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Real Time Compliance Monitoring Software to Ensure Data Integrity

Real-Time Compliance Monitoring Software to Ensure Data Integrity

ComplianceBuilder™ is a real-time monitoring solution designed to enable 21 CFR Part 11 compliance to provide data integrity across IT systems such as file systems, database systems, laboratory or any manufacturing instruments.

ComplianceBuilder™ is a mature, proven and fully configurable real-time compliance monitoring software solution to provide 21 CFR Part 11 compliance across IT subsystems. By generating the audit trail and enabling electronic signatures, ComplianceBuilder™ allows you to securely track changes across all IT subsystems including file systems, databases, laboratory or manufacturing process equipment. It can be configured to monitor any file-based system for changes, including additions, deletions, and file modifications.

To enable data integrity, it enhances the security of the applications to a new level through a security wrapper that can be placed around the application and file storage area and by monitoring data changes, including data creation, deletion or modification. ComplianceBuilder™ offers complete flexibility in establishing your managed folder criteria by specific directory, workstation, file type, or file server.

Upon detecting a file change, ComplianceBuilder™ stores the file revision in a unique, secure data repository for ready retrieval of revision history. Compliance Builder provides complete flexibility to configure the system to monitor based on customer’s business rules to enable functionality such as managing eSignatures, user sign-offs or even setting up email alerts with no impact or interference to any application performance.

Additional security features, such as user access control, data security, full audit trail and a central data archive, enable the customer to prevent unauthorized use, including file/data deletion or modification. Offered in different license models based on customers need to manage compliance in one system or across multiple sites or enterprise.  Be it a file system (any file type including word, excel, or any data file type), or a database such as SQL Server, Oracle or MS Access or any instrument (Instron, UV-VIS, Special Microscope, Chemstation etc), ComplianceBuilder™  truly helps as one stop solution to remediate compliance challenges across the organization.

 

21 CFR PART 11 COMPLIANCE

FDA defines data integrity as a key component of the CFR Part 11 Compliance to ensure every electronic record has completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). ComplianceBuilder™ enables meeting the ALCOA requirements as highlighted below:

ALCOA Data Integrity Software

ALCOA Data Integrity Software

All of the elements of the acronym ALCOA are supported by ComplianceBuilder™ for ensuring data integrity.  Serving as evidence of the events that took place during any data collection activity which complies with regulations, thereby justifying that the data is safe and effective.

Additional features that promote Part 11 compliance include:

  • Comprehensive Application Security: A comprehensive application security layer integrates seamlessly into your existing security infrastructure, controlling both user administration and access to raw data. Layered security levels allow you to control access at both the application and file levels. Features such as sign-off authorization add additional layers of security, enabling full enterprise compliance.
  • Full Audit Trail: A detailed audit trail records changes made to file-based systems, databases, and laboratory equipment. For file-based systems, perform full retrieval and comparison of file revisions, including spreadsheets, Word documents, text files, and PDF files.
  • Configurable Electronic Signatures: For e-signatures, three levels of interaction are supported, including 1) Silent, 2) Acknowledgement and 3) Signature Confirmation.
  • Validation-Ready Platform: Xybion offers a comprehensive set of IQ/OQ documentation to support the implementation and validation. Further, Xybion can also support providing comprehensive services to specifically customize validation documentation to meet customer’s unique business requirements leveraging our Stelex Compliance Services practice.
  • Microsoft® SharePoint Monitoring and Fraud Detection. This is a new module of ComplianceBuilder™ which provides capabilities designed to monitor the SharePoint library and send the appropriate notifications if document downloads from the configured library exceed the specified time period. Upon fraud detection, an alert email is distributed to mitigate risk and allow for appropriate action from stakeholders.

Out-of-the-Box Functionality Includes:

  • Audit Trail
  • Electronic Signatures
  • Dashboards
  • Email Notifications
  • Database monitoring
  • Alerts
  • Version History
  • Controlled User Access
  • Spreadsheet Validation
  • Audit Schema Structure (DDL)
  • Multi-Platform Support, including Microsoft® SharePoint Server®, Microsoft®
  • SharePoint, Oracle Databases, and Microsoft® SQL Databases.

Benefits

ComplianceBuilder™ enables organizations to monitor and enable 21 CFR Part 11 compliance reducing enterprise regulatory risk. Features such as full audit trails and electronic signatures and maintaining revision history enable organizations to reduce or minimize compliance risks for critical file-based systems, databases, and laboratory equipment. Layered security features enable you to promote compliance with internal business practices and operating procedures, critical for companies operating in controlled GxP environments. As a flexible platform, ComplianceBuilder™ provides a best-in-class solution for monitoring business-critical information and systems, including:

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