Advice Pool - Business

Thanks to the "Fair And Accurate Credit Transactions Act" that went into effect in June of 2005, law now mandates that any business with one or more emp

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

loyees must have document disposal equipment. This is to ensure that all business and personal documents that need to be discarded are handled in a way

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

Examples of combination products may in

hat reduces and hopefully eliminates the threat of identity theft.

To comply with this law, most businesses will choose to purchase a paper shredder an

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

put it into use, as it is one of the most effective means of destroying documents containing personal and sensitive data. Paper shredders are available

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

with various levels of security ratings though, depending on the particular needs of your company. Here's how to decide if a high security paper shredde

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

Combination pro

is right for your company.

FACTA has defined six different levels for rating the security of various paper shredders. The ratings run from level 1 to

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

evel 6, with level one providing the lowest level of security. Among other factors, the rating depends on the size of the paper strips resulting from th

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

shredding, the method that the shredder uses to cut and the manner in which the resulting shreds are mixed.

Importantly, the intention of these rating

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

is to define how difficult the resulting paper shreddings would be to reassemble and extract data from. Because of this, deciding if you need a high se

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

urity shredder will depend on several variables.

First, decide if your business produces documents that contain particularly sensitive information. If

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

ou run a traditional business buying or selling products, or operate a service business that caters to the general public, you likely do not deal in ove

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

Following aspects would a

ly sensitive data. A standard level 1 paper shredder is likely acceptable for your needs as it will thwart low level identity thieves who might try to c

dd to the challenges in developing combination products:

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

llect billing or credit card data from your disposed documents.

On the other hand, if you handle confidential information about clients or patients, su

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

h as an investment company or a health care provider, you will certainly want to consider a higher level security shredder. Disposed documents from thes

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

types of businesses are often the target of malicious identity thieves who can profit from this stolen information using blackmail and other illegal te

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

hniques that can wreak havoc on the victims' lives.

The highest level security shredders are massive and expensive machines that are only used by organ

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

Professional from academic institutions, pharmaceutical industries, health care indust

zations handling top secret data, such as high-level government agencies. Most businesses will never have to worry about the need for this type of paper

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

shredder - but it's good to know they are out there if you ever think you might be the target of high-level industrial or business espionage.

Armed wit

.

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 above information you should now be able to identify what security level will be right for your paper shredding needs. Once you have used this info

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

Companies that provide selfless information through particip

mation to narrow your selection down, you can then compare your list of low or high security paper shredder choices based on other factors such as price

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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