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Laboratory Failure Investigations

The FDA requires that an investigation be conducted whenever an Out-of-Specification (OOS) result is observed. This SOP defines the requirements for dealing with failed test results.

Provider: LabCompliance
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Price: $49.00
Product Details

  • The FDA requires that an investigation be conducted whenever an Out-of- Specification (OOS) result is observed. This SOP defines the Requirements for dealing with failed test results.
  • Upon completion of the analysis the analyst checks the results for Specifications.
  • The tests should be carried out by two different analysts in duplicate. The analysts should be different to the ones who did the original analysis.
  • Investigation reports should include: steps taken, raw data, supporting documents, findings and explanations, conclusions and recommendations to avoid occurrence of similar deviations in the laboratory.

It Provides information on:

  • Responsibilities
  • Frequency of use
  • Procedure.

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