Root Cause of Testing Issues

 

Data Integrity App

The Root Cause of Testing Issues

Testing is a fundamental and crucial part of computer system validation (CSV). Computer software assurance (CSA), the FDA's new methodology for performing CSV, won't change that.

The hope, however, is that CSA will streamline testing by encouraging us to rely less on scripted testing and pre-approved protocols and more on existing test/vendor records and automated tools in our testing efforts. In other words, CSA is designed to help us test smarter, not harder.


The Root Cause of Testing Issues

The foundation of good software, or software that performs as intended, is good requirements. The same is true with testing. If you want to write good tests, you must start with good requirements. Inferior or incorrect requirements are often the root cause of a testing problem.

User requirements define the intended use of the system. Functional requirements outline how the system must perform to meet those user requirements.

 

Finally, design requirements are the elements and components that must be in the system to develop the functional requirements that will, in turn, meet the user requirements.

 

Because they're interconnected, user requirements will have a domino effect on the overall safety and efficacy of the system. The effect can be negative or positive—it all depends on the quality of the user requirements.

 

Characteristics of a Good Requirement

Gathering and writing good requirements is a core competency for anyone tasked with writing test steps and test scripts.

A good user requirement should have the following characteristics:

·         Unambiguous

·         Testable

·         Clear

·         Correct

·         Understandable

·         Feasible

·         Independent

·         Atomic


 

Risk-based Testing and Least Burdensome Approach

Once you are satisfied with your requirements, it's tempting to dive right into testing. But before you can move forward, you must consider risk and the least burdensome approach.

Testing, at its core, is really about risk. This idea is not new. The FDA promoted a risk-based approach in its final guidance document General Principles of Software Validation, published in 2002.

 

A few years later, the International Society for Pharmaceutical Engineering (ISPE) introduced GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems.

 

Unfortunately, over-testing and exhaustively documenting every step of the testing process (even for low-risk systems or features) "just to be sure" has become the standard approach to CSV testing.

Maximizing testing efforts, regardless of risk, burdens resources and can even compromise patient safety. Testers often neglect—or entirely miss—high-risk issues when attempting to "test everything."

The CSA approach prioritizes risk-based critical thinking over excessive testing. It encourages a least burdensome approach to documentation and the use of less formal (and far less time-consuming) unscripted testing methods and automated technologies for digital validation.

Key Takeaway

The purpose of CSA is not to eliminate CSV or scripted testing. Its purpose is to remind us to use critical thinking combined with a risk-based approach to determine which system features are crucial to product and patient safety and focus our most rigorous testing efforts there.


“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

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.

 

“Stay One Step Ahead in Pharma IT Compliance” 


Data Integrity App Link:


https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.


 

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