FDAnews Announces Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections Webinar June 9, 2021
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WCG FDAnews Organizing Data and Document Archives:
Finding a Needle in a Haystack for FDA Inspections
An FDAnews Webinar
‘Now, where is that darn document?’
Paper documents unscanned. Naming conventions that don’t make sense. Emails as GXP documentation. Poor communication with the vendors that generate the data. Non-functional (or non-existent) SOPs. Documents missing altogether. Yes, data retrieval is in a sorry state at far too many drug, device, biologics and diagnostics companies.
But the next inspection day doesn’t need to become a scavenger hunt. Create effective new SOPs for electronic document management or improve existing ones. It’s easy when one knows how.