What are Test Scripts/Cases?

What is a test script case

 

What are Test Scripts/Cases?

Test scripts (also known as test cases) should contain the instruction details of each test. The test script should be described in sufficient detail to enable the consistent repetition of the test.

Each test script should, where possible, include the following:

  • unique test reference
  • cross-reference to controlling specification
  • title of test
  • description of the test, including the test objective
  • test steps – step-by-step description of the actions to be performed by the testers along with the expected results
  • acceptance criteria – the defined set of expected results that should be met for the test to be deemed to have passed.
  • pre-test steps – including any test pre-requisites or set-up
  • data to be recorded – A description of the test-specific data to be collected and recorded. Also, the requirement for use of screenshots and other electronic documentation should be specified.
  • post-test actions.

Each test script or test case contains just one (1) type of testing or challenge. e.g. electrical installation verification, logging verification, etc.

The following figure shows an example of a test script to verify the electrical installation of a computerized system.

test scripts case description

 

test scripts case table

 

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For more details on specific FDA expectations and how to perform a Computer System Validation test script/case, follow us.

validation templates online

Three (3) Options to Create a Test Scripts / Cases in Computer System Validation Protocol:

Option 1. You Can Create Test Scripts in CSV Protocol, using a Template.

You can download samples of the validation templates in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs.

Option 2. We Can Bring You a Formal Training on How to build a Test Scripts in a Computer System Validation Using Our Template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We Can Create Customized Test Scripts and Computer System Validation Protocol.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

GET IN COMPLIANCE TODAY, CONTACT US (Hablamos Español)

References:

https://www.fda.gov/media/73141/download

Food and Drug Administration References

  1. Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995)
  2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002)
  3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)
  4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems ApproachExternal Link Disclaimer (FDA 2002)
  5. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
  6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1

Industry References

  1. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/)
  2. ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000)
  3. ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)
Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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