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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.

Automatic audit trails are directly related to record integrity. As such, electronic records from computerized systems without automatic audit trail functionality are viewed as lacking integrity.

On addition, many systems used by the pharmaceutical industry are developed for general use by many different industries, and are not designed to provide the specific audit trail functions required by the FDA.
This white paper helps analyze the problem areas in tracking the audit trails and how the challenges can be mitigated through real-time monitoring solutions. Learn more.

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We will send the white paper to the above mentioned Email ID.

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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.


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