For pharmaceutical companies operating in controlled GxP environments, making sure that all systems remain in 21 CFR Part 11 compliance is not just important – it’s imperative. With Compliance Builder, you can seamlessly manage electronic document and signature control compliance across all IT sub-systems.
With comprehensive security features, such as user access control, data security, audit trails, and a central data archive, companies can prevent unauthorized use, including file/data deletion or modification.
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.
By generating an audit trail and enabling electronic signatures, Compliance Builder serves as an audit management system that allows you to securely track changes across all IT subsystems including:
Upon detecting a file change, Compliance Builder stores the file revision in a unique, secure data repository for ready retrieval of revision history.
Compliance Builder brings application security to a new level through a security wrapper that is placed around the application and file storage area. The software offers complete flexibility in establishing managed folder criteria by:
Compliance Builder is offered in different license models. We’ll help you select the version that works best based on whether you need to manage compliance in one system, across multiple sites, or an entire enterprise — whether it is on a file system (any file type including Word, Excel, or any data file), a database such as SQL Server, Oracle or MS Access, or any instrument (Instron, UV-VIS, Special Microscope, Chemstation, and more).
Xybion Corporation’s upgraded Compliance Builder v10.0 enhances and facilitates real-time compliance monitoring services with improved access control, audit trail, and multi-language support features (including Mandarin), thus enabling global life science organizations to leverage new business opportunities.
The new version prevents 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 a designated and authorized user to close the events with enhanced e-signature facilities.
An audit report with session duration information is automatically generated by login/log-out activity when the screen lock function is used. This allows the user to perform reconciliation of an event signoff timeout.
The additional features of CB v10.0 enable organizations to enhance the monitoring and tracking of 21 CFR Part 11 compliance, reducing enterprise regulatory risk.
Multi-lingual functionality is one of the best new features of CB 10.0. A simplified Chinese language pack is included, and other language packs can be added on demand.
Prevent files from being accidentally or intentionally deleted by users while accessing the directories through a Secure Application feature.
Generate an audit report based on specific data events, such as data creation, deletion, or modification, and with login/log-out session with duration information.
Configure the meaning of e-signatures for data events through Picklist. This can be monitored through an audit trail to prevent super users (like Admin) from changing the choice of Picklist later.
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 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.
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 is designed to monitor any type of file. Commonly monitored file types include:
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.
105 College Road East
Princeton, New Jersey 08540
105 College Road East
Princeton, New Jersey 08540
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.
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