What is Audit Trail Software?
Audit Trail Software automatically records who performed an action, what changed, when it happened, and why it occurred within a regulated computerized system. It creates a secure, tamper-evident history of every transaction, helping pharmaceutical manufacturers maintain complete traceability of electronic records.
Veritas GxP Audit Trail tracks activities across eBMR , Quality Management , Document Management, Electronic Signatures, CAPA, Change Control, Deviations, and Electronic Logbooks — supporting both US FDA 21 CFR Part 11 and India CDSCO requirements within a single, unified platform.
Why Pharmaceutical Manufacturers Need Audit Trail Software
Manual tracking and incomplete system logs make it difficult to investigate quality events, verify user activities, and demonstrate regulatory compliance during inspections. Missing or inaccurate activity records increase compliance risks and weaken data integrity.
Veritas GxP automatically records every regulated activity in a secure audit trail — helping organizations improve traceability, simplify investigations, and maintain complete accountability throughout the product lifecycle.
Common Audit Trail Challenges in Pharmaceutical Manufacturing
Powerful Features for Complete Activity Tracking and Traceability
Automatic Activity Logging
Capture every user action, modification, login, approval, and system event without manual work.
Time-Stamped Audit Records
Record the exact date and time of every activity for complete chronological traceability.
User Activity Tracking
Identify who created, reviewed, modified, approved, or deleted regulated electronic records.
Before & After Change History
View previous and updated values to see exactly what changed during every transaction.
Electronic Signature Traceability
Link electronic signatures with regulated records, approval reasons, timestamps, and authenticated users.
System Event Monitoring
Track logins, failed authentication attempts, permission changes, and administrative activities.
Advanced Search & Filters
Find audit records instantly using users, modules, dates, document numbers, or events.
Cross-Module Audit Trail
Maintain consistent audit history across eBMR, DMS, QMS, CAPA, and Change Control.
Audit Reports
Generate inspection-ready reports for regulatory audits, internal reviews, and compliance checks.
Secure Data Protection
Maintain tamper-evident audit records that preserve the integrity of regulated data.
Regulatory & Compliance Support
Support audit trail controls aligned with applicable GMP, 21 CFR Part 11, EU GMP Annex 11, and CDSCO requirements.
Audit Record Filtering & Export
Filter audit records by user, activity, date, module, document, or transaction and export relevant history for investigations, reviews, and inspections.
Simple Workflow for Complete Audit Trail Management
User Activity Capture
Capture every regulated action performed within the Veritas GxP platform.
System Validation
Verify that every activity meets configured business and compliance rules.
User Identity Capture
Record the authenticated user responsible for each transaction.
Record Date & Time
Automatically generate secure timestamps for every activity.
Track Before & After Changes
Maintain complete visibility of previous and updated record values.
Link Electronic Signatures
Associate approvals with authenticated electronic signatures when required.
Store Audit Record
Securely preserve audit information throughout the electronic record lifecycle.
Generate Reports
Produce complete audit history for inspections, reviews, and investigations.
Key Benefits of Complete Audit Trail Management
Complete Traceability
Track regulated activities from record creation through modification, review, approval, and completion.
Data Integrity
Maintain secure, time-stamped activity history that supports the integrity and traceability of electronic records.
Faster Investigations
Quickly identify users, actions, timestamps, and before-and-after changes when investigating quality or compliance events.
Simplified Compliance
Access searchable audit history and inspection-ready reports without manually collecting records from multiple systems.
Better Inspection Readiness
Associate regulated actions with authenticated users to provide clear responsibility for system activities.
Increased Accountability
Associate regulated actions with authenticated users to provide clear responsibility for system activities.
Centralized Visibility
Monitor audit activity across connected Veritas GxP modules through a unified traceability layer.
Reduced Manual Audit Preparation
Simplify audit reviews by providing centralized, searchable activity history and reporting.
Improved Operational Transparency
Provide complete visibility into regulated business processes in real time.
Enterprise-Wide Standardization
Apply consistent audit trail practices across all manufacturing sites.
Rapid Deployment
Configure and deploy audit trail capabilities within the Veritas GxP platform without relying on separate legacy logging systems.
Built to Support Global Pharmaceutical Compliance
GMP
Track regulated manufacturing activities with complete traceability.
21 CFR Part 11
Support secure, computer-generated, time-stamped audit trails for US operations.
India CDSCO
Designed to support applicable India CDSCO requirements for electronic records and audit trail controls.
EU GMP Annex 11
Supports audit trail and computerized-system controls aligned with applicable EU GMP Annex 11 requirements.
ALCOA+
Protect attributable, accurate, and enduring electronic records.
Electronic Records
Maintain complete history throughout the record lifecycle.
Electronic Signatures
Link approvals with authenticated electronic signatures.
Data Integrity
Protect regulated information from unauthorized modifications.
Why Pharmaceutical Manufacturers Choose Veritas GxP Audit Trail
Veritas GxP is purpose-built Audit Trail Software for pharmaceutical manufacturers who need tamper-evident, fully traceable records under both US and Indian law, without the deployment delays of legacy logging platforms.
Veritas GxP Audit Trail provides a centralized traceability layer for regulated pharmaceutical operations. It automatically records user activities, system events, record changes, approvals, and applicable electronic signatures across connected GxP workflows.
Because audit trail capabilities are integrated across the Veritas GxP platform, organizations can maintain consistent activity history across eBMR, Quality Management, Document Management, CAPA, Deviations, Change Control, and Electronic Logbooks.
Advanced search, before-and-after change history, secure audit records, and inspection-ready reporting help quality and compliance teams investigate events efficiently and demonstrate traceability during internal reviews and regulatory inspections.
Need Help? Start Here...
Get Started Free Call?
+91 9260246321Audit Trail Software automatically records every regulated activity, user action, and system event to maintain complete traceability of electronic records.
It provides complete visibility into regulated activities, supports investigations, protects data integrity, and demonstrates compliance during regulatory inspections.
The system records user identity, activity performed, timestamps, before-and-after changes, approvals, electronic signatures, and system events.
Yes. Audit records are securely maintained to preserve the integrity and authenticity of regulated electronic records.
Yes. The platform maintains secure, computer-generated, time-stamped audit trails supporting regulated electronic records and signatures.
Audit trails are available across eBMR, QMS, DMS, CAPA, Deviations, Change Control, Electronic Logbooks, and other Veritas GxP applications.
Yes. Inspection-ready reports can be generated instantly for internal reviews and regulatory audits.
An audit trail should record relevant information such as the user responsible for the activity, the action performed, date and time, applicable record or transaction, and where applicable the previous and updated values.
A before-and-after audit trail records the value or state of a regulated record before and after a change, helping reviewers determine exactly what was modified.
An audit trail provides traceability for changes to electronic records, helping organizations understand who performed an action, what changed, and when the activity occurred.
Yes. Searchable user activity, timestamps, system events, and before-and-after changes can help quality teams investigate deviations, data discrepancies, and other regulated events.
Yes. Searchable and reportable audit history can help organizations demonstrate traceability of regulated electronic records during internal reviews and regulatory inspections.
Yes. Audit records can be searched and filtered using criteria such as users, dates, modules, document numbers, activities, and events.