This template package features a comprehensive audit checklist and scorecard that can be used to perform internal and external audits of facilities following FDA, ISO, & EU regulations.
If you are working on a biotech, pharmaceutical or medical device regulatory audit, this checklist provides the following:
- The checklist can be utilized to complete internal or external audits of licensed facilities which are required to follow the ISO, FDA, and EU regulations outlined in the document.
- The checklist is broken into 21 independent audit elements (each with its own tab in the spreadsheet).
- Each element contains a series of questions that correspond to and are cross-referenced by several well-known regulations.
- Each question is assigned a weight, from "Minor" to "Critical", which corresponds to the relative significance of the question and the subsequent requirements. The higher the number, the higher the significance.
- Guide Notes are provided to ensure that the user of the checklist has relevant examples of the regulatory requirement.
- The user of the checklist completes each audit element by filling out the scores for the 21 elements. The user will score the auditee for each question, providing a numerical value equal to the weight when the auditee has shown evidence of meeting the full intent of the regulatory requirement. The user will subsequently record scores based on the responses, down to a zero(0) if the auditee is not meeting the intent of the regulation.
- Upon completion of the checklist, it is recommended that the user capture objective evidence for each question.
- After each element and its subsequent questions have been answered, a total score will be updated automatically at the bottom of the list of questions and in the Summary tab for the evaluation.
- The total score is calculated automatically and provides the facility with a quantitative evaluation of how well it is meeting the regulatory requirements included in the 21 elements. The user may then set an acceptable or "passing" grade for the audit based on the results.
- This audit checklist will serve as an excellent basis for an internal or external audit process.
