White Papers for Food and Drug Administration (FDA)

Bringing UNIX/Linux Networks into FDA Regulation 21 CFR Part II Compliance with Symark PowerPassword, User Management Edition and Symark PowerBroker

Symark

This document addresses the use of Symark’s PowerPassword-UME and PowerBroker software to meet FDA requirements for stringent controls over electronic data and signatures. Symark PowerPassword-UME and PowerBroker safely delegate administrative privileges (including root)and implement secure logins and strong passwords. This document demonstrates how Symark PowerPassword-UME and PowerBroker work in tandem to protect the integrity of data across heterogeneous UNIX/Linux systems to help bring your system into compliance with FDA Regulation 21 CFR Part II requirements.

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