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Computer System Validation (CSV) Online Test

Topics Covered

  • Shell Scripting
  •  OpenEdge Replication
  •  OpenEdge Operations and monitoring

Useful for hiring

  • Computer System Validation Expert (Pharma)

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Talent Acquisition Manager
Question

Analyze the given statements regarding the application of Corrective Action and Preventive Action System Throughout the Product Lifecycle and select the correct option?

Statement S1: While discontinuing the product, the impact on product remaining on the market should be considered
Statement S2: CAPA should be discontinued only after the product is discontinued

Answer
    • Only Statement S1 is correct

    • Only Statement S2 is correct

    • Both the statements are correct

    • Both the statements are false

Question

There is a data center which is currently in audit testing phase. A meeting with the appropriate site managers has been called for some reason. Which of the following is likely not part of the agenda for this meeting?

Answer
    • Data collection methodology and strategies

    • Data collection - what data to collect

    • Solving immediate problems

    • All of the mentioned can be part of the agenda

Question

Is it mandatory for Standard Operating Procedures i) to comply with the CSV policy and any business unit policies that may apply ii) to get approval from the appropriate management for that site or department?

Answer
    • i) is mandatory, ii) is not

    • ii) is mandatory, i) is not

    • Both are mandatory

    • Neither i), nor ii) is mandatory

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