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Why Should I Use Electronic Signatures?

This is a rational question with rational answers, but not everyone has the time or the tenacity to sit down and read the Electronic Signatures I

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

n Global and National Commerce Act (“ESIGN”), Uniform Electronic Transactions Act (“UETA”) or the stacks of other regulations and guidance that make this technology not only legal, but also stress the vital im

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

Examples of combination products may in

ortance of adopting electronic signature technologies.

Today the average American office worker consumes (12,000) pieces of paper a year, with an average annual printing expense per employee ranging fro

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

m $600-$2000. Storing paper and retrieving stored paper is also quite costly. The U.S. government estimates that (1 Lbs) of paper costs ($19) a year to store and manage. At that rate, assuming your business s

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

ores only 60% of the paper printed by your employees, your business is spending $1,500 annually per employee on paper storage alone.

There are obvious other costs associated with paper, for example the

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

Combination pro

osts associated with faxing, shipping, receiving and time factors such as waiting for a job to finish printing or waiting on a package to arrive. In the end all businesses feel these costs, but most look at it

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

as a fixed cost of doing business. In reality this is a variable cost of doing business based on old fashioned processes, and the United States government along with virtually every other developed country ha

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

passed legislation and regulations encouraging businesses to change the way they do business today, and take advantage of new legal and secure alternatives.

All businesses are looking for a competitive

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

edge, and electronic signature technologies can and will play a vital role in helping businesses find and achieve this competitive edge. Look at the simple cost savings your business can achieve by eliminatin

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

some of the hard and soft costs mentioned above. (1) Gigabyte (“GB”) of hard drive space costs ($.50), and this (1) GB of storage will store (100,000) pages of single spaced text. This is the equivalent of ($

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

9,000) of storage savings, ($11,000) of printing savings, and countless savings on time and miscellaneous expenses. Using electronic signature technologies will allow your business to send the previously print

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

Following aspects would a

ed materials securely and immediately to anyone anywhere in the world. Once they receive the file the recipient can legally electronically sign the file, which allows your business to act immediately, and neve

dd to the challenges in developing combination products:

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

wait for a package to arrive from the client or prospect again.

This simple process will have wide ranging effects on your business, and the businesses you work with. Sales and production cycles will b

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

e shortened, employees will be more efficient, and complying with strict federal and state guidelines will become increasingly easier as your business processes move toward electronic communications and storag

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

.

In the end the decision is not whether to move to an electronic format, but which format is right for your business. Some may feel that electronic signatures are too expensive or complex to implement

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

nto their business, but this is no longer the case. There are several pay-as-you-go services on the market today that will allow you to send files and capture secure and legal electronic signatures regardless

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

Professional from academic institutions, pharmaceutical industries, health care indust

of your budget. For larger corporations these pay-as-you-go services offer fast, affordable convenience, and in many cases these services offer better options and are easier to use than large and complex in-ho

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

se solutions.

You can do a Google or Yahoo search to find a list of electronic signature service providers, and determine which one is right for you. There is also a helpful competition analysis put tog

.

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

ether by PrivaSign.com, which you can review at http://privasign.com/esign-competition-analysis.asp. Have fun and explore all of

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

Companies that provide selfless information through particip

our options. The goal should be to become more efficient, and during this process your business will certainly save money, become more productive and save time.
By:
Jason McKay

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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