Good Documentation Practices

Following good documentation practices, in compliance with FDA regulations, helps ensure control over your processes and is a critical element of Data Integrity. Proper documentation tells what you did, when you did it, and how you did it. These are important factors when reviewing GMP documents for audit reviews, out-of-specification and deviation investigations, and daily product release and document approval. 

This course can be customized to meet your company’s specific needs. You can select from our listed topics or we can incorporate other relevant topics that you request. 

Examples of 483s, Warning Letters or other official action will be included, as appropriate.

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Suggested Topics

  • Why do we document?
  • What makes a quality document?
  • Correcting documents
  • Using the correct writing instruments
  • Personnel responsibilities
  • Document review/verification
  • Consistency of data entry
  • Use of abbreviations
  • Handling of raw data
  • Recording data
  • Signatures

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