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Real-Time Compliance Monitoring Software
It’s been two decades since FDA introduced 21 CFR Part 11 compliance for Electronic Records; Electronic Signatures. However, the regulated industry, specifically Life Sciences, is unable record automatic audit trails with perfection due to the evolution of disturbed technologies and the outsourcing.
We will send the white paper to the above mentioned Email ID.
Are computer generated audit trails still problematic for regulated industry?
With our extensive global experience working with companies of all sizes, we offer deep domain knowledge of FDA regulations and have a long track record of helping clients build effective compliance and risk mitigation strategies.
Xybion provides a total compliance and quality management solution for companies operating in heavily regulated industries. As part of this total solution, we offer ComplianceBuilder™, a unique solution that helps companies ensure they are properly monitoring all files, databases, and equipment in accordance with 21 CFR Part 11 and other regulations.
ComplianceBuilder is a cost-effective solution that provides compliance with minimal system and operator changes.
Xybion - Your Expert Partner