Most clinical and compliance groups spend the vast majority of their time planning. They plan for best quality assurance practices, prepare in case of a regulatory inspection, devise responses to questions during an inspection, and even strategize for future inspections in the midst of an ongoing inspection.
Today, the vast majority of inspections are conducted on-site, with the inspector accessing TMF content directly from the filing room or the in-house system. Having a regulatory inspector come on-site not only requires meticulous preparation, but also adds logistical considerations that can often overwhelm those undergoing their first inspection.
While regulatory inspections are incredibly important for patient and public safety, are there better ways to prepare and conduct inspections with regulatory agencies, without completely crippling your team’s productivity - such as moving towards off-site methods for undergoing an inspection?
In the following article, we’ll be exploring how TMF inspections are performed today with some examination of the regulatory expectation, as well as looking at what technological advancements are required to support a change in how inspections are conducted.