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E-Folder - How to Write Good Use Cases for Useful Business Analysis
A use case details a flow of events that are executed in order to accomplish some business task. A use case can
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
be as simple as documenting how a help ticket gets escalated or as complex as defining how a customer gets charg
; 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
d for shipping parts of an order to multiple addresses.
The term "actor" is used to define a role that a person
The term "actor" is used to define a role that a person
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
or some object plays in executing a use case. The actor might be a Customer Service Representative who is proces
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ing a refund request, or a server that processes credit card transactions.
Writing usable use cases is an excel
Writing usable use cases is an excel
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
lent way to derive functional requirements and to the software development process as a whole.
Often times new
Often times new
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
nalysts, or people finding themselves in an analyst's role with no training or experience, often wonder what sho
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
ld go into a good use case. Although some organizations may have strict requirements that conflict with the info
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
mation presented in this article, you can safely assume that you'll cover all of the normal essential elements i
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
f you follow these tips:
- Use Descriptive Names The name of the use case should leave no doubt as to its purp
- Use Descriptive Names The name of the use case should leave no doubt as to its purp
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
se. A name like "Contact Past Due Customers" is better than "Collections".
- Assign a Unique identifier to Each
- Assign a Unique identifier to Each
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
Use Case
Assigning an identifier or label to each use case makes it easier to refer to a use case in other proj
Assigning an identifier or label to each use case makes it easier to refer to a use case in other proj
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
ct artifacts.
- Create a use Case Summary
Creating an "executive" summary allows other stakeholders to gain a
- Create a use Case Summary
Creating an "executive" summary allows other stakeholders to gain a
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
high-level understanding of the use case's purpose without having to read the entire document.
- Use Case Frequ
- Use Case Frequ
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
ncy
Document how often this use case is executed by the actors.
- Use Case Preconditions
Document any situati
Document how often this use case is executed by the actors.
- Use Case Preconditions
Document any situati
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
ns or conditions that must exist prior to the use case being invoked.
- Use Case Post-Conditions
Document any
- Use Case Post-Conditions
Document any
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
onditions that must be true or false after the use case is invoked.
- Basic Use Case Logic
Document the main o
- Basic Use Case Logic
Document the main o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r happy path that the user takes throughout the use case.
- Alternate Paths
Document all paths that exist as t
- Alternate Paths
Document all paths that exist as t
.
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
e result of exceptions or errors in the main or happy path.
- Group Memory
Document all critical decisions tha
- Group Memory
Document all critical decisions tha
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
were made during the creation of the use case in order to be able to ensure that the group memory is maintained
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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