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Social Articles - Business Continuity and Disaster Recovery - A Business Not a Technology Issue
Hackers, hurricanes, fires, flooding, power outages, denial of service attacks, application failures, employee error, sabotag
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
e and now terrorism are helping companies to focus on the necessity of a business continuity plan.
Through the late 1990s as
Through the late 1990s as
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
companies prepared for Y2K, many IT executives, risk managers, CFOs and corporate managers realized that recovering computin
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
systems, networks and data was not enough. As Y2K approached, it became more apparent that a disciplined approach was needed
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
to recover not only data and systems, but also business processes, facilities and manpower to restore and maintain critical
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
functions.
The starting point is a risk assessment. Identify and define your mission critical business processes and systems
The starting point is a risk assessment. Identify and define your mission critical business processes and systems
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
Review them for vulnerabilities and identify steps required for restoration and recovery. For your data, make sure it is bac
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
ked up to secure and separate locations. Evaluate various storage solutions including storage area networks, data replication
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
systems, new virtualization systems, network attached storage devices and managed storage. Pay significant attention also to
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
your telecommunications providers to ensure they have built diversity and redundancy into their networks and have well develo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ped and tested contingency plans.
The risk assessment will start to drive out real questions on the business impacts and los
The risk assessment will start to drive out real questions on the business impacts and los
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ses that could result from disruptions. Mission critical impacts, key business functions, processes and records must all be i
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
entified. This is also the time to determine resource requirements and acceptable recovery time frames.
Various recovery str
Various recovery str
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ategies should be evaluated to achieve your cost, reliability and time to recover objectives. Include physical, technological
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
, legal, regulatory and personnel considerations when you evaluate alternatives. Common points of failure are a lack of execu
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
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
ive and budget support and not fully engaging employees. Along with your data, employees are your most valuable asset. An exc
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ellent checklist "Considerations for senior management during a time of crisis" is at y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
m" target="_new">www.globalcontinuity.com (enter checklists in the search box, click on DR & BC checklists).
Business co
Business co
.
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
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
tinuity planning sounds expensive and it can be time-consuming. However, losing your business functions, processes and system
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
s as well as your company, customer and financial data can be devastating. Build your plan. Train, test, train and test again
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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