A-S 21 CFR Part 11 Toolkit

Aitken Scientific have created a software product called A-S Login (fully validated to GAMP standards) which will enable the pharmaceutical industry and its suppliers to minimise cost and time when implementing the requirements of 21 CFR Part 11.

• Maintains permitted applications, allowing versions and access rights to be controlled.
• Maintains the list of authorised users
o Password administration
o Full user administration.
• Provides simultaneous login limits for users and applications.
• Attaches rights to users to allow them to use features within each application.
• Record change made to the database by the administrator console.
• Provides comprehensive login history and audit trail
• Provides a centralised registry feature where applications can save their system wide settings.
• Maintains local settings relating to passwords, application settings and other audit information.
• Provides a feature to read high priority events which may have been logged.

A-S login provides complete 21 CFR Part 11 compliant user login functions, and a comprehensive administrator console. The software routines in the product can be called from Visual C++, Visual Basic and Delphi applications, and uses complex encryption and check summing techniques to protect data from accidental or deliberate falsification.

The software is available in the form of a Software Development Kit. The one-off cost of a development licence allows multiple applications to be built, and there is no on-going licence needed once you ship your application.

Example programs and documentation are supplied to ease the task of understanding how to use the software. In addition, Aitken Scientific can supply expertise to assist companies when building Part 11 compliance into their applications.

The software satisfies the requirements of the regulation when applied to "closed" systems only, and does not use biometric methods for user identification.

Call us to discuss your requirements.