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An accounting system is a process whereby a specific output is produced by a given input. In an information accounting system, data is processed to p

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

rovide information. Data is a collection of unprocessed facts, while information is data or facts that have been processed into a meaningful form.

I

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

Examples of combination products may in

n the normal course of events, a business undertaking will enter into a large variety of transactions. The details of a particular transaction are re

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

erred to as transaction data. The term transaction data therefore refers to the facts that completely describe a specific transaction.

The aim of an

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

accounting system is to record the transaction data and then to process this data to provide information that is ultimately collected in the financia

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

Combination pro

and management reports of the enterprise. There are two stages in the development of an accounting system, namely systems analysis and system design

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

.

A good accounting system must comply with at least the following fundamental requirements. The system must provide decision makers with timely and

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

accurate information relevant to the responsibilities and requirements; the internal control measures must be adequate to ensure the protection of as

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

ets and the provision of reliable information and the system must be sufficiently flexible to accommodate changes in the volume of activities and in 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

he operating procedures without requiring drastic modifications.

A thorough knowledge of the activities of the undertaking and its information and co

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

trol requirements is an essential prerequisite for the development of an effective accounting system that meets the necessary criteria. The procedure

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

Following aspects would a

of surveying the undertaking's activities and information and control requirements is known as system analysis.

In the system's design process the s

dd to the challenges in developing combination products:

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

ystem is designed to comply with the specifications determined by systems analysis. Initial transactions are recorded in source documents and the in

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

ournals and finally they are classified and stored in ledger accounts. The processed information is extracted from the ledger accounts for drawing up

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

the financial reports. The design of any accounting system within this framework comprises of, planning the procedures according to which the system

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

will function, the design of the source documents, journals, ledger accounts and final reports and finally the design of the necessary internal contro

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

Professional from academic institutions, pharmaceutical industries, health care indust

l measures.

From a management information point of view it is important that the information needs of a user are determined and that the accounting r

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

eport meets these needs. Rapid development in the field of computer accounting has led to the effectiveness of the accounting process, enabling more

.

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

sable, more accurate and more timely output of accounting data. Efficiency increases as the value of the system increases in relation to the cost the

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

Companies that provide selfless information through particip

reof. Computerised systems have made the accountants job in designing the accounting process that much easier than the manual systems of days gone by

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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