21 CFR Part 11
Electronic Records; Electronic Signatures

A common misconception is that a product is "21 CFR Part 11 Approved". Often customers inquire as to whether our Nexygen software is approved under 21 CFR Part 11 guidelines.

Our Nexygen MT Series software includes a Security Module that helps users comply with 21 CFR Part 11 guidelines. It allows users to integrate the Nexygen MT product and testing system into their overall quality procedures, quality processes and system environments. The Security Module "assists" users in meeting these guidelines by providing functions that adhere to the objective of maintaining security and integrity of electronic records and signatures. These functions include: audit trails, time stamps, general security and archiving.

NEXYGEN Series software products are TickIT accredited.