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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

Attributable – Is it traceable to a person, date, and time?

ComplianceBuilder™ enables tracking all events (data creation/deletion/modification) and enables electronic signatures as well. Data is attributable to a unique user with a secure password and role-based permissions, preventing changes from being made by unauthorized users.

Legible – Is it clear enough to read?

ComplianceBuilder™ eliminates the need for any paper record as the Electronic source records from the system are captured in a clean and standardized format.

Contemporaneous- Was it recorded as it happened?

ComplianceBuilder™ monitors data in real time and records the data at the time it is created.  Automatic date and time stamps support this every time data is entered, edited, or modified in the system that has the appropriate controls in place to fully support compliance with 21 CFR Part 11.

Original – Is it the first place data is recorded?

ComplianceBuilder™ being a real-time monitoring solution enables securing the data the first time when it is created.  Compliance Builder automatically keeps a record of all the revision history whenever any change or deletion happens.

 Accurate – Are all the details correct?

ComplianceBuilder™ enables the traceability of the data from the time it is created thereby ensuring accuracy.

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:

  • Files On Your Workstations Or File Servers
  • Tables In Your Databases
  • Process And Manufacturing Equipment

Compliance Builder version 9.2

Xybion has released a new version upgrade (v9.2) of ComplianceBuilder™. This new release enhances the compliance coverage and supports new software and latest versions to support 21 CFR Part 11 compliance. This release adds compatibility with multiple platforms of different servers and browsers. It also supports multiple domains and screen-locking feature as a part of CB Agent on the workstations.

One of the main benefits of Compliance Builder v9.2 is the ability to compare selected revisions with previous file versions of MS Word, MS Excel and Notepad documents for enhanced reporting in the File Audit Trail Report. Additional compatibility and functionality have been provided for efficient monitoring within Oracle, MS SQL Server, MS Access and Windows 1O environments. These additional features enable organizations to monitor and track compliance with 21 CFR Part 11 dynamically, reducing enterprise regulatory risk.

Some of the exciting New key Features in Compliance Builder® 9.2.0

  • Support for Multiple domains in the Network
    • Now users from multiple domains across your network can automatically be imported and can connect to Compliance Builder® with the same Windows credentials they are accustomed to using on a day to day basis.
  • Screen Lock is implemented as part of CBAgent
    • Each workstation monitored by Compliance Builder® can be configured to lock automatically after a configurable amount of time to allow lengthy processes to continue to run without interruption and no security risk of leaving a workstation unattended.
  • Disable function at User and Domain level
    • Users can be easily disabled or an entire domain of users can be easily disabled at the press of a button.
  • Compare feature added to File Audit Trail Report
    • Differences between versions of files can now quickly be accessed right from the File Audit Trail Report. Clicking the new Compare button will immediately perform the comparison of the latest version to the previous version and display the results in a new tab.
  • Microsoft Access integration
    • Receive real-time notification of changes to fields within an Access database. Just like with MS SQL and Oracle database monitoring, Compliance Builder® can be configured to monitor just for specific tables and fields of an MS Access database.
  • System Clock Change Notification
    • Any changes to the Windows system date/time can be automatically audited by Compliance Builder®.
  • Compliance Builder® version 9.2 has been enhanced and fully validated with the latest technology:
    • Oracle 12c
    • MS SQL Server 2012
    • MS SQL Server 2014
    • Windows 10
    • Windows server 2012R
    • Google Chrome
    • MS Access 2016
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