Organizations operating in regulated, life science environments face constant pressure to maintain data integrity, ensure system security, and meet evolving regulatory expectations such as FDA 21 CFR Part 11. By providing real-time compliance monitoring, electronic signature control, and computer-generated audit trail functionality, Instem’s Compliance Builder has been a trusted solution for this purpose.
Now, Instem has enhanced this platform further with the release of Compliance Builder version 12. Compliance Builder 12 delivers an array of new features designed to make compliance management more secure, more flexible, and more efficient than ever before. This article explores the new features offered by this platform and how they act to enhance compliance strategies.
Features of Compliance Builder 12
Compliance Builder 12 offers new capabilities that directly address customer needs. These updates include strengthened security, improved system usability, and expanded automation options.
Folder Monitoring Alerts
Administrators can now create custom alerts for individually monitored folders based on predefined thresholds for file creations, modifications, or deletions. This allows users to detect unusual or potentially unauthorized changes in real time, reducing risk before small issues escalate into major compliance incidents. For quality and IT teams responsible for protecting sensitive research and data, this capability offers a powerful new layer of operational oversight.
Support for Temporary Users
Data protection requirements are becoming increasingly stringent. Compliance Builder 12 responds to these developments with multiple upgrades targeted at security. The platform supports temporary user accounts, enabling administrators to assign access to contractors or short-term staff that automatically expires after a set period of time. Regular user accounts can be configured to expire following inactivity, allowing organizations to maintain tighter restrictions over system access.
Improved Application Security
Protecting sensitive data now requires greater levels of control. This is why Compliance Builder 12 has been updated with an enhanced Secure Application feature. Now, access can be limited to designated Compliance Builder user groups. This ensures secure files are not changed by those without approval.
There are also a number of other security and performance improvements that help organizations align better with modern cybersecurity standards. These include:
- Stricter password conditions and passwords up to 50 characters for internal user accounts
- Database query performance tuning and updates
- Improved connection stability
These enhancements help to ensure that monitoring and security functions operate stringently and smoothly, without affecting performance on the applications being monitored.
Automated Reporting
Compliance reporting is essential, yet can also be time-consuming. Compliance Builder 12 introduces automated reporting, allowing users to schedule any existing report to run automatically at defined intervals. Reports can be filtered according to specific criteria and delivered directly to dashboards or distributed by email, eliminating repetitive manual effort.
Full Validation for Windows and Multiple Windows Sessions
Seamless integration of this platform across existing systems allows both ease of use and ease of access. Compliance Builder 12 is fully validated for Windows 11 and Windows 2022. Multiple users may also be logged in to a device at one time and maintain a stable connection to the Compliance Builder platform, supporting a more efficient and smooth user experience.
Conclusion: An Enhanced Platform for Total Compliance
Instem remains focused on enabling organizations to meet 21 CFR Part 11 requirements with this new version of Compliance Builder, but does so with a number of new features that facilitate seamless and secure management of files.
Folder monitoring alters, strengthened security and access controls, and more intelligent monitoring result in a solution that not only helps to maintain compliance but also improves day-to-day operations.
For organizations seeking a cost-effective way to safeguard data integrity across files, databases, and applications, Compliance Builder 12 represents a significant step forward. Contact us today to see how these powerful new features could help strengthen your compliance strategy.
