Digg It - Business

Disaster Recovery is not Business Continuity. Many companies do not have full business continuity plans. They say they do have business continuity plans but they really me

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

an that they have a disaster recovery plan, usually meaning that they have alternative premises and possibly equipment that can be used in the case of a full scale disaster.

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

Examples of combination products may in

Business continuity covers far more than just the IT systems. Think of all the paper records an organisation needs to continue working. Think of the most important asset

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

of all to most organisations: its staff. Without its staff these organisation ceases to exist. A business continuity plan contains information for all staff and their acti

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

vities in the case of problems affecting the organisation.

A preliminary to the testing of any plan is to establish some form of Business Continuity Group consisting of rep

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

Combination pro

esentatives from each of the main business areas, together with those responsible for finance, facilities and IT.

Once a business continuity plan exists it needs to be main

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

tained and tested regularly. Once again, many organisations say their plan is tested but what happens is that they show that the major IT systems can be seen to be working

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

n equipment at a disaster recovery site. Often there is no involvement other than from the IT Group.

It is essential that business continuity testing follows a risk based

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

approach. This provides 2 main advantages. Firstly any business continuity must be aligned to the business and that the plan should be designed to cope with risks to the b

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

siness. Secondly, by following a risk based testing approach to business continuity, this highlights the areas not to test, by prioritising the main risks to business and t

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

herefore identifying areas of negligible or zero risk.

Business continuity testing need not be onerous or expensive. There are a number of ways in which testing can take p

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

Following aspects would a

lace; each is mentioned below.

Business continuity testing can be broken down into 2 main areas, desktop testing and physical testing.

Desktop testing can be a paper walkt

dd to the challenges in developing combination products:

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

rough where a group of people work through the plan looking for areas which require further work. It can also be scenario testing where a group sit and work through a scen

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

ario given to them, such as electrical failure, fire, bomb threat etc. The scenario is defined by a different group of people who then monitor the accuracy of the business

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

ontinuity plan.

Physical testing means a form of business continuity testing that happens outside the conference room. This is broken down into a number of different tests

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

. Firstly a communications test. Can everyone who needs to be notified during a problem actually be contacted? Second in physical testing is a disaster recovery test, whe

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

Professional from academic institutions, pharmaceutical industries, health care indust

e the IT systems are established on a secondary set of computers, and thirdly, a full relocation test, where the business areas relocate to another site. All of these tests

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

are carried out in order to hone the business continuity plan and to provide assurance that it will be effective when required.

In summary, all business continuity plans n

.

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

ed to be tested. Some companies believe that the testing would be too complex, time consuming or expensive. It is therefore essential to use a 3rd party group of experts t

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

Companies that provide selfless information through particip

o advise, help carry out and monitor the tests that are carried out. The 3rd party would also make suggestions regarding any changes believed necessary to the existing plan

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/23717/diggit-Business-Continuity-Testing.html">Business Continuity Testing</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/23717/diggit-Business-Continuity-Testing.html]Business Continuity Testing[/url]

One universal and noteworthy characteristic of human beings is to seek accolades for their accomplishments. From childhood to maturity we are captivated by the lust for recognition in some form or the other especially for remarkable

To become a dentist, an individual must go to a medical college like regular medicine students and specialize in dentistry. Dentistry is the science that deals with the prevention and cure of diseases and ailments related to the teeth and mouth. However, many people who educate themselves in dentistry think that they can only practice as a dentist. However, there is a whole range of opportunities in this field. Dentistry has a variety of jobs within the field and in fact, there is a great demand for these qualified people

Information Quality (IQ) is cause for serious strategic and financial concern. The best course of action, and the most cost effective, is the implementation of a universally applied discipline that fosters intolerance for late, missing and faulty reporting.

Tags

Links

Digg It - Business Continuity Testing

Related Articles: