Useful Advices - Business

What is document security? Why is document security important to me? What are the best methods my company can use to enhance document security? Is it expensive to do? These are some of the questions you may have about docume

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

nt security.

In this article, I will explain more about document security and why it is important that your business implement some sort of policy or plan to improve the way your employees and you handle documents.

Almost

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

Examples of combination products may in

very business has documents that they have to process on a daily basis. Contracts, Invoices, Receipts, Purchase Orders, In-house Memos, and documents related to sensitive information are some of the examples of documents you

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

may use.

Document security includes how those documents are stored, backed up, processed, delivered, and disposed of. First we will talk about storage and backup of your documents. This involves a lot more than just which t

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

pe of filing cabinet you want to buy.

Even in this electronic age, paper documents are a necessity. The storage of these documents safely and securely is often ignored. For sensitive documents, you do need locked file cabin

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

Combination pro

ts. You need to be aware of who in your company will have keys to those file cabinets and they need to be stored in a secure location. Fireproof filing cabinets are also a good idea.

This might seem to be inconvenient, expe

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

sive, and time-consuming, but the loss of your documents is going to cost you a lot more time and money than having security in place for them.

Transferring all of your documents into electronic format is essential to docum

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

nt security. Either through data entry or through scanning of documents you can back them up in electronic format to help ensure their safety and recovery if you lose all the paper.

Many of your documents today are already

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

n electronic format. Those and the electronic backups of the paper documents you make also need to be backed up besides just on your computer. There are electronic data storage services you can use online that will give you

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

torage space on secure servers.

Some of these can be relatively inexpensive, others charge too much. I suggest you research several of them to find the solution that is right for you. You can burn those documents to CD, but

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

then must find a secure way, off of your business premises to store those CDs.

You can store the data on other computers you have at home or elsewhere, but need to keep in mind who might be able to access them. The companie

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

Following aspects would a

s that provide secure storage for electronic documents and data are usually a much more secure method.

You need to implement a specific security policy in regards to every type of document your company uses. Your employees

dd to the challenges in developing combination products:

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

eed to follow these specific document security guidelines at all times.

Document and data delivery is also an important consideration. Do you use encrypted email when sending and receiving documents? Do you require a receip

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

from the receiver of your emails to show they have gotten the data you sent them? These are easy to implement. PGP for email is one of the best methods. Do a search for PGP and you will find more information about it.

When

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

you mail sensitive documents, do you use registered mail? Do you insure it? These are important pieces to your document security policy. Your employees should know which specific types of outgoing mail are to receive special

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

attention.

Who opens the mail your company receives? Is it ever left out in the open where just anyone can pick it up? Your employees should be aware that document security extends to incoming mail as well. There needs to b

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

Professional from academic institutions, pharmaceutical industries, health care indust

specific instructions as to what happens to all incoming mail.

Now we can move on to document disposal. Do you have an office shredder? You may want to have one in each employee’s work area who might be handling or creatin

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

sensitive company documents. Have a policy of shredding the documents they throw away. Better to be safe than sorry. Thieves and others will go through your trash to find any information they can use to their advantage.

If

.

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

you have a lot of sensitive documents or wish to be more careful, there are services that come to your office to shred and destroy documents then remove them to be incinerated. These companies guarantee the safe disposal of

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

Companies that provide selfless information through particip

your documents.

I hope this article has helped answer any questions you may have had about document security. I further hope that it has made you aware of the need for you to have a document security policy at your business

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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