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Data Integrity &
Data Integrity &
21 CFR Part 11
Trusted data. Reliable decisions.
We help you establish and maintain
data integrity and electronic record
controls in compliance with
21 CFR Part 11 and GxP requirements.
- Audit TrailsAudit TrailsSecure, time-stamped, computer-generated records of who did what and when, so every change to GxP data can be traced and reviewed.
- Electronic
SignaturesElectronic Signatures21 CFR Part 11 compliant signatures that are unique to each person, linked to their records and as binding as handwritten ones. - Access
ControlsAccess ControlsRole-based permissions, unique user IDs and password policies that make sure only authorized people can view, create or change data. - Record
RetentionRecord RetentionKeeping complete, accurate records readable and retrievable for the full required retention period, with backup and archival controls.