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.
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
- Project coordinators
- Principal investigators
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