Does Zetron’s system support data integrity and audit trail functionality?

Our system is engineered to ensure complete data integrity and comprehensive audit trail capabilities, meeting the most stringent regulatory requirements for electronic records management.

• Full 21 CFR Part 11 Compliance: Our system fully complies with US FDA 21 CFR Part 11 requirements for electronic records and electronic signatures. This ensures that all data entries, modifications, and approvals are both legally binding and regulatory compliant.
• Comprehensive Audit Trail: Every system operation is automatically logged with user identification, timestamps, and action details. The secure audit trail captures creation, modification, and deletion events, providing complete visibility into data lifecycle activities.
• Data Integrity Safeguards: Advanced security controls prevent unauthorized data alteration or deletion. All records are protected by electronic signatures, checksum verification, and secure user authentication protocols.
• Regulatory Inspection Ready: Built-in reporting tools enable rapid generation of audit trails for regulatory inspections. Data remains accessible, legible, and retrievable throughout the required retention period.

This design ensures full traceability, protects data from unauthorized modification, and helps your facility maintain compliance, data integrity, and operational transparency at all times.