Auditca™ is a web-based application developed with ex-FDA auditors and other compliance experts to facilitate an Auditor or 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.

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.

Benefits:

• Helps auditors conduct audits in a consistent and controlled manner
• Designed and built based on the influential input of past FDA inspectors as well as respected regulatory auditors, and their recommendations for an audit report management applications
• Provides a means of executing detailed, targeted and consistent audit reports
• Embedded key regulatory information is at the auditors fingertips
• Efficiency
  • All the tools at hand
  • Uniform way of working
  • Team collaboration
  • Easy to use
• Control
  • Predefined language and terminology
  • Defined access
• Standardization
  • Standard language
  • Standard audit scoring
  • Standard look and feel of reports

Key Features:

Regulatory Library

• Extensive library of the current regulations of various regulatory bodies for US, Canada, China EU/EC, Japan, UK and other international regulations
• Upload company-specific regulations to a Company library to have as a reference

Observation Library

• Customizable Observation library from which template observations can be extracted for use in subsequent reports
• Company specific wording and nomenclature can be preserved

Extensive Search

• Keyword search through regulations and observations
• Use search results directly in the reports

Interactive Reporting

• Reference directly from the regulatory and company libraries to the audit observations and reports

Customized Reports

• Customizable audit report templates

Web-based

• No local installation required
• Access through any desktop web browser

Team Enabled

• Permits auditors to work on the same audit report simultaneously

Controlled Access

• Editing and sign-off abilities process the report through signature channels

Intuitive Design

• Allows audit environments to be quickly set-up