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Useful Advices - Beta Testing, Anyone? 10 Potent Strategies for Achieving Success
Successful beta testing starts even before your system is born! Does that idea sound strange? It's not really that odd when you think that beta testing is meant to involve a methodical prove-in of a carefully designed system, such as an electronic device, Web site, or au
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
tomated tool. It's not meant to be a hit-or-miss, cross-your-fingers-and-hope-everything's-OK Band-Aid that you can apply at the last minute.
We've all seen examples of software programs -- even from well-known, respectable software companies -- that arrive on our deskt
We've all seen examples of software programs -- even from well-known, respectable software companies -- that arrive on our deskt
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ops barely breathing. They seem to be full of bugs, and thereby cause us more grief than they help us carry out work. Or we try to use a Web site that looks great, but we can't get from the shopping cart to the order page. Or we buy a new widget, yet even using the instr
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
uction booklet, we can't jump from the main menu to the critical functions the way we're supposed to.
Are you anxious to catapult your business into the ranks of companies that frustrate their customers this way?
Of course not! Therefore, I'm confident that you will do
Are you anxious to catapult your business into the ranks of companies that frustrate their customers this way?
Of course not! Therefore, I'm confident that you will do
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
things differently.
That's why testing involves such a systematic, tedious, yet indispensable sequence of activities. Without a method to the madness, you're not doing anything more than randomly banging on the system to see if by chance you can find a way to break it.
That's why testing involves such a systematic, tedious, yet indispensable sequence of activities. Without a method to the madness, you're not doing anything more than randomly banging on the system to see if by chance you can find a way to break it.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
So, what do you need to know to properly estimate the effort, carry out the process, and keep the testers happy? Here are 10 strategies for achieving testing success.
1. Design test scenarios.
What's a "test scenario"? Each test scenario should be mirror image of a "u
1. Design test scenarios.
What's a "test scenario"? Each test scenario should be mirror image of a "u
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
se scenario" that's been guiding a team to design and develop the system. A use scenario describes one typical interaction a customer has with the system. For instance, for an automated teller machine, one scenario involves a customer inserting a card in order to withdra
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
w some cash. In another scenario, a customer makes a deposit. In another, he or she checks the balance.
Scenarios must represent any plausible ways in which users could interact with the system, including unusual and unintended actions. So both use scenarios and test sc
Scenarios must represent any plausible ways in which users could interact with the system, including unusual and unintended actions. So both use scenarios and test sc
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
enarios should account for possible error conditions such as jammed cards, cancelled transactions, or overdrawn accounts.
2. Write a test procedure.
A test procedure specifies how testers will exercise the test scenarios, including the order to follow. In the ATM examp
2. Write a test procedure.
A test procedure specifies how testers will exercise the test scenarios, including the order to follow. In the ATM examp
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
le, it might say, "Test withdrawing cash denominations in this order: $20, $30, $50, $100. Run another test in reverse order: $100, $50, $30, $20. Then run several tests in random order." It should also explain what results to expect in each case.
You'll want the proced
You'll want the proced
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ure to test all new system features or changes. You'll also want the procedure to test features in various combinations. For example, you might specify 1) withdrawing cash, then 2) checking balance information, and then 3) making a deposit. Be sure to vary the order, and
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
test error conditions.
3. Determine what data you need.
If your system stores values in a database, you'll need to load some typical data to test the scenarios. In the ATM example, values would include account balances -- for testing withdrawal limits and giving balan
3. Determine what data you need.
If your system stores values in a database, you'll need to load some typical data to test the scenarios. In the ATM example, values would include account balances -- for testing withdrawal limits and giving balan
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ce information. Create the sample data sets and pre-load the systems to be tested. Don't forget to include extremely high and low values!
4. Plan specific roles for testers.
Schedule each tester to focus on specific test scenarios and related data sets. If there are en
4. Plan specific roles for testers.
Schedule each tester to focus on specific test scenarios and related data sets. If there are en
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ough testers, assign more than one to cover each test scenario. Each person will approach it differently.
5. Create a bug reporting system.
It could be designed as a form, a database, an e-mail message, or a combination. Have testers submit bug reports as they find err
5. Create a bug reporting system.
It could be designed as a form, a database, an e-mail message, or a combination. Have testers submit bug reports as they find err
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ors in each round of testing.
6. Establish a test schedule.
The schedule should allow for several iterations of beta testing. Be sure to clear the schedules of testers for each round in which they will be participating.
7. Get all materials ready for testing.
The fol
6. Establish a test schedule.
The schedule should allow for several iterations of beta testing. Be sure to clear the schedules of testers for each round in which they will be participating.
7. Get all materials ready for testing.
The fol
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
lowing items should be ready for the kickoff meeting: A new or updated system, lists or descriptions of any bugs fixed, new or updated documentation, test scenarios and procedures, and so on.
8. Set a start date.
On the start date, hold a kickoff meeting! Also schedul
8. Set a start date.
On the start date, hold a kickoff meeting! Also schedul
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
e progress checks. If testers find numerous bugs -- or especially critical ones -- before reaching a given checkpoint, stop testing, fix the bugs and/or documentation, and return to Step 1. Ask before restarting: Are new test scenarios or data sets needed?
9. Perform a
9. Perform a
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
new round of testing for each new test baseline.
This means starting the complete test from scratch after each round of fixes. You can't sidestep this requirement, because each time something is fixed, it can "break" something else. Stop the cycles of testing only when
This means starting the complete test from scratch after each round of fixes. You can't sidestep this requirement, because each time something is fixed, it can "break" something else. Stop the cycles of testing only when
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
no new bugs are evident.
10. Plan a reward for a job well done.
Testing is very tedious -- so testers need a special incentive to keep them focused on the goal. Although they're helping to produce a high-quality system, a post-testing party never hurts morale!
Thoroug
10. Plan a reward for a job well done.
Testing is very tedious -- so testers need a special incentive to keep them focused on the goal. Although they're helping to produce a high-quality system, a post-testing party never hurts morale!
Thoroug
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
h beta testing is essential for producing quality systems. If you discover errors you can't fix in time, you could decide to release a system with known defects (documented in your "Read-me" notes). The stakes can be high, so weigh this option carefully before proceeding
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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