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Text Content

REAL-TIME COMPLIANCE MONITORING SOFTWARE

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Designed to enable 21 CFR Part 11 compliance, providing data integrity across IT
systems such as file systems, database systems, laboratory or manufacturing
instruments.

We understand the complex, ever-changing regulatory environment and markets with
the challenges in healthcare, devices, and research industries to blend our
expertise with business acumen to provide innovative and compliant solutions for
various maturity levels of your organization.




AUDIT TRAIL

Generate an audit report based on specific data events, such as data creation,
deletion, or modification, and with login/log-out session with duration
information.


21 CFR PART 11 COMPLIANCE

Configure the meaning of e-signatures for data events through Picklist. This can
be monitored through an audit trail to prevent super users (like Admin) from
changing the choice of Picklist later.




EFFORTLESS COMPLIANCE

Compliance Builder manages your quality and compliance processes with full
integration of all core business processes including R&D, laboratories,
manufacturing, and testing on a single platform.


GENERATE AUDIT TRAIL AND ENABLE ELECTRONIC SIGNATURES

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TRUSTED BY THE MOST REPUTABLE BRANDS IN THE WORLD




ONE CLOUD PLATFORM, TOTAL DIGITAL TRANSFORMATION

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© COPYRIGHT 2024 XYBION CORPORATION. ALL RIGHTS RESERVED.





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