Advice You - Business

Business document management historically has been - and in many quarters remains - a tedious process involving ranks of file cabinets, platoons of file clerks, hours 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

nd hours spent placing specialized paper business documents in storage and often, still more hours researching their whereabouts and recovering them when they are neede

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

Examples of combination products may in

.

Recent research indicates the magnitude of the challenge and cost:

90% of typical office tasks revolve around paper gathering and distribut

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

15%of all paper handled is lost.

30% of knowledge workers' time is spent trying to find lost documents.

Companies spend an average of $25,

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

00 to fill a typical four-drawer file cabinet; $2,000 to maintain it each year

Over the course of its life, a single piece of paper costs an average of $30

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

Combination pro

Documents and records are fundamental to virtually every internal, external, legal and regulatory phase of commerce. Burdensome even in small companies and poten

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

ially overwhelming in large enterprises, business document management using paper-based processes represent a huge efficiency/workflow bottleneck.

In fact, relatively

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

ew people gave the situation much thought until it was discovered that by substituting electronic documents for paper documents an organization could eliminate file cab

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

nets and productivity deploy inventory and clerical personnel.

Moreover, electronic business documents -- invoices, purchase orders, production control orders, shippin

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

documents and personnel forms, for example - could be stored easily and conveniently, and summoned as needed right from the desktop.

The importance of business docume

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

ts to the survival of organizations is often overlooked until they are gone. Unforeseen threats to organizations reveal the risks of maintaining records in a paper form

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

Following aspects would a

at, a point dramatically illustrated by hurricane Katrina. Many organizations, including physician's offices, law offices, schools, even courthouses lost most of their

dd to the challenges in developing combination products:

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

aper records and have been unable to recover. Had these organizations implemented an electronic document management system, recovery could have been much more attainabl

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

. When documents are stored in an electronic format, it is a straightforward process to back up to offsite locations. This greatly simplifies data recovery in the event

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

of a natural disaster.

While once considered to be an issue limited to big business, complying with regulations, such as Sarbanes Oxley and others, increasingly requir

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

organizations of all sizes to keep tract of all financial information including copies of documents related to financial transactions. The use of paper documents makes

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

Professional from academic institutions, pharmaceutical industries, health care indust

it difficult to comply with these regulations. Retrieving copies of documents related to particular business transactions is extremely time-consuming. Moreover, it is d

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

fficult to demonstrate control over the use and access to those documents when they are in paper format.

The pay-off in making the switch from paper-based business doc

.

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

ments to electronic business documents is immediate and significant. By using a document management solution, organizations benefit from improved efficiencies and cost

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

Companies that provide selfless information through particip

avings when producing, distributing, and storing documents, better customer service, faster collections, as well as enhanced regulatory compliance and disaster recovery

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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