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Home > Products > Part 11 Toolkit
Part 11 Toolkit
Part 11 Toolkit makes your existing Access databases 21 CFR Part 11 compliant. In one day, features are added to your Access program to track changes, control access and prevent unauthorized changes through password protection, audit trails, and electronic signatures.
Security

- Unique Login ID's and Passwords are assigned to all users and required for all logins. All programs password protected.
- Password Requirements for complexity and expirations can be set by Administrators.
- Multiple Levels of Security allows for different parts of your program to be seen or updated by users with the appropriate credentials.
- Meets requirements in 21 CFR Part 11.10.d, 11.10.g, etc. for limiting system access, password control and authority checks.
- Provides interface to use LDAP/Active Security for user authentication.
- View screen shots of the password entry and requirements forms.
User Administration

- Administrators can add and remove users from security groups.
- Allows administrators to add and remove users from the program.
- Allows administrators to reset passwords.
- Meets requirements in 21 CFR Part 11.10.d for limiting system access to authorized users.
- View screen shots of the user management forms.
Audit Trails

- Audit Trails provide a complete change history for each record.
- Event Logs record any event that occurs within the program, including logins, logouts, error messages, or any other event specified by the program.
- Meets requirements in 21 CFR Part 11.10.e for audit trails.
- View a screen shot of the audit trail screen.
Electronic Signatures

- Add Electronic Signatures to any form within your program.
- Records are Locked from being updated once signed.
- Developers may implement advanced features, such as batch signing of records.
- Meets requirements in 21 CFR Part 11.50 and 11.200.a for electronic signatures.
- View screen shots of the electronic signature form and example usage.
Search Engine with Customizable Results

- A Search Engine is included that allows users the ability to search for any records contained within your program. The Search Engine is completely secure and includes the ability to view search results in any number of customized reports.
- View screen shots of the search engine form and sample usage.
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