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The Audit Report...

Note: This is an example of an audit report template format

Note: The Audit may require utilizaiton of the Client's report formats. As long as there is adequate training for completion of the report, then there would be limited risk.

In addition, the Audit may require the use of Audit Management Software, i..e TrackWise, MasterControl and others. Again, as long as there is adequate training, then there would be limited risk.

Audit Report Format

Audit reports are completed in draft form and available 7 – 10 business days from last day of audit. 

A complementary executive summary of audit findings may be available within 72 hours based on time allowances and upon written request from the client.

All audit reports are printed and coil bound as hard copy documents.  Electronic reports will be available at the Client’s requests.

I have the capability of working within the scope of your firm’s audit requirements and audit report formats, however all Auditor generated audit report formats will be first approved by Client and in most cases will include, but limited to:

1.0 Introduction and General Auditee Information
1.1 – Background
1.2 – Scope
1.3 – Objective
1.4 – Risk Assessment Statement (Classifications) Statement
1.5 – Facility Description – Logistics Statement
1.6 – Quality Assurance Practices and Initiatives Overview Statement
1.7 – Quality Control Practices Overview Statement
1.8 – Maintenance and Calibration Practices
1.9 – Personnel Information and Personnel Interviewed / CVs audited
1.10 – Deliverables Reviewed (SOPs, Manuals, Validation Documents, DMFs, DHFs, etc…)
1.11 – Personnel, Materials and Process overview – Flow diagrams Overview Statement
1.12 – Equipment/Process Systems Overview Statement
1.13 – Hardware / Software Overview Statement
1.14 – Receiving, Storage and Distribution Overview Statement
2.0 Executive Summary
3.0 Observations (table format – see example below.  NOTE: Not all chapters may apply.  Based on applicability and scope of audit)
3.1 – Corporate
3.2 – Quality Assurance (including but not limited to)
            Standard Operating Procedures, Work Instructions, Internal Procedures
            Policies, Manuals and Practices
            Training and Roles and Responsibilities
3.3 – Quality Control
3.4 – Clinical (if applicable)
3.5 – Regulatory Affairs (if applicable)
3.6 – Manufacturing / Pilot Plant (if applicable)
3.7 – Warehouse, Storage, Material Handling and Purchasing (if applicable)
3.8 – Human Resources – Employee Management (if applicable)
3.9 – Research and Development (if applicable)
3.10 – Facilities (Engineering, Maintenance, Calibration and Support Services)
3.11 – IT, IS, MIS, Information Management, Computer Systems
3.12 – 21 CFR Part 11
3.13 – Analytical and Testing (if applicable)
3.14 – Validation and Qualification
3.15 – 3rd Party Qualifications (i.e. Contract Manufactures, Analytical Services, Packaging Services, ISP/ASPs, Warehouses, Depots, CROs, etc…)
4.0 Conclusions
5.0 Reference Standards
6.0 Audit Plan / Audit Agenda
7.0 Audit Check List (attached applicable check lists)
8.0 Audit Revision History (for follow up use)
9.0 Audit Remediation Plan - Attach follow-up remediation plan and Gantt charts (for follow up use)
10.0 Audit Follow-up Review Plan (for follow up use)

 

TAG standard Audit Reports

Section 3 – Audit observation findings - Constructed in table format, with one finding per page, separated by department and/or role/responsibility.

TAG standard table format consists of:

  1. Findings – in outline format, includes:
  • Observation Nr: i.e. 3.1, 3.2, 3.3 etc.
  • Observation Title: A short descriptive title of the observation – No longer than 126 characters, i.e. Quality Assurance, Manufacturing, Facility, etc…
  • Gantt Line Item/Nr: If item is reference a TAG Gantt Chart (Optional)
  • CAPA Nr: If item is referenced by a CAPA system (Optional)
  • Observation description: itemized by a alpha character, i.e. a) b) c).  Unless specified otherwise by client or client’s SOP.
  • Risk Assessment Statement:  {Short risk statement}  Observations are rated according to the following severity list/definitions:
    • Significant Observation:  An observation that is highly likely to result in an EMEA and or FDA 483 observation and Warning Letter, and seriously jeopardize safety and/or quality of a study and a BLA/NDA. 
    • Major Observation:  An observation that could result in an EMEA and or FDA 483 observation and has an impact on safety and/or quality.  Collectively, a large number of major observations could result in a Warning Letter and jeopardize a BLA/NDA.
    • Minor Observation:  An observation that is not likely to result in an EMEA and or FDA 483 observation and has minimal impact on quality/safety; however, collectively a large number of minor observations would make a negative impression during a health authority inspection.
  • Suggestion for Remediation / Deviation:  {Filled out by Auditor to include suggestions}
  • Client’s Response – Resolution/Remediation:  {Filled out by Auditee}
    • Auditee Commitment
      •  Commitment By:
      •  Responsibility Department:
      •  Expected Completion Date:
      •  Comments:
      •  Approved By:
 

As an option, I can also provide;

1. Gantt Chart with listing of Observations

2. Excel Spreadsheet listing of Observations

Report Example Writing:

Example 1

Example 2

Example 3

Example 4


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