The Food and Drug Administration requires companies involved with pharmaceutical manufacturing to conform to Chapter 21 Code of Federal Regulations Part 11. These requirements state that electronic audit trails must be kept for all manufacturing or quality control activities.

The TA.XTPlus Texture Analyzer’s Exponent software with add-on module, Enhanced Security Module (or ESM), helps manufacturers keep their electronic texture analysis data collection and processes Chapter 21 CFR Part 11 compliant. The ESM module keeps track of when tests are conducted, when equipment is calibrated via calibration logs, test record logs, and offers different degrees of security for which users can audit, review, and delete test results.

Enhanced Security Module (ESM) for the TA.XTPlus Texture Analyzer (Exponent software version 32) is now available. ESM offers flexible user-level security controls and several other useful security features such as:

  • Password control of History, Attempts before lockout, Lockout time, Maximum Age, Strength, etc.
  • Policies for assigning rights to groups of users
  •  Logging of actions such as logging in / out, calibrations, etc.
  • Printing of calibration reports

You can specify if the user is an Exponent AdministratorManager or User:

  • Only Administrators can access the Security System Properties and Policies menus. The Disabled Menus options do not apply to Administrators.
  • Managers cannot edit properties of themselves, other Managers or Administrators, only other Users. The Disabled Menus options do not apply to Managers.
  • Users can only access their own policy to change passwords.

Drug researchers, although they are not required to comply with Chapter 21 CFR Part 11, can find that the ESM’s audit trail is invaluable when participating in the FDA review process for new drugs. Food and cosmetic manufacturers typically do not need to comply with Chapter 21 CFR Part 11 unless they are making a claim that their product provides certain health benefits. However they may voluntarily want to use Chapter 21 compliant equipment for its extensive audit and record tracking capabilities.

The latest version of ESM is now available. Please contact your local representative if you are interested in these features or would like to upgrade your Exponent software.