Ensure Data Integrity and 21 CFR Part 11 Compliance
The FDA requires that all data submitted to the administration is reliable and accurate. Compliance Builder supports all elements of the acronym ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) to ensure data integrity.
Data has always been important to life sciences companies involved in pharmaceutical manufacturing and research. The importance of data integrity is growing exponentially as regulatory requirements evolve. With Compliance Builder, you can safeguard your data and prove that it has not been compromised.
Compliance Builder lets you automatically conform to the principles of ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate).
Additional features of Compliance Builder that promote CFR Part 11 compliance include:
Compliance Builder includes built-in modules for monitoring files, databases, and SharePoint sites. Our database monitoring module allows you to manage and control any RDBMS-based system, including SQL-based applications, batch systems, and custom-developed database applications.
Our real-time database module facilitates monitoring all files Subject to 21 CFR part 11 regulations.
For each database table, Compliance Builder:
With Compliance Builder, you get customizable reports that allow you to manage your business. Reports display data from monitored RDBMS records in both summary and detailed formats. You can optionally configure reports to display only selected database tables or fields, or simply the old/new values of the data that was changed.
Compliance Builder includes built-in modules for monitoring files, databases, and SharePoint sites. Our out-of-the-box file monitoring module facilitates monitoring files subject to 21 CFR Part 11 regulations.
With the Compliance Builder File Compliance module, you can:
Compliance Builder gives you the ability to manage sensitive company data and protect your most valuable data assets. When we say any file type, we mean it!
Compliance Builder is designed to monitor any type of file.
“Being able to track the lifecycle of desired files has repeatedly enabled my team to quickly resolve discrepancies saving valuable time in file forensics work and documentation.”
– Client Feedback
If your organization relies on Microsoft SharePoint for enterprise storage of critical business data and associated files, Compliance Builder can help you achieve CFR Part 11 compliance and reduce operational risks by enabling the detection of abnormal activities.
With the Compliance Builder SharePoint module, you can:
Gather information stored in SharePoint and report on download activity for highly sensitive files.
Act on information quickly and prevent the misuse of critical information in SharePoint with real-time email alerts.
Prevent SharePoint users from exceeding the maximum number of downloads and monitor unusual activities via automated reporting features.
Compliance Builder enables you to monitor and audit SharePoint libraries. The SharePoint server configuration page enables you to configure the system to gather information regarding download activity and receive email alerts when threshold limits are exceeded.
Compliance Builder supports SharePoint versions 2007 and above and does not require installation on the SharePoint server. The software is seamlessly integrated with your routine IT ecosystem.
Xybion Corporation’s upgraded Compliance Builder v11.0 enhances and facilitates real-time compliance monitoring services with improved access control, audit trail, file security, and multi-language support features (including Mandarin), thus enabling global life science organizations to leverage new business opportunities.
The new version helps to prevent any data loss due to accidental/intentional file deletion by users when directories are being monitored through the File Deletion Control feature. Further, this functionality is supported by modified Access Control which allows only designated applications and authorized users access to critical digital data.
In addition to the e-signature facilities the new version shall provide a means for Review and Approval of all actions performed by instrument operators. All reports have been updated to generate in PDF format as well, all of which can be digitally signed and maintained by the system further eliminating the need for paper records.
Application security has been enhanced to ensure only properly trained operators may utilize instrument software secured by Compliance Builder. Any unauthorized attempts to access a workstation or secured application will be recorded.
The additional features of CB v11.0 enable organizations to enhance the monitoring and tracking of 21 CFR Part 11 compliance, reducing enterprise regulatory risk.