Main Subject - Business

Key control, or more accurately the lack of key control is one of the biggest risks that businesses face

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

.

What is the risk?

Imagine, you have fired a trusted employee, unknown to you that person had a spare

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

Examples of combination products may in

key to your business, they come back after hours and steal business secrets, account lists, equipment o

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

r anything else of value. Would this scenario hurt your business?

Even if the person turned in all of t

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

e keys they had been given, can you be sure they did not have a duplicate made?

Even worse, a current t

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

Combination pro

rusted employee could be stealing from you.

Your first line of defense – A Key Control or High Security

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

Lock & Key System

Not having a patent controlled key system leads to unauthorized key duplication, whi

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

ch leads to employee theft.

Even keys that are stamped “Do Not Duplicate” are of little assurance. If a

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

l keys were duplicated by only trusted, ethical businesses this might be enough, however almost any depa

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

rtment store, home center, lumberyard, even drug stores duplicate keys. Should you really expect the min

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

imum wage clerk in some of these places to watch out for your security?

Most key control systems utiliz

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

Following aspects would a

e patented keys and or cylinders, because they are patented, the duplication of keys can only be done by

dd to the challenges in developing combination products:

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

factory authorized professional locksmiths.

The key blanks and lock cylinders are made available only t

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

o those same factory authorized professional locksmiths.

The key duplication and/or control can be at t

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

he locksmith dealer level, at the distributor level, or at the manufacturer level.

All high security ke

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

y control systems require specific permission to have keys originated or duplicated. These procedures me

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

Professional from academic institutions, pharmaceutical industries, health care indust

ns there is a record of who had keys made and when, and who authorized it, which in turn assures that th

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

e owner will always know who has keys and how many. If an employee leaves and you get the keys back, you

.

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

can be reasonably assured that no copies of your keys are floating around.

Your Security Professional,

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

Companies that provide selfless information through particip

can help you select the system most suited to your needs. For more information, explore the links below

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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A lot if not most companies, have two support operations, a customer support and a service support operation. Now days most all companies also use an elaborate telephone screening process for the incoming calls. I would like to suggest an alternative way to improve the quality of the support offered to your customers.

Have you ever done business with a business, when they suddenly changed something, but not for the better? Why would they do that? Read this story and consider how you can make certain that your business only makes changes for the better.

Find out if a task force organization is the best choice for your project management needs.

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Main Subject - Key Control - Who Has the Keys to Your Kingdom?

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