Curriculum Vitae (CV)

By Mark Gunn
MGD Services

If a Software development project is for an FDA regulated industry, the application must be validated. In this article I will address the role of the Curriculum Vitae (CV) or resume, in the audit process. The importance of the CV and its role can often be overlooked. A CV of each project participant, whether employee or consultant, is required to be kept on file and be part of the validation library. More importantly all CVs must be kept up to date with a complete description of each project participant’s job responsibilities. Many people who work on FDA validated projects assume that having a CV for all project members is all that is required. While true, many forget to update them when project members change or gain responsibilities. The CV provides a trail for an auditor to follow when they are reviewing such essential details as whether the signatures they are reviewing have been made by someone who has the authority and skill required to approve and sign validated project documentation.

During an audit, an auditor will review the Project’s Organization Chart, Job Descriptions and all project participant CVs. The auditor is looking for the organization chart to list the following:

¨ A complete list of project participants and their titles
¨ Relationships between project participants and whether these are direct, indirect or dotted line relationships.

They will compare the person’s name and position on the organization chart to the job description for that position and compare those to the person’s CV. Again, they are checking to see that each person is qualified to perform the duties of their position and that their CV provides the proof of their qualifications. As you can see, consistency is critical. This is only one example of what happens when an auditor is hot on an audit trail… look forward to more examples in future articles.