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There has been quite a difficulty in explaining and elaborating configuration management for reason of its technicality that many non-technical personnel

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

and even some neophyte in configuration management technology fail to comprehend. Configuration management has therefore been considered by many as the “h

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

Examples of combination products may in

oly grail” of software and information technology. While there can be limitations in defining the concrete meaning of configuration management, it can wel

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

be described and explained according to its goals and purposes.

Configuration management makes it easier for computer systems to evolve with the changes

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

in software and computer technology. The ever growing and the increasing complexity of information technology require upgrades to many computer systems a

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

Combination pro

nd networks. The problem with configuring computer system to newer versions, however, is that it sometimes results in error and damages to the system. Con

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

iguration management technology prevents the occurrence of such problem by recording the details of changes that are done to the components and devices of

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

a computer system. This way, it would be a lot easier to track changes and more importantly errors that could have resulted in network downtime and outag

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

es. In addition to this, configuration management maintains the integrity of the whole computer system by assuring that all changes and configurations tha

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

have been deployed are appropriate for all components in the system.

Configuration management makes it less risky and less difficult to configure comput

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

er systems. While change and configuration are required to catch up with the evolving needs and demands in information technology, configuration can be qu

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

Following aspects would a

ite risky. Systems and even security solutions such as firewalls tend to be more hazardous when misconfigurations occur. Configuration management makes it

dd to the challenges in developing combination products:

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

less difficult to change configurations and set ups of computer systems by providing a fall back option when a new configuration version or upgrade backfi

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

res. Configuration management softwares do this by enabling the computer system to turn back to a previously good configuration set up when new configurat

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

ion versions fail. This will not only reduce configuration risks but will also minimize network downtimes that can result in costly losses among organizat

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

ons.

Configuration management enhances the security features of a computer network. With a configuration management software in place, all processes, con

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

Professional from academic institutions, pharmaceutical industries, health care indust

figurations and changes that take place in a computer system or network can be easily tracked. This greatly reduces the vulnerabilities of a computer syst

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

em from non-authorized intrusions that can come from internal and external sources.

While the concept of configuration management is difficult to grasp,

.

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

t can well be understood by the purpose and goals of configuration management technology. Configuration management makes it easier for computer systems to

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

Companies that provide selfless information through particip

evolve with the changes in technology. It also makes it less risky to configure computer systems and enhances the security features of a computer network

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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