Audit Trail Automation: How PERFEQTA Enhances Efficiency and Accuracy

ISO 15189

Maintaining detailed, accurate audit trails is a critical component of any quality management system.

But manually tracking and documenting audit trails can be extremely tedious and inefficient.

Fortunately, advanced quality management software like PERFEQTA allows organizations to automate audit trail processes, enhancing both productivity and data integrity.

What Is An Audit Trail?

An audit trail provides documented evidence of the sequence of activities that have affected a specific operation, procedure, or event.

In quality management, audit trails demonstrate due diligence and regulatory compliance by providing a detailed account of actions, changes, and results.

Robust audit trails facilitate internal audits and external inspections by regulatory agencies.

Manual Audit Trail Management

Without automation, audit trail management involves manual processes like:

  • Recording details of activities, such as date, time, and personnel involved
  • Tracking changes to documents, data, or records
  • Maintaining accurate version histories of documents and records
  • Ensuring that changes are made only by authorized personnel
  • Retrieving and presenting audit trail data for audits or inspections

This manual approach requires meticulous effort and consumes enormous amounts of time and resources. Even then, it remains vulnerable to human error and inaccuracies.

Automated Audit Trails with PERFEQTA

PERFEQTA delivers automated audit trail tools to optimize this critical quality process. Key features include:

  • Automated data collection – PERFEQTA automatically captures details like user ID, date/time stamps, data values, and record changes.
  • Tamper-proof records – Audit trail records are generated in read-only format to prevent alterations.
  • Customizable tracking – Users can define specific actions or events to be tracked for granular audit trails.
  • Centralized access – Audit logs are maintained in a centralized location for quick retrieval.
  • Automated reporting – Audit data can be extracted into reports or presented for audits with just a few clicks.
  • Comprehensive search – Robust search capabilities allow specific items or audit events to be quickly located.

Benefits of Automated Audit Trails

Automating audit trail processes with PERFEQTA transforms efficiency, accuracy, and transparency:

Improved Productivity

  • Eliminates time-consuming manual documentation of audit logs
  • Frees up personnel to focus on value-added tasks

Enhanced Accuracy

  • Minimizes risk of human error in documenting trails
  • Provides precise system-generated activity records
  • Maintains flawless version histories of controlled records

Strengthened Compliance

  • Meets requirements for detailed audit trails
  • Provides thorough evidence of due diligence for audits
  • Supports conformity to regulations like FDA 21 CFR Part 11

Increased Visibility

  • Allows audit trails to be reviewed in real time
  • Enables customized reports and views of audit data
  • Supports proactive quality issue identification

The automated audit trail functionality delivered by PERFEQTA represents a fundamental improvement over traditional manual approaches.

Companies can leverage these tools to boost productivity, ensure compliance, and make the critical process of audit trail management faster, simpler, and more reliable.

For organizations seeking to optimize quality management, PERFEQTA provides transformative technologies to automate workflows, ensure standards conformance, and gain data-driven insights.

A centralized platform with enterprise-class capabilities, PERFEQTA enables businesses to build, manage, and continuously improve upon world-class quality systems with unprecedented efficiency.

Frequently Asked Questions

A: PERFEQTA can track additions, edits, deletions, or views of any record or data field. This includes changes to documents, training records, CAPAs, alerts, suppliers, products, specifications, and more. 

A: Yes, PERFEQTA delivers automated audit trails that meet Part 11 and other regulatory requirements including EU Annex 11, ISO 9001, ISO 13485, AS9100, and more. 

A: Audit logs are generated as read-only records that cannot be edited or deleted. This ensures the integrity and accuracy of the data. 

A: Audit logs can be easily exported into common formats like PDF or CSV for audits, analysis, or long-term archival. 

A: Robust analysis and reporting of audit data within PERFEQTA enables organizations to identify potential problems or non-conformances before they occur. 

A: User access to audit logs can be precisely restricted. Data can even be anonymized to protect confidentiality. 

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