Managing Data and Documentation for FDA Inspections
Paper documents unscanned. Naming conventions that don’t make sense. Emails as GXP documentation. Poor communication with the vendors that generate your 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 your 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 you know how.
Managing Data and Documentation for FDA Inspections will help you get control of your data by using industry best practices and SOPs.
How to create unique naming conventions to handle masses of data
How to prioritize data that might be requested during an inspection
About pinpoint searching and how to do it
How to develop assessments to gauge the risk of not being able to find a document
The “Top 10” questions to ask about your archival process
What to do when documents are not in the general archives
When emails do count as documentation
How to explain missing documents to investigators
If source data is electronic, how to provide access to the regulatory authority
If source data is paper that was scanned, what to do with the originals
Tips for dealing with more than one “original”
Develop systems and SOPs that ensure all your vital records will be at your fingertips when the investigator asks for them. Order your copy of Managing Data and Documentation for FDA Inspections today.
Order Your Copy Today
PDF Edition — $397
Who Will Benefit
QA/QC managers and staff
Document managers and staff
Regulatory affairs managers and staff
IT managers and staff
Lab managers and staff
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