Scripted vs Unscripted Testing: what’s the difference?

 

Data Integrity App

Scripted vs Unscripted Testing: what’s the difference?

Traditionally each test script was written in great detail, regardless of whether the system or feature was a Direct or Indirect system or feature.

So, the same level of effort was being put into creating test documentation for low risk systems or features and high-risk systems or features. CSA introduces the terms Scripted Testing and Unscripted testing.


Let’s examine these terms: 

‘Scripted Testing’ 

  • ‘Scripted Testing’ is what we would know as traditional testing. Scripted tests as we know usually contain at a minimum a test Objective for the test script, a step-by-step test procedure, Expected Results and a Pass/Fail. Scripted Testing is to be used to test to higher risk (Direct) systems or features as the software does directly impact the product or patient safety.
  • Scripted testing requires significant preparation and follows a prescribed step-by-step method with expected results and pass/fail outcomes. It is based on pre-approved protocols (IQ, OQ and PQ).
  • This is the traditional testing method associated with the CSV methodology. CSA advises us to reserve scripted testing for high-risk features and systems.

Unscripted testing’ 

  • ‘Unscripted testing’ is testing that is carried out without the use of detailed test scripts. Unscripted Testing is to be used to test lower risk (Indirect) systems or features as the software does not directly impact the product or patient safety but does impact the quality system. There should be a Test Objective and a Pass/Fail, but no step-by-step test procedure.
  • Unscripted testing requires no preparation, documentation or test scripts. It's less time-consuming than traditional testing. We should reserve unscripted testing for low- to medium-risk features and systems that do not directly impact product or patient safety.

 

  • Ad hoc, automated and exploratory testing are examples of unscripted testing methods that I explore in detail in my podcast, which you can access by clicking on the link below.


“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.

Data Integrity App


 

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.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

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