Preparation is Key for a Successful eTMF Inspection

Failing to prepare is preparing to… well, it’s not really preparing at all.

Receiving notification of an impending inspection can cause panic for TMF owners but, with the right preparation and tools, stress can be minimized.

Here, we look at two key areas of focus for inspectors today, how to prepare appropriately, and what it truly means to be inspection ready.

What Inspectors are Looking for Now

Increasingly, inspectors are interested in two key things when conducting inspections:

1. Direct access to TMF documents – the preferred method for accessing these documents varies by agency. The US Food and Drug Administration (FDA) expects the sponsor/CRO to work with them to navigate the system, or methods, used to manage TMF. Conversely, the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) prefer to be unsupervised. Regardless of favored approach, it is important to make TMF access and navigation easy and ensure related documents can be viewed together.
2. To review metrics related to TMF completeness, quality, and timeliness – inspectors need to see when documents are created in eTMF and will expect explanations for any surges in document uploads. They don’t want to see a spike of activity immediately after an inspection is announced.

Preparing for Inspections

Don’t just focus on immediate actions once an inspection is announced; you should also think about the activities you will need to perform before, during, and after the inspection. Below are some key actions to take:

System set-up – Establish how inspectors can view and find appropriate documents and what they can do with them. Remember to link to relevant documents situated outside the eTMF. The system set-up should be done in advance and the process should be documented in an SOP.

Team set-up – Form an inspection team – including QA, IT, business support, and business lead representatives – with clearly defined roles and responsibilities. The team should develop and deliver an inspection process covering inspector training and access, issue tracking, daily closeout meetings, inspection debrief, and management of findings.

Inspector training and access – Ensure you plan appropriate systems training for the inspectors; this should last no more than 20 minutes. Inspectors simply need to know how to navigate the system to find documents that meet the scope of their inspection. The inspector should be given access to all “final” documents. It’s not recommended you share non-final documents.

Inspection Readiness is not a Preparation Activity

Inspection readiness is an ongoing process that, when fully leveraged, enables a constant state of inspection readiness for your organization.

When actively managed, the TMF is checked for quality and completeness at every step of the process, not simply at the time of TMF upload. Trial processes and the TMF are interconnected to ensure end-to-end visibility into TMF accuracy, timeliness, and completeness.

To learn more about embedding a culture of inspection readiness in your organization, read this blog.