Managing Data and Documentation for FDA Inspections

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Managing Data and Documentation
for FDA Inspections

Do you understand the FDA’s document access authority? Is your company’s data and documentation organized and ready for your next FDA inspection?

If not, your next inspection could become a scavenger hunt.

Managing Data and Documentation for FDA Inspections will help you get control of your data by using industry best practices and SOPs.

You will also learn:

  • Documentation the FDA is entitled to see;

  • Documentation the FDA is not entitled to see;

  • How to create unique naming conventions to handle masses of data;

  • How to prioritize data that might be requested during an inspection;

  • The “Top 10” questions to ask about your archival process;

  • What to do when documents are not in the general archives;

  • When does email count as documentation;

  • 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; and

  • Tips for dealing with more than one “original.”


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PDF Edition

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Table of Contents

  • Introduction
  • The FDA’s Document Access Authority
  • Managing Documentation
  • And More …

View the entire TOC

Who Will Benefit

  • QA/QC managers and staff
  • Document managers and staff
  • Regulatory affairs managers and staff
  • IT managers and staff

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