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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
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Shipping: Available for download - Link will be provided in My ComplianceOnline section
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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