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If yours is a business with several departments, at one point you start to realize that in order to stay competitive, increase productivity and bring efficiency to your business, you need to optimize and automate some of your business processes. To identify which parts of your business activities are required to be optimized, first you need to have a

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

clear understanding of the processes involved in your particular business.

What is a Business Process?
A business process is a series of specific, measured tasks performed by people and systems and designed to achieve a predetermined outcome. The processes have these important characteristics:

The processes

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

Examples of combination products may in

have internal and external users.

They take place across or between organization’s departments or different organizations.

They are based on how work is done in the organization.

The business processes have three key elements - Entity, Object, and Task.

Entities: Where the process oc

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

urs.
Objects: The processes are results of handling objects. Objects could be physical or informational.
Tasks: Works done to handle the objects.

The followings are examples of business processes:

Mortgage application processing
Credit verification
Product development
Travel planning
Opening

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

new account
Answering to a Request for Quote
Shipping a product

Companies are trying to improve their business processes using computer technology starting ever since the computer technology has emerged. Initial emphasize was given to enterprise resource planning. Main areas where automation was adopted were production, accountin

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

Combination pro

, procurement and logistics. The next step was sales and marketing automation. Next came customer relationship management and supplier relationship management. Last couple of years we are seeing implementation of Business Process Management across the board. Companies are adopting BPM in the areas where it could make real differences. Some of these pr

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

cesses involve several departments of the company and some are result of real-time interaction of the company with its suppliers, customers and other business partners.

Interest in BPM is growing really fast, according to a report from Forrester Research, one-third of organizations surveyed by the firm are currently using or piloting BPM, a

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

dramatic increase compared with mid-2002, when just 11% were trying BPM.
What is Business Process Management (BPM)?
BPM automates and streamlines the business processes which are crucial for the organization in order to improve productivity. From hiring a person to processing a purchase order, BPM helps restructuring, contro

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

ling and handling workflows involving people and systems to complete a process more efficiently.
To use BPM effectively, companies must focus on the outcome of the process and design workflows based on the expected result from the process. There should not be any difference between a task done by computer systems or people. BPM should be able t

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

map the interaction among the entities, objects and tasks and bring them inline with the process workflow. Business rules used in the process also should be clearly defined. While trying to automate a business process you have to keep in mind that finding a process which should be streamlined is not that difficult! Problem occurs when you try to defi

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

e which entities are involved and how the evolved method will distribute the previous roles among the new tasks owners.

The benefits of BPM adoption are enormous:
Direct

Update processes in real time
Reduce overhead expenses
Automate key decisions
Reduce process maintenance cost
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
Reduce operating cost
Improve productivity

Indirect

Improve process cycle time
Improve forecasting
Improve customer service
Improve sourcing time cycle

How to figure out which of the business processes you need to automate?
Companies

dd to the challenges in developing combination products:

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

are using BPM systems to automate virtually every aspect of their businesses. A company for example might have priorities to automate their sales activities, requisition process, procurement process, warehousing, call center, etc. However, the focus initially should be given on those areas that meat the following criteria:

The busines

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

process should be crucial for productivity improvement

Savings from automation is clearly visible

Return on Investment from implementation is high and preferably immediate

Since your business has unique characteristics which differ from others, you might have business processes that have exceptional business rul

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

es. Normally, this type of business processes need maximum attention and substantial resources. Business Process Management tools are great in handling exceptions. Use BPM systems to streamline these processes.

What are BPM Systems?
BPM Systems are applications that help organizations to automate their business processes end

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

o end from a workflow task to process outcome so that they can reduce process costs, improve productivity and bring efficiency to their business.

A successful implementation of BPM systems requires clear understanding of organization’s business processes, business rules, and willingness of the management and workers to embrace new way of d

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing business.

Your Enterprise Portal can be the BPM platform you need

Your company Portal is the access point for your customers, vendors, business partners and staff to company information and services. A typical company Portal is an integrated website of Intranet, Extranet, Repositories, Procurement and Sales Systems, C

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

stomer Relationship Services, etc. Today, advanced Portals are also integrating Business Process Management Systems, which enables automation of workflows that model end-to-end business processes.

In any business process the owners of the process, the users and the objects interact at many levels, such as starting a process, monitoring the

.

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

rocess, doing a task, creating new activity, approving a task, etc. In order to reflect the business processes, their progress and interaction with users and owners, a dashboard is used. You can easily integrate any business process into your company Portal and display needed workflows, notifications, charts, performance indicators as a dashboard on i

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

Companies that provide selfless information through particip

.

Conclusion
Investment in BPM is the same as any other technology related investment. If you plan the project properly, set a clear goal, educate the people those who have to change their mindset once the system is implemented and get necessary support from the management, you can count on a massive return on your investment

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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