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Nordural ehf's backup system needed to incorporate a Disaster Recovery plan that would reduce the backup window from te

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

n hours to two-three hours.

A Disaster Recovery Plan is a coordinated activity to enable the recovery of IT/business s

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

Examples of combination products may in

stems due to a disruption. Disaster Recovery can be achieved by restoring IT/business operations at an alternate locati

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

on, recovering IT/business operations using alternate equipment, and/or performing some or all of the affected business

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

processes using manual methods.

It was essential that Nordural's backup system incorporate a trustworthy Disaster Reco

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

Combination pro

very plan that would reduce its backup window from ten hours to two-three hours. In addition to this, Nordural wanted a

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

Disaster Recovery plan that restored the company's most critical servers to bare metal restore in less than two hours.

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

Nordural's decision to select the SecurStore Remote Backup Service highlights the strength and flexibility of managed

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

ervices.

Remote backup (sometimes also referred to as online backup) is a service that provides users with an online s

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

ystem for backing up and storing computer files. Remote backup service providers are companies that provide a software

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

rogram and space on a server that their client's data is stored on. The software program will run on a client’s compute

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

Following aspects would a

and (typically) once a day; compress, encrypt and then send the client's data to the remote backup service providers'

dd to the challenges in developing combination products:

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

servers to be stored.

With SecurStore, Nordural had the assurance that all their requirements would be met - from a fa

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

t critical restore, to remote backup at multiple locations, to a simple and effective interface for the IT people at No

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

rdural.

"We chose the SecurStore Remote Backup Service because it gives us all round backup and recovery services for

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

ur needs, with 24x7x365 support" said Emil Hilmarsson, IT Manager Nordural. SecurStore also provided Nordural with the

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

Professional from academic institutions, pharmaceutical industries, health care indust

option of assigning which data is 'critical; and which is 'important' data by using Long Term Storage with the use of B

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

ckup Lifecycle Management system that manages data during all backing up and archiving processes.

Backup Lifecycle Man

.

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

agement differentiates data into varying levels of protected data: current critical data, which is stored on-line for f

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

Companies that provide selfless information through particip

st recovery; and archivable data that may be needed at a later time but is not likely to be accessed in the near future

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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