Actual - Computers and Technology

A Scenario of What Could Happen

Just imagine this scenario. You own a highly profitable specialty retail store that stock thousands of parts. These parts are procured from the best sources that you have identified over many years,

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

based on product quality, timely deliveries, reasonable prices and customer support. You have also fixed the re-order levels based on years of experience. These re-order levels are the basis for automatically triggering replenishment req

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

Examples of combination products may in

ests when the stock of a part reaches danger levels.

All the data, parts specifications, selling prices, supplier details, inventory accounts, re-order levels, consumption statistics, negotiated prices and other such critical information

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

are stored in your computer system at the back office. You do back up these data onto magnetic tapes. However you have never checked the reliability of these backup tapes.

One day, during a severe thunderstorm, your computer disks become

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

unreadable. And you find that the backup tapes have become unreliable with the restored data being no better than useless garbage.

Now imagine the disastrous impact such data loss could have on your business operations and profitability.

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

Combination pro

You might be able to reconstruct the part specifications and selling prices from paper records. However, re-identifying the preferred suppliers, the replenishment stock levels and negotiated prices for each of the thousands of parts migh

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

prove a highly disruptive exercise, if at all possible. The result would be a serious loss of control over your business operations and profitability.

Now suppose that you had called an expert data recovery specialist immediately upo

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

the occurrence of the data loss. It is quite likely that the specialist would be able to make a complete recovery of the data.

To make such recovery possible, you should not even try to recover the data using the backup tapes that h

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

d never been checked for their reliability. If you do that, the data in the computer might become completely unrecoverable.

How Do Data Get Lost?

Data loss could occur owing to:

Physical damage to the storage device as w

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

hen the hard disk head crashes or other mechanical failure happens

Logical damage to the file system causing incomplete writing and consequent inability of the operating system to display results correctly

Human error

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

r action that results in deleting the data on the storage device

Virus attacks

No or poor backup policies or their improper implementation of the policies

Natural disasters like fires and floods

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

Following aspects would a

How Can You Prevent Data Loss?

There are certain steps that you can take to prevent or at least minimize data loss:

Implement a systematic backup procedure so that the data can be recovered if it is lost. Backup policies and

dd to the challenges in developing combination products:

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

implementation is a complex topic and it is best you get professional assistance for formulating policies and implementing them in your particular situation

Audit your data back up practices and periodically check the reliabilit

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

y of the backups

Train your computer personnel in certain important operational matters. For example, if unusual sounds are heard from the drives, it is best to shut down the computer; don’t get liquids and stuff get into the co

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

puter; unplug power chords if smoke is seen coming out of the computer; and so on.

Install Anti Virus and Security software to prevent virus attacks.

Consider online back up services offered by third parties, which cou

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

d help you even in cases of data loss owing to natural disasters.

In Case of Data Loss, Call in Experts!

Experienced experts would know what to look for, how to proceed and the most suitable alternatives for each situat

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

Professional from academic institutions, pharmaceutical industries, health care indust

on. Your best bet is to entrust data recovery to such a specialist rather than try a Do It Yourself recovery attempt.

You would be able to appreciate advise against DIY better if you are aware of certain facts:

Data storage devi

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

ces pack more and more data in less and less space. Even minute specks of dust could affect the integrity of the data.

Opening the sealed drives could cause just that – allowing plenty of dust to damage the drive image, and make

.

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

reliable recovery of the data impossible. Data recovery specialists work in highly controlled “Clean Rooms” to prevent this.

Data recovery specialists use such methods as replacing the PCB of the drive with a matching healthy on

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

Companies that provide selfless information through particip

and/or replacing read/write assembly parts with matching ones. Not only do these require highly specialized expertise but also facilities for working at high precision levels. End users of computers are not likely to have these.

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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