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1. What you should be doing about data backup and why?
2. Fine electro-mechanical devices to backup.
3. Meant to do it!
4. Once Bitten.
5. Backup, a mistaken or confused name.
6. What do you need to do today to start a backup plan or backup program?
7. Let’s get organised.
8. Things to save or to backup.
9. Our recommended Backup System.
10. Near wors

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

t case scenario. When you most need a backup to restore from.
11. Our own system. How we backup our data.
12. Remember, Backup, start today.

1. Why do a data backup? What you should be doing and why? Computers always go perfectly. Right? What would you do without your PC? Computers can and do fail usually at the worst possible time. They may get stolen, trashed or

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

Examples of combination products may in

crash. Most of us deal with the problems as and when they occur. There are times though, when a little bit of planning and forethought pays big dividends.

2. Fine electro-mechanical devices. The hard drive in your computer has both electronic and mechanical components that work with very fine tolerances where the head literally flies a fraction of a millimeter above the disks fast spin

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

ning surface. Measurements a fraction of a human hair thickness are not unusual. So bumping or dropping them or having PC power problems causes the components to literally crash and may result in irreparable damage.

3. Meant to do it! Most business people and many home users are aware of the need to Backup (or copy, in easy terms) their information to another place for safe keeping. Aft

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

r failures they often say ‘I meant to do it but never made the time.’

4. Once Bitten. Every day before they walk out of the office they’ll religiously run or at least start the backup going. In the morning they’ll check and make sure all went Ok with the Backup and look at any errors reported.

5. Backup, a mistaken or confused name! Simply put, Data Backup is the ability to rec

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

Combination pro

reate or restore the system you had working before the PC failure or loss. It may be called Copy, Save, Burn, Write. Unfortunately the word Backup is often used different ways. And means different things in different places! Bookkeeping software typically prompts you to backup your data (the company accounts and ledgers, in other words). But the backup is usually on the PC not another disk or

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

computer. So if that computer goes missing, then the company bookkeeping info is gone too. You need to do this type of data Backup for bookkeeping and company client lists. But there’s more to do. Make a note where it goes to so you can Backup or copy it to another disk, CD, ZIP or Flash device you can take home.

6. What do you need to do today? Simple. Work out what you use your com

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

puters for that you simply couldn’t do without if it wasn’t there tomorrow. Would your business or personal relationships STOP without the ability to re-create the computer info you’re using? Please. Take a minute to read the full story below.

7. Let’s get organised. You’ll need: - any equipment and software to make the backup; a plan to follow to do it regularly; to backup what

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

you should; to store it somewhere safe; to write down the backups done; reminders to do it next time; most of all the patience to wait and do it whenever it’s due. Lastly, it should be tested that you can recover from disaster if it ever occurs.

8. Things to save. Information to Backup should include Documents; Spreadsheets; Bookkeeping & Transaction data; Address Books; List

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

s; Emails; Personal information, Photos; Downloaded Programs and Licenses; Favorites; Special things; Internet & Email settings; Regulatory matters. Many of these items are irreplaceable, so they should be safeguarded.

9. Our recommended backup system. Two copies, one at your place and one at a friends place. Small Backup, things that change frequently, done daily. Big Backup, tot

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

al Backup of your PC because the info is organised in a disorganized sort of way, spread over the hard drive in hard to find places, done weekly or monthly. More than one PC? If you have more than one PC you may need to re-think and re-organise where information is stored in the computers. A central point for all company data is easier to manage and Backup than data in all the odd places o

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

Following aspects would a

n the computer. You may investigate ‘synchronizing’ data so it’s naturally on more than one PC.

10. Near worst case scenario. If the Hard drive fails the information may be recoverable. But it’s a very expensive job by the professionals. Occasionally one of our customers has needed to retrieve data from a dead hard drive. We recommend a particular company who has always managed to r

dd to the challenges in developing combination products:

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

cover the data, but there’s a lot of lost time and un-necessary expense especially when compared to the simple smart solution where you take all the necessary precautions and do the backup first.

We hope you never see one of these errors:- an MYOB fatal error 1199 as one of our customers did recently. It translates to the data file causing this error is definitely unusable and irrepairable. I

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

t can only be fixed by restoring your data from your most recent backup. (Do you have a recent Backup?) or HAL.DLL is missing or corrupt. It translated (in this case) to the Windows folder has disappeared. Anything at all that was stored in the windows folder is GONE. Windows needs to be re-installed from the original media (CD), Updated and Settings restored from a recent backup. Occasionally

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

we (you or I) will start working on a document or data file and have a little accident. Accidents happen to us all occasionally. The simplest way is often to simply restore from the most recent backup, or waste a lot of productive time just getting things back to the way before we commenced, and made the accident. Just imagine what the worst case would be!

11. Our own system. How we backup

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

. Pixel ITT has these systems in place. Daily, MYOB, when closing company data the data integrity is checked and Zipped up on the C Drive. It takes about 3 minutes.

Monday, 9am, Customer database and documents, Zipped into one file on C Drive. Takes 5 to 10 minutes at the start of day.

Monday to Friday, 9.50pm, Automatic Backup using XXCopy Pro of My Documents Folder which includes, MYO

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

Professional from academic institutions, pharmaceutical industries, health care indust

, Customer data, Documents, saved to a redundant (older) PC as a file server, 5 minutes unattended. Older PC must be turned on and available on the office network.

Monday to Friday, 10pm, Automatic Unattended Backup of daily data important to business, MYOB, Customer data, Documents, Security info saved to CD, 3 to 5 minutes usually unattended.

Every 2nd Saturday, 2 secondary PC’s, Full increm

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

ental backup, to CD on main PC. Takes 10 to 20 minutes attended.

Every 4th Saturday, Main PC, Full incremental backup to CD on main PC, takes 60 to 120 minutes attended.

What’s missing in our backup system? Off-site backup copy could be more recent but has the main ingredients of our business in a workable version. Backup test has been performed to restore secondary PC’s only. The main PC

.

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

will be done when time permits or it becomes necessary.

12. Remember, Backup, start today. We tell our customers, whether they're small business clients or home computer users at every chance we get, to backup, somehow, but backup regardless. We've all got cd burners and cd writing software these days, but still most clients do not have a recent data backup or use the backup software th

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

Companies that provide selfless information through particip

at came with their computer. If the worst disaster happens, we're called in to clean up the situation and regretfully tell the customer if they didn't backup before the computer was stolen or broken there's really nothing we can do to ease their pain whether it's business critical data or data like home pictures and email address contact lists.

So BACKUP, Backup, backup just do a BACKUP.

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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