Observations

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The Observations page lets you set up filters to build reports of observations that are customized for your business.  Filter options include:

  • Date
  • FDA Issue – Keyword
  • Groups
  • Industry
  • Document Type
  • Geographic Area
  • CFR Part
  • FDA Project Area

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OVERVIEW

The Observations page is sometimes called the “Barb Report”—it is named after Barbara W. Unger, Govzilla’s Senior GMP Expert, who wanted to build reports of specific types of observations that were filed in specified date ranges, for companies in certain industries.

The Observations page leads you through options to create reports that have the information you want to focus on.

MAIN FILTERS

Two filters are required for any search—Date and FDA Issue – Keyword.

Using this report searches the thousands of 483s that we have in stock that are retyped and searchable by keyword.

OPTIONAL FILTERS

To further filter results, there are additional options to filter within your Groups or by FDA Industry, Document Type, Country, Region, CFR Part, and FDA Project Area.

OBSERVATION DETAILS TABLE

When the search results are available, they are displayed in the Observations Details Table.  Here you can sort, filter even further, and click through to both sites and inspections.

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