How to handle Discrepancies during Computer System validation?

 


In Earlier post we understood What is Qualification protocol (IQ/OQ/PQ/IFQP), Its Necessity & When requalification performed in CSV? Computer system validation?

 

Now in this article we are going to understand How to handle Discrepancies during Computer System validation?

What is Discrepancy?

Datum or result outside of the expected range; an unfulfilled requirement; may be called nonconformity, defect, deviation, out-of specification, out-of-limit, out-of-trend

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Discrepancy Form:

It is form on which any discrepancy observed during computer system validation process has been recorded.

Quality Assurance Team shall issue the Discrepancy form & assign unique number to each Discrepancy & maintained log for the same.

Discrepancy Form must include:

•      Discrepancy Details,

•      Type of Discrepancy,

•      Severity of Discrepancy,

•      Discrepancy occurred & Recording Date,

•      Discrepancy Identified By,

•      Target Complete Date,

•      Root Cause why discrepancy occurred,

•      Rectifications / Corrective Actions taken for all type and severity of Discrepancy etc.

Discrepancy Log:

In Discrepancy Log maintained Log of all discrepancy observed during computer system validation process.

It include Discrepancy Number, Recorded by, Date of Discrepancy & Resolution status of Discrepancy

Finally same Discrepancy Log should be reviewed by Quality assurance team.

How to handle Discrepancy?

All discrepancies that occur during qualification Testing should be documented on Discrepancy Form.

The all details of all discrepancy forms should be recorded on Discrepancy Log which should summarize all the discrepancies that occur during the execution of the qualification Tests

All discrepancies status should be recorded in Qualification Report. Based on impact of discrepancy, risk assessment may be required to perform for that particular requirement and propose mitigation (procedural or technical) to close.

Categorization of Discrepancies:

•      Discrepancy Type

•      Discrepancy Severity Level

•     

       Discrepancy Type. 

       All discrepancies that occur during Qualification Testing will be assigned a discrepancy type as follows:

•      System; The discrepancy is due to a failure of the application software.

•      Environmental/Setup: The discrepancy is due to environmental and/or configuration parameters being set up improperly.

•      Script: The discrepancy is due to the test script being incorrect.

•      Tester: The discrepancy is due to an error on the Tester’s part when executing the test script.

•      Other: The discrepancy is due to causes not covered by the above mentioned Discrepancy types.

•     

      Discrepancy Severity Level: All discrepancies that occur during qualification Testing will be assigned a severity level as follows:

•      Critical

•      Major

•      Minor

•      

      Critical: A discrepancy determined to have a potential impact to product quality, purity, strength, and integrity, an event representing a significant breach of GxP or a failure of a GxP system 

•      Major: A discrepancy determined to have no impact to product quality, purity, strength, and integrity. Impact to product and / or process can be determined through preliminary analysis of data available at the time of discrepancy. No evidence of a failure in GxP systems. 

•      Minor: Not a GxP failure, no product impact

“Trust but Verify “ Ronald Reagan

 

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If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

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Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

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- Basic Data Integrity Concepts

- ERES & Its Requirement

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