Inspection Readiness Toolkit

An inspection has been announced and you want to prepare the TMF for the inspection. What do you need to think of and what activities are typically conducted to prepare for the inspection?

These and many other questions have been addressed through the work that has been performed by the ‘Inspection Readiness’ TMF Reference Model subgroup. The scope of the work was to develop a toolkit of inspection preparation checklists, lessons learned and other resources that are available in the public domain. In particular, the subgroup discussed activities that organisations typically undertake to prepare for inspections and the roles performing those activities. The subgroup looked into different options to consolidate this and make it usable for other organisations.

The outcome is that the subgroup has gathered best practices for preparation of the TMF for inspection and these activities are listed in the Inspection Readiness RACI. The toolkit can be downloaded free of charge from our Resources web page.

The Inspection Readiness RACI can be used both for paper TMF, eTMF and hybrid TMFs. It can be adapted with the roles specific to the organisation using it and will help structure the inspection preparations and give a clear overview of activities, roles and responsibilities.


Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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