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MasterControl's FDA 21 CFR Part 11 Compliant Quality System MasterControl has developed state-of-the-art document control and quality management solutions that are 100% compliant with FDA 21 CFR Part 11 regulations. MasterControl's solution features provide the following benefits: Part 11 Section ...
21 CFR Part 11 Compliant Comply with regulatory requirements when creating, storing, and managing GxP-regulated documents. Native support for audit trails, checksums for data integrity, and robust access control deliver a simple yet effective path to GxP and 21 CFR Part 11 compliance. Easy to Imp...
PharmaReady ™ FDA Compliant Document Management System Title 21 CFR Part 11 cross-reference 21 CFR Part 11 RequirementSolution, Pharmaready
The EL-WiFi-21CFR-DULT is a dual channel 21CFR Part 11-compliant Cloud-enabled wireless ultra-low temperature data logger, with a built-in display, designed for monitoring vaccines in ultra-low temperature dry ice storage. The measurement range is -100 to +100°C (-148 to +212°F) usin...
Part 11. It enables users to create complex barcodes such as the 2D DataMatrix barcode, Health Industry Bar Code (HIBC), GS1 Databar, and more. Ensure a secure and compliant process by establishing user permissions and applying electronic signatures to your labels throughout their entire ...
Our Automation Team at BiOZEEN ensures user friendly operations which are 21 CFR Part 11 ready, in the highly challenging Biopharmaceutical production space
This whitepaper discuss why standalone instruments cannot be 21 CFR Part 11 compliant and the importance of ensuring reliable electronic records and electronic signatures in computerized systems.
FDA 21 CFR part 11 compliant label software, TEKLYNX CENTRAL CFR is your software solution for label design, label printing, and label tracking.)
SliceVault makes it easy to transfer store and share CFR Part 11 compliant medical images in clinical trials.