Chapter 21 Part 11 Compliant Enhanced Security Module for Exponent Software
SECURE YOUR INFORMATION IN EXPONENT SOFTWARE - - APRIL 2004
Developed in accordance with the FDA CFR21 Part 11 guidelines, the EXP/ESM Enhanced Security Module for Exponent software - the dedicated software for use with the TA.XTplus and TA.HDplus Texture Analysers - has been introduced to provide electronic record and signature management.

It offers the user features to improve the security of their and their customers' information, as well as facilitating continuous monitoring and tracking of results and records. Features include an encrypted log-on password of at least seven characters, combined with password protection for validation of calibration checks. In addition, multipe hierarchical levels of user profiles are available and electronic signatures can be used for record certification.

Another important feature is the ability to copy and print out audit trails, allowing clear visibility to trace results and records. The module also provides protective security measures to detect and notify any attempt at unauthorised use of passwords and/or identity codes during the audit.

ESM Main Features:

  • Lock program after predefined amount of inactivity
  • Send messages to a specified user or computer on detection of tampering.
  • Advanced logging of actions such as logging in/out, changing options, performing calibrations, etc.
  • Policies to create common security rights for groups of users.
  • Define the number of login attempts before being locked out
  • Specify lockout time if required
  • Specify password validity
  • Strict password checking option
  • Specify any unique passwords required before reuse
  • Option to force user to change password when they next login
  • Ability to display a custom reminder if the password is forgotten
  • Option to prevent user from changing their password
  • Option to disable a user account or temporarily prevent it from being used
  • Ability to log Check Force results with independent user verification.
  • Option to give individual users rights to verify actions such as calibrations

      Stable Micro Systems, the world leader in texture analysis equipment, has recently achieved ISO 9001:2000 Certification through the accredited body of SGS. The internationally recognised ISO 9001:2000 standard has been designed to result in continual improvement and customer satisfaction and replaces all current ISO certifications which expired in December 2003.

      ISO registration is a measure of reliability, consistency and commitment to quality supply. ISO 9001:2000 adheres to the original manufacturing and quality requirements of ISO 9001 but has now expanded its guidelines to encompass the role of communications between an organization and its customers. It defines the elements of organisation required by a company to achieve and demonstrate the necessary skills required to quality manange their activities, products or services, i.e. Managment responsibility, Resource Management, Product Realisation, Measurement, Analysis and Improvment.

      ISO 9001:2000 certification requires a lengthy and rigorous process that includes detailed systems and management analysis through documentation as well as internal and external audits. Stable Micro Systems developed and implemented a comprehensive program that assures compliance to ISO standards in all areas which will inspire the confidence of potential customers.