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 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.
21 CFR Part 11 compliant user login functions
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 checksumming techniques to protect data from accidental or deliberate falsification.
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.
The 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.
A-S Login supports any database which has OLE-DB compatible drivers; including Access, Oracle and Microsoft SQL Server.
Administrator console features include: