GAMP Validated 21 CFR Part 11 Validation Software Tool: A-S Login

If your company is using electronic signatures attached to electronic records, then the FDA regulation 21 CFR Part 11 applies to you.

Aitken Scientific have created a validation software tool 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. A validation software demonstration install set is available for download. Please contact us for the link.

21 CFR Part 11 compliant user login functions

The A-S login validation software tool 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 checksumming techniques to protect data from accidental or deliberate falsification.

The validation software tool 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 validation software tool. In addition, Aitken Scientific can supply software engineering expertise to assist companies when building Part 11 compliance into their applications.

The validation software satisfies the requirements of the 21 CFR Part 11 regulation when applied to "closed" systems only, and does not use biometric methods for user identification.

The A-S Login Validation Software Administrator Console

The administrator console is a feature rich Windows application which manages the A-S Login database. It facilitates the maintenance of user details and application set-up, and allows reviewing of the login history and audit trail.

The A-S Login validation software tool supports any database which has OLE-DB compatible drivers; including Access, Oracle and Microsoft SQL Server.

Administrator console features include:

• Maintains permitted applications, allowing versions and access rights to be controlled.
• Maintains the list of authorised users, including changing passwords, and disabling users when absent.
• Provides simultaneous login limits for users and applications.
• Attaches rights to users to allow them to use features within each application.
• Adds records to an audit trail recording every change made to the database by the administrator console.
• Allows the comprehensive login history and audit trail to be viewed and printed.
• Provides a centralised registry feature where applications can save their system wide settings.
• Maintains local settings such as minimum password length, length of password history and maximum password age in days.
• Provides a feature to read high priority events which may have been logged.

For further information contact us.