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The other day a friend asked me what a tester does. In other words what is software testing? What’s a bug? What are the key terms associated with testing? This is a humble attempt to address these questions and ini

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

tiate the uninitiated to the world of testing.

Software Testing is a process of software analysis and defect detecting. It’s the art (pun intended) of identifying as many defects as possible in order that they can

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

be fixed. A Defect (bug) is the non conformance to requirements or functional specification. It is something that does not correspond to valid Customer’s expectations that are assumed but may be not described in pr

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

oduct requirements.

The Test Manager in conjunction with the Project Manager develops a Test Plan which describes what, when, how and who will be involved in the testing process. This basic document also describes

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

a list of tested components, quality criteria and risks of testing, resources and graphs of testing, testing strategy and testing types test budget etc.

The test lead/ senior test Engineer develops Test cases whic

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

h is basically a set of test inputs, execution conditions, and expected results developed for a particular objective, such as to exercise a particular program path or to verify compliance with a specific requiremen

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

.

Classification of Testing Types:

Static Testing is a process, which is used for verifying any work product in terms of code, requirements, functional specification, architecture and design documen

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

ts, etc. Static testing is one of the most effective ways of defects detecting in the early stages of a product process.

Dynamic Testing Dynamic testing consists of launching the program, running all functi

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

nal modules and comparing the product’s behavior with expected one using user interface.

Black box testing. Testing software based on functional and business requirements at launching and operating it witho

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

ut knowledge of the internal structure or program source code. A tester tests a product so as an end-user would work with it at the time of its launch and operation. This method checks the proper working of all fun

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

tions and whether they conform to functional requirements.

White box testing (glass box testing). The Tester uses his or her understanding of source code and accesses the code to develop and execute test ca

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ses. This method tests the architecture of the system. It tests the design and programming that goes into building system. White box testing is usually applied when application is not entirely assembled, but it’s n

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

cessary to check each of the components, modules, procedures and sub-functions.

Unit Testing. This level of testing is usually carried out by the software developer to perform the testing of a separate modu

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

le of the system. It may be a testing even of any particular part of the code (class).

Integration Testing. Is the testing of various components of an application (in their integrated form) to determine if

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

hey function well together. Also, interactions between applications of big system can be checked with this type of testing. In this case this testing is known as Cross-product testing. Usually it is performed after

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

unit and functional testing has been carried out.

System Testing refers to that type of testing which checks the operation of the system as a whole. It is usually associated with the testing of the functio

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

al as well as non-functional requirements of the system.

Functional testing is the process of attempting to find discrepancies between the program and its functional requirements or specifications. Its goal

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

s are

1. Defining defects in software product and its documenting

2. Determine if software meets its requirements as defined in the Software requirements Specification (SRS) and other relevant documents.

3. Take

.

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

an objective decision about possibility of software product delivery to customer; the decision should be documented in test result report.

Smoke Test It is the first and the shortest test, which checks the

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

basic functionality of software product. This test takes approximately 1-4 hours depending on program complexity, A smoke test helps the Test lead to take a decision as to whether to continue further testing or not

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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