Overview

Auditca™ is an audit report generation tool for auditors in regulated environments. Auditca™ is a 21 CFR Part 11 compliant system and a web-based application developed with ex-FDA auditors and other compliance experts to facilitate an Auditor or an Inspector in compiling his or her inspection report. Auditca™ combines a collaborative environment for the redacting of inspection report information including, but not limited to, observations, exemplars, discussions, notes and references, with an updated regulatory library of FDA and international regulations along with the ability to include a “user-specific” observation library.

Why every auditor deserves Auditca™?

Auditca™ streamlines the audit reporting process ultimately making the auditor’s work easier. PSC has developed an innovative application with regulatory references and collaboration in mind in an easy-to-use interface.

Key Benefits:

• Built-in references and regulatory libraries at the auditors fingertips
• Consistent and controlled audits
• Accelerates report completion
• Increases collaboration
• Maximization of auditor’s efficiency.
• Platform for executing detailed, targeted and consistent audit reports.

Main Features:

• Extensive library of the current regulations of various regulatory bodies for US, Canada, China, EU/EC, Japan, UK and other international regulations with search and reference capabilities.
• Observation Library with configurable observation templates.
• Multiple versions including final report.
• Tracking of findings (via optional module) by replacing Outlook, cGMP or desktop tools with an integrated tracking & reporting module.
• Archival of all audit history.
• Configurable to fit your auditing needs.