The Do’s and Don’ts of Audit Readiness

February 7, 2014

  • eTMF Best Practices

In preparation for Troy Deck’s presentation “Utilizing eTMF as a Tool for Audit Readiness,” Kathie Clark and I interviewed a number of industry professionals from top pharmaceutical companies on their experiences with audits from the MHRA, FDA, EMA and PMDA. These insiders were able to share valuable insight into audit preparation, as related to the Trial Master File in paper and electronic forms.

The overwhelming message from these interviews cautions those involved in the audit that “there is not much you can do at the end of the day if you have not been following good processes all along.” Here are the “Dos and Don’ts” from the pros:

Do:

  • Focus on completeness and scrutinize the list of documents for the study
  • Make sure document owners understand their docs and what is in their TMF (and if applicable, what is in other locations)
  • Test inspector set-up very thoroughly
  • Make sure that study team truly understands the transparency that eTMF provides and what the inspector will see

Don’t:

  • Rely on FDA experience to establish expectations for an EU study
  • Assume that the inspector will not be tech savvy
  • Assume that inspectors won’t want to access the system directly and without supervision (even FDA)

What is your number one piece of advice for audit readiness? Share it in the comments section.

For more information, check out the full presentation.