Test Script Planning and Execution: Scripted v/s Unscripted Testing

In the validation planning and execution process, it is essential to choose the right testing approach based on the risk level associated with the computer system. At Sagax, we help you make informed decisions about when to use scripted (high-risk) and unscripted (low/medium-risk) testing methods, ensuring that your validation efforts are both efficient and effective.

Scripted Testing (High-Risk Systems and/or Requirements)

Scripted testing is a formalized, structured approach that validates system requirements, ideal for high-risk systems with significant impacts on quality, safety, or compliance. Benefits include:

  • Ensures thoroughness and consistency in testing by following predefined steps and expected outcomes.
  • Provides a comprehensive record of test results, which is useful for regulatory audits and inspections.
  • Reduces the likelihood of human error by minimizing the reliance on the tester’s knowledge and judgment.

When to choose Scripted Testing

  • The system has a direct impact on critical process parameters (CPPs) or critical quality attributes (CQAs).
  • The system is subject to stringent regulatory requirements or scrutiny.
  • The complexity or novelty of the system makes it difficult to predict potential failure modes or consequences.

Unscripted Testing (Low/Medium Risk Systems and or Requirements)

Unscripted testing is a flexible and exploratory approach that actively seeks defects without predefined scripts. Ideal for low to medium-risk systems with less significant impacts on quality, safety, or compliance. Benefits include:

  • Encourages creative thinking and the identification of previously unrecognized risks or issues.
  • Allows for a more efficient use of resources by focusing on critical
    areas of the system.
  • Can be used as a complementary method alongside scripted testing to provide a more comprehensive assessment of system performance.

When to choose Unscripted Testing

  • The system has a low or medium impact on critical process parameters (CPPs) or critical quality attributes (CQAs).
  • The regulatory requirements for the system are less stringent, or the system has a proven history of compliance.
  • The system’s design or functionality is well understood, and potential failure modes or consequences can be reasonably anticipated.

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Contact Us & FAQ

    Q1. How long have you been offering services in Q&C

    Since 2018.

    Q2. Do you have in-house consultants to set up Validation requirements

    Yes, we have in-house CSA specialists.

    Q3. Is your team well versed with regulatory compliance format

     Yes, we have completed many successful projects due to our process and updates driven approach.

    Q4. What is the average experience of your consultants

    10 Years.

    Q5. How do I connect with you

    You can write to us at info@sagaxteam.com OR fill in the form on the “contact us” page and our team will get back to you.