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Companies must account and deal for new legislation governing how information is stored on IT systems.

The EU is shortly to adopt many of the recommendations on corporate governance set out by the Sarba

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

nes-Oxley Act in the US, UK firms are to be expected to deal with and manage explicit guidelines on how to store email and other documents on their IT systems. IT managers should consider the necessary

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

Examples of combination products may in

rocedures and technologies needed for compliance now, in order ensure technology is able to deal with the new legislation.

Regulations regarding data storage at the moment are fairly lax, but there will

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 a huge increase in the amount of data than must be held over the next 18 months to two years.

Email archiving, the increased use of expensive write-once read-many media, information lifecycle managem

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

nt and content-aware storage as a few of the technologies which firms should consider for the future, though in some cases companies will simply need to improve the way they manage existing systems.

It

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

Combination pro

is anticipated that new legislations will demand that an organizations’ archiving solutions must guarantee that the information they hold has not been changed, and keep it for a specific period of time b

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

fore automatically deleting it.

A survey of 493 companies in the UK has shown that compliance with regulations has a high or fairly significant impact on the data storage strategies of 87% of the organi

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

ations surveyed. Back-up and recovery was also very important to the data protection strategy of 93% of organisations.

78% of organisations future storage strategy is set to include Disk-to-Disk-to-Tape

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

technology. This may be due to the highly affordable and flexible nature of this new technology. For example, recent deployments of disk-to-disk-to-tape (D2D2T) solutions by various companies have, on av

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

erage, reduced the backup window by more than 70%, from fifteen hours to less than four, yielding significant time and cost savings in tape management.

Interestingly, product features were far more impo

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

tant than the brand of the product, with 82% of organisations making a decision based on product features. When it came to the decision of choosing a specialist storage supplier or a general IT provider

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

Following aspects would a

or storage solutions there was a very slight preference for specialised storage suppliers (51%) over general IT providers (49%).

This survey shows that compliance with regulations is a key driver in com

dd to the challenges in developing combination products:

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

anies' storage security policy and that we are likely to see more companies deploying Disk to Disk to Tape technology in the future. All the above is fine if you are a corporate, you have an annual IT b

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

udget of ?500,000 and numerous members of staff who can plan and complete such a system. Is it very easy to talk about SANs, NAS’s Virtual Tape Libraries. Organisations of this nature already have a ve

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

y stable and flexible infrastructure, where it is comparably easier to implement such a system. What about the 1000’s of smaller companies such as solicitors, accountants, medical practices and manufact

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

res etc, which may have only 2 servers on site, but still have the same reliance on data and have to adhere to the same legislations? Backup to tape is an option, however, there is an upfront cost and a

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

Professional from academic institutions, pharmaceutical industries, health care indust

requirement for a trusted member of staff to take the tapes off site every night and store in a safe place. Can you guarantee your backup has worked, and do you really trust your long term data on magne

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

tic media? Another option is to archive your data onto optical devices, however the cost is even more prohibitive than tape and you still need to take the disk offsite.

No doubt your data is growing qu

.

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

ckly; recently enforced legislations makes sure of this, so why not employ a backup and archival solution which has no upfront cost, is fully automated, secure and regardless of disaster will ensure your

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

Companies that provide selfless information through particip

data is always available, Offsite Backup. For further information how offsite backup can help your company, please visit www.perfectbackup.co.uk

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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