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The Blanketed Audit Process...

NOTE: This is only an example of a Audit Process.

Audit Summary Scope

Audits will include, but not be limited to, the tasks described below.

The auditor shall conduct audits according to the applicable governmental authority (e.g., FDA (CDER, CBER, CDRH, CVM and/or CFSAN), EMeA, ICH, ISO, etc.), current Good x Practices, and all applicable local requirements, predicate rules and all applicable Standard Operating Procedures.  

CVs will be presented as required.

Auditor’s Requirements:

  • Auditor will schedule audit dates directly with the Auditee and Client, and will send out a confirmation letter (copies to Client’s staff).
  • If Audits are scheduled by a 3rd party or host Sponsor, then the Company's standards will be utilized.
  • Travel Arrangements - Auditor will arrange their own travel arrangements and following the client’s travel policies.  Arrangements will include airfare, hotel, and ground transportation.

Pre-audit activities will include, but not limited to:

  • Review of applicable Protocols, organizational charts, Table of Contents for formal written SOPS when available.
  • The creation and submission of the Audit Confirmation Letter, and/or Audit Agenda/Audit Plan to be sent to Client and Auditee prior to audit
  • A review of all audit preparation materials prior to the audit implementation.

Audit activities may include based on requirement, but not be limited to:

    • Assessing the scope of work of the Auditee (Sponsor/Client and/or Vendor/Supplier) and comparing it to the contracts and documentation supplied to the Client,
    • Understanding and ensuring that the responsibilities of each Auditee are documented and well understood by the auditor.
    • Onsite Activities and Review of (based on applicability):
      • Interviews with key staff
      • Organizational charts
      • Interview and selective personnel and key staff
      • CV/Job descriptions roles and responsibilities review
      • Training records
      • Training programs
      • Quality Assurance Program and Procedures
      • Quality Control Process, Testing and Procedures
      • Vendor/Supplier Qualification/Inspections/Audits
      • Standard Operating Procedures, Work Instructions, Policies and Practices
      • Document Control
      • Regulatory Affairs and Inspection History
      • CRFs and Patient Diary Documentation and Systems (For Clinical Audits)
      • Study data and databases (For Clinical Audits)
      • Computerized Systems in support of GxP activities, 21 CFR Part 11 and Submissions
      • Pharmacy and drug reconciliations (For Clinical Audits)
      • Monitor activities (For Clinical Audits)
      • Data management activities (For Clinical Audits)
      • Network Infrastructure and Systems Management/Security Procedures
      • Facilities including physical inspections
      • Engineering, Maintenance, Metrology, Janitorial and Facilities
      • Test facility operations
      • Study Director selection/qualification/training (For Clinical Audits)
      • Corrective and Preventative action programs (CAPA, Facilities and Systems)
      • Preparation and Tracking of Standards
      • Methods Development/Transfer/Validation
      • Quality Control/Blank Checks
      • Evaluation of Standard Curves
      • Accuracy and Precision of Data
      • Change/Process Control
      • Tracking Analytical Results and Compliance (GLP Audits)
      • Acceptance and Rejection Criteria
      • Retest/Repeat Analysis
      • Test and Control Article Chain of Custody (GLP/Clinical)
      • Equipment/Instrumentation; Qualification/Validation/Calibration/Maintenance
      • Water System, Waste Systems and Facility Utility Qualification/Validation
      • Computer validation, including 21 CFR Part 11 Compliance
      • Environmental Systems/Monitoring
      • Specimen/Sample/Collection Receipt/Identification/Handling/Documentation (GLP/GCP)
      • Data collection/verification/management (GLP/GMP and GCP)
      • Report preparation/review/approval/revision
      • Archival system
      • Record retention program
      • Deviation reports/QA reports, CAPA

The Auditor may issue an audit certificate after successful completion of the audit and finalization of the audit if required.


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