such as 21 CFR Part 11.
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