Part 11 Toolkit Details

The Part 11 Toolkit provides security and compliance features for MS Access databases, including password protection, audit trails, and electronic signatures.

Security

• All programs are password protected. Unique login IDs and passwords are assigned to all users and required for all logins.
• Customizable Password Requirements for complexity and expirations can be set by administrators.
• Multiple Levels of Security allow for different parts of your program to be seen or updated by users with 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

User Administration

• Administrators have full control over users.
• Administrators can add and remove users from security groups.
• Administrators can and remove users from the program.
• Administrators can define password requirements.
• Meets requirements in 21 CFR Part 11.10(d) for limiting system access to authorized users.

Audit Trails

• Audit Trails provide a complete change history for each record.
• Event Logs record all critical system events that occur within the program, including logins, log-outs, error messages, or any other event specified by the program.
• Meets requirements in 21 CFR Part 11.10(e) for audit trails.

Electronic Signatures

• Add Electronic Signatures to any form within your program.
• Records are locked and cannot be updated with an applied electronic signature. Removing the electronic signature allows the record to be edited. Adding or removing an electronic signature is automatically recorded on the audit trail.
• 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.

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.