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Testing of CSV

The document discusses factors that influence testing of computerized systems. It covers test planning, coverage, management processes, cases, execution, and review. Key points include the need for sufficient test coverage of intended functionality and risk controls, and focusing on errors impacting patient safety and product quality over minor errors.

Uploaded by

Abdou Soudaki
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© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
181 views

Testing of CSV

The document discusses factors that influence testing of computerized systems. It covers test planning, coverage, management processes, cases, execution, and review. Key points include the need for sufficient test coverage of intended functionality and risk controls, and focusing on errors impacting patient safety and product quality over minor errors.

Uploaded by

Abdou Soudaki
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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// // ISPE® | Gamp® - GAMP5 Second Edition – Critical Thinking – Appendix D5

TESTING
OF
COMPUTERIZED SYSTEMS

PART-1
Contact Us for Implementing GAMP5 | E-mail: info@techqualitas.com
// // ISPE® | Gamp® - GAMP5 Second Edition – Critical Thinking – Appendix D5

What can we learn from this appendix

1 3 5

Influences on Testing as per


Test
Test activity Software category
Environments (Practical consideration of
(Identify influencing factors (Use of different test
on section of testing test selection)
environment with benefits)
method)
2 4

Types of Leveraging
Testing pervious testing
(Selection of correct testing (Focusing early test
method depending on selection)
system complexity and
novelty)
Contact Us for Implementing GAMP5 | E-mail: info@techqualitas.com
// // ISPE® | Gamp® - GAMP5 Second Edition – Critical Thinking – Appendix D5

Criticality of business
process & GxP Impact
supported by the system
Level of Test System
Automation Requirements
What
Other Controls Influences SDLC & Quality
in Business Testing System of
Process approach?? Supplier

Company Risk Culture Internal CSV policies

Contact Us for Implementing GAMP5 | E-mail: info@techqualitas.com


// // ISPE® | Gamp® - GAMP5 Second Edition – Critical Thinking – Appendix D5

Influencing factors Test Planning

Why Test Planning is required?

-To ensure sufficient test coverage of system intended functionality and risk controls against
GxP functions.

 Test Coverage should cover Intended Use of the System.

 Test Documentation will depend on Risk & Impact of functions on Patient Safety, Product
Quality & Data Integrity.

Contact Us for Implementing GAMP5 | E-mail: info@techqualitas.com


// // ISPE® | Gamp® - GAMP5 Second Edition – Critical Thinking – Appendix D5

Influencing factors Test Planning Test Coverage

Overall test coverage is combination of :


 Supplier Testing: Supplier assessment should be robust and verifying
suitability for expected services with fulfilling SDLC requirements and
compliance giving scope to leverage testing in the later phase.

 Scripted & Unscripted Testing: Selection of correct and required


testing method to detect possible defects (using unscripted Unscripted
testing method) and test functionalities of risk controls Test
Scripted Supplier
(with scripted testing). Test Testing
UAT
 User Acceptance Testing: This should demonstrate and ensure
the fitness of system for its intended use.

Contact Us for Implementing GAMP5 | E-mail: info@techqualitas.com


// // ISPE® | Gamp® - GAMP5 Second Edition – Critical Thinking – Appendix D5

Influencing factors Test Planning Test Coverage Test Management Processes

To ensure smooth functioning in operational phase with/without minimum


low risk defect, it is important to strategized test management process,
covering efficient testing in early development and verification phase.

Key factors :
 Pre-requisite & personnel requirements
 Test evidences expectations
 Type of environment using for testing
 Monitoring of testing and results
 Review and approval process of test results.

Contact Us for Implementing GAMP5 | E-mail: info@techqualitas.com


// // ISPE® | Gamp® - GAMP5 Second Edition – Critical Thinking – Appendix D5

Influencing factors Test Planning Test Coverage Test Management Processes Test Cases

The type and detailing of test cases depends on the test strategy, system
complexity and associated risk factors.

Type of testing –by designing of test cases

Scripted Testing Unscripted Testing


Detailed test cases that defines Test cases limited to establishing high
step-by-step instruction to be level test plan objectives.
followed by the tester.

Contact Us for Implementing GAMP5 | E-mail: info@techqualitas.com


// // ISPE® | Gamp® - GAMP5 Second Edition – Critical Thinking – Appendix D5

Influencing factors Test Planning Test Coverage Test Management Processes Test Cases Test Execution

The factor need to be consider to maintain quality of testing:


 Tester should be skilled and having knowledge of business process.
 Tester should have knowledge of the system under test.
 Execution tem & end users should be trine on test procedure.
 Demonstration of system operation should be provided. Automated testing
tool should be
 All trainings should be documented. encouraged.
 Test equipment should be calibrated & documented.
 Good Documentation Practices should be followed to record testing activities.
 Evidences should be retained and available for inspection.
 Unscripted testing evidences should be clearly showcasing pass/fail result.
 Fail results should be added with detailed description helping root cause.
 Before and after evidences should be covered for comparative objectives.

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// Review & Reporting of Completed Tests

Influencing factors Test Planning Test Coverage Test Management Processes Test Cases Test
Execution Review and Reporting

The factor need to be consider during review:


 Verify that system is deemed fit to intend.
 Completeness & accuracy
 Unusual failure condition should be investigated.
 Main focus should not be on minor GDP error with less impact on patient safety, product
quality or data integrity.

Contact Us for Implementing GAMP5 | E-mail: info@techqualitas.com


// // ISPE® | Gamp® - GAMP5 Second Edition – Critical Thinking – Appendix D5

// Lesson Learnt

“Errors that impact product quality should trigger more detailed investigations compared
to a catch and correct in the moment approach for less significant typographical errors”

Contact Us for Implementing GAMP5 | E-mail: info@techqualitas.com


// CONTACT INFORMATION

info@techqualitas.com

Contact Us for Implementing GAMP5 | E-mail: info@techqualitas.com

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