Advice You - Business

Many business owners think the epitome of a smooth operating office is a paperless one. They want to throw away their file cabinets and storage facilities in favor of keeping everything on

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

computer disks. While this sounds like a wonderful way to run a business, you have to decide if going paperless is right for your company?

Going paperless is a big step for any company a

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

Examples of combination products may in

d requires a lot of planning before you start. One of the most important things to remember is when you go paperless you must backup your files regularly. Daily backups should be done, wit

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

out fail, to insure your records are safe. Not only should you have a backup on-site, but you should also keep a copy off-site. You do not want a fire or other disaster that destroys your

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

uilding to ruin your records as well.

Before you make the decision to go paperless, you will need to consider some things first.

A paperless office will not happen overnight. Unli

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

Combination pro

e changing the type of copier you use; changing your office dynamics to a paperless one is not as easy. You have to plan carefully. You will need to purchase the proper equipment, such as

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

canners and backup systems, to facilitate your change. You will need to train your employees in using this equipment. In the beginning you will have more work until your new system is runn

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

ing smooth.

Decide how much past information you want in your computer backups. Depending on the type of business you have, you might be able to go back to the beginning and scan i

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

all your old invoices, payment records, etc into the computer. Small businesses are better able to do this since their records are not as abundant as a larger corporation. It is really up

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

to you how far back you go, but make the decision prior to starting the transition, so the change easier to manage. Also, take state and federal record keeping rules into consideration whe

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

you make this decision.

All of your employees must be willing to make the change. It will only make your decision to go paperless more difficult if only a percentage of your emplo

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

Following aspects would a

ees are willing to make the changes required. Everyone must do their part to make this change happen. You probably will have some employees who are change-resistant. Those are the employee

dd to the challenges in developing combination products:

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

you will have to work the hardest to convert. You must be firm that this is the company's new policy and you expect all employees to follow it.

Your office will not be totally paperle

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

s. You are going to have customers and vendors who will not deal with electronic transactions. Do not throw out your old forms. You can use them for those few hard-copies you will have

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

to print out. Also, some government offices, both state and federal, require keeping a paper hard-copy of certain records. Double check your local, state and federal requirements for proo

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

of your business records. But even if you have to keep some hard copies of your records, the amount of paper stored will be minimal in comparison to what you were keeping.

Rearrange y

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

Professional from academic institutions, pharmaceutical industries, health care indust

ur office. Once you have the system in place, you will find you need less storage space. As you scan documents into your computer, you can start disposing of the paper versions, thus f

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

eeing up not only file cabinet space but floor space. Getting rid of those space stealers will make your office appear less messy and more professional to your customers and employees.

In

.

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

the end, going paperless does more than help the environment. It can help your business environment by having your paperwork at the push of a button instead of the opening of a file cabine

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

Companies that provide selfless information through particip

. It will give you this access anywhere you have internet access. You will spend less time shuffling paper, less time trying to find something important and more time building your busines

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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Advice You - Are You Ready for a Paperless Office?

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