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.
ALCOA Data Integrity Software
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 allows you to control access at both the application and file levels. Features such as sign-off authorization add additional layers of security enable 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 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 implementation and validation. Leveraging our Stelex Compliance Services practice, Xybion can also provide comprehensive services to specifically customize validation documentation to meet customer’s unique business requirements.
- 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 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
- Compare Feature added to File Audit Trail Report
- Electronic Signatures
- Email Notifications
- Database Monitoring
- Version History
- Controlled User Access
- Disable Function at User and Domain level
- Screen Lock is implemented as part of CBAgent
- Spreadsheet Validation
- Audit Schema Structure (DDL)
- Microsoft Access Integration
- System Clock Change Notification
- Multi-Platform Support, including Microsoft SharePoint Server, Microsoft SharePoint, Oracle Databases, and Microsoft SQL Databases
ComplianceBuilder enables organizations to monitor and enable 21 CFR Part 11 compliance to reduce enterprise regulatory risk. Features such as full audit trails, electronic signatures and revision history reduce or minimize compliance risks for critical file-based systems, databases, and laboratory equipment. Layered security features promote compliance with internal business practices and operating procedures which are 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