By Mark Gunn
The test cases are written by the quality assurance analyst in exacting detail from the business requirements documents, functional specifications, design documents, and technical specification documents. They are organized based on the use cases. The test cases will ensure that each of the use case conditions is met by the system. These detailed test cases are written in a standardized way to ensure the tester can execute the test and know the expected results to validate whether the test passes or fails.
Each test case will have the following information:
- A unique number and a description of the test case
- The requirement, use case and module being tested
- Any data preparation required to run the test case
- Any test cases run prior to running the test case
- The name of the person running the test case and date run
- Each step contains the action/procedure being taken, expected results, and pass/fail
Different test cases will be written and used for unit, function, and system integration testing. The systems integration test cases can be used for User Acceptance Testing.
The users can use the use cases and test cases along with real data to test the system to make sure that system meets all of the agreed upon requirements and business needs. The test cases can be used later in the process as a springboard for developing a User’s Guide, training documents, and for future system enhancements.
Test cases should never be too long or too short. What we mean by that is, an individual test case should not test across modules or cover multiple parts of the system. If test cases are written in this manor then one change to any one part of the system could mean rewriting many, many test cases. With some system integration test cases, this must happen but should be limited. If your test cases are ‘modularized” then if a change is made to one part of the system then only the cases that cover that part of the application need to be rewritten. This holds true for manual test cases as well as automated test scripts.
The test plan will cover how the test cases will be developed and how they will be organized. Thought must be given prior to writing the test case so that they are usable by all those testing the application. Having similar test cases written by several QA Analyst is a waste of time and is not the best way to ensure complete system testing coverage.
You have written your test cases and you are now ready for the development team to release the first build. What might help with this are release notes. More on this next time.
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Mark Gunn has 25 years experience in the Quality Assurance and FDA validation fields. If you have any questions about these topics, please email Mark at Mark@mgdservices.com
By Mark Gunn
MGD Services
We have had clients inform us that many on their staff believe that 21 CFR Part 11 is no longer in force. 21 CFR is still in force and in all likelihood will be for some time. Some of the confusion arose out of the adoption of the 21st Century cGMPs for the Pharmaceutical industry. This initiative allows the pharmaceutical industry to be smart about compliance while putting the burden of proof on the industry itself. It requires documentation of risk analysis (Risk Based Approach) and the impact on patient health, product quality and data integrity. While this does narrow the interpretation and scope of Part 11 it does not eliminate it.
The current interpretation of the Part 11 rule focuses on only those records required by predicate rules (GLPs, GMPs and GCPs) that are in electronic format. This means that fewer records are covered and that predicate rule requirements are still enforced. The FDA still expects systems to be validated based on the predicate rules. You should consider the impact on accuracy, reliability, integrity, availability, and authenticity of any documentation that has been identified based on the risk based approach. You should base the approach on a justified and documented risk assessment that evaluates the effect on product quality and safety and record integrity.
What is still being enforced for Part 11 compliance is comprised of the following areas:
- Security
- Accountability for e-signatures
- Electronic signatures
- Operational, device, and authority checks
- Record protection
- Training and experience
- Open systems
At a minimum the Validation Plan and Report, Requirements, System Acceptance Test, IQ/OQ/PQ, and Maintenance Procedures are required to be validated. But with only these minimum requirements there are liable to be gaps in compliance if the required documents are not comprehensive and issued in a timely manor. The risk based approach must not be looked at as a way around the regulations but as a more structured and fairer approach to 21 CFR Part 11 compliance.
Mark Gunn has 25 years experience in the Quality Assurance and FDA validation fields. If you have any questions about these topics, please email Mark at Mark@mgdservices.com
On April 30th, 2005 a determined and damp group known as the Band of Babes gathered with thousands of other fund raisers to walk or run in support of finding a cure for woman’s cancers. Our words of inspiration sounding similar to those imbedded in the stone of NYC’s General Post Office:
“Neither snow nor rain nor heat nor gloom of night stays these couriers from the swift completion of their appointed rounds.”
In the case of the Band of Babes, our mantra was:
“Neither rain nor wind nor water soaked sneakers stays these supporters from their trek from Times Square through Central Park in their search for a cure!”
As we waited for the race to begin, we listened as guest speakers, Julianna Moore and Mariska Hargitay exalted our fund raising efforts. The flashing neon of Times Square gave plenty for us to wonder over as well. Some huddled together for warmth, while others, no names mentioned (MARK) shook their water laden umbrellas over the shuddering masses, adding to their soggy plight. After a thirty minute stutter-step to the start line, we were on our way. Rain was still falling but we were moving and warming up. Our original plan was for some of the gang to act as ground crew and hold our luggage, and take action shots as we passed by. However, the weather being a deterrent, our sideline supporters opted to join the walk. Away we went, weaving our way through the throngs of people to the finish line where we gobbled potatoes chips washed down with Smart Water.
Our youngest member, nine year old Makenzie got a three mile piggy back ride from her very resilient mother, Bilynda. The Band of Babes raised $1,250.00 which will go to continued research for cures for woman’s cancers. Better weather has already been requested for next year’s event and we hope to see more new faces when we line up in Time’s Square next year!
For more information about race results or to make a contribution until
June 1, please visit: Revlon Run/Walk>Revlon Run/Walk
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