Compliance with 21 CFR Part 11 is one of the most important requirements for software that is to be used in regulated environments

In accordance with the FDA 21 CFR part 11 PLA has its own security infrastructure that requires users to log into the system. User accounts and their roles are defined with an easy-to-use interface. The accounts and their roles are database specific. In addition to this account management PLA is fitted with the full range of security options required by the 21 CFR part 11. The PLA Administrator can define security policies for each database in accordance to regulatory or your company’s need. The feature includes password complexity, password aging, password blocking and password history rules. You may also define inactivity locks to prevent unauthorized access to the system.

PLA 3.0 uses a variety of techniques to accomplish 21 CFR Part 11 compliance: