Most of us aren’t aware of the full extent in which digitization and AI technologies can impact the histopathology lab. However, over the last 25 years, we’ve seen a period of extraordinary development of digital pathology in diagnostic research and drug development.
The doorbell rings and waiting at the front door are FDA inspectors... What do you do? First, welcome them in. Second... DON’T PANIC! Unless directed “For Cause”, FDA visits are routine inspections used to assess your lab’s compliance with applicable regulations and to verify the quality and integrity of your study data.
Preclinical research studies generating data for submission to the Food and Drug Administration (FDA) must adhere to Good Laboratory Practices (GLPs). These practices embody a set of principles that guide how laboratories plan, perform, monitor, document and archive study activities in an effort to enhance the quality and validity of test data. Below, you’ll find some practical tips on finding the right archiving facility for the long term storage of your study materials:
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