Main Subject - Business

Electronic mail has revolutionised business communication, while computerisation in general has defined a new era in the management of information.

With the electronic mail revolution and with computerisation in general, business communications have unde

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

rgone massive changes in recent years. Traditional corporate communication methods such as mail, couriers, faxes, and even telephones have been downgraded in terms of importance for day-to-day business communications.

But with the changes have come some

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

Examples of combination products may in

resh challenges. Two in particular are at the top of the list of headaches for most organisations. Firstly, the problem of email overload, and how to file and allocate all the attached documentation which accrues. And secondly, the continuing need to man

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

ge electronic documents thus generated, and the more tradition paper-based documents which are still part of the business workflow.

Workflow problems: an example

To solve the first problem, many software systems have been developed for

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

mail management. However, these do not necessarily solve the second problem, and at the same time, they miss the opportunity to attack both issues with one overall software solution. Consider this example situation. An invoice arrives in the regular mail

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

Combination pro

nd is filed by the bought ledger department. At the same time, a confirmation email arrives to the purchase initiator stating that the invoice has been sent. This gets copied to the accounts department via internal network. The accounts department can res

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

ond to this to acknowledge receipt, but crucially this is not electronically linked to the details of the invoice. Thus later, if a query arises, an email management system will be able to retrieve the email, but the invoice will take more hunting through

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

other files. Thus time and money is unnecessarily wasted on searching for related information stored in different ways and formats.

Electronic Document Management solutions

For many businesses the solution is to be found in using elec

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

ronic document management (EDM). EDM is a high-level storage system which collects, indexes and stores information in all forms - including email of course - and which consequently can be easily searched and audited by every staff member to whom it is rel

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

vant. An integrated, organised electronic document management system ensures a business is storing and protecting the important information and knowledge that make up the intellectual and intangible assets of the company. Additionally and crucially, it en

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

ures a company meets its legal requirements for the storing and retrieving information which in some cases is a need that goes on for many years.

Things to look for in an EDM system

The best advice to begin with, is to ensure the EDM sy

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

Following aspects would a

tem can manage all types of document, not only email. This would include paper documents and well as electronic formats, for example faxes diary records and written reports. Also, of course, video and audio formats are often part of a company's knowledge

dd to the challenges in developing combination products:

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

ase, and should be included.

The system should also be able to allow editing and modification (password protected) of documents from within the system. Originators of documents might be using their own particular front-end application, but where the docu

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

ent produced is shared, it should be editable via the EDM.

The system should allow access to records according to a managed set of rules and guidelines to be set up in the EDM system, with a corresponding audit trail to ensure security and accountability

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

at all times.

How does EDM work?

They work by scanning documents into a system where they are automatically indexed and filed electronically, so documents can then be instantly recalled by searching on key words. The systems can work i

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

tandem existing software such as accountancy packages and contact databases, so that output from several different systems may be electronically filed within the one overall meta-system.

How to choose an electronic document management system
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ong>

One of the first things to look for is an electronic document management system that is very easy to use. It should be easy to install across a network, and be up and running within days. Pay attention to the user interface - the best systems have
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
nvested hugely in these, to ensure that staff will require minimal training to use the system. Remote access to documents should also be explored - finding documents while on the move should be straightforward.

Finally - the benefits

Th
.

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
man benefits to an EDM installation is improved productivity, better teamwork and work relations. Staff will become used to sharing knowledge and documents to the benefit of all. Less paper in the office makes environmental sense, with no space-consuming
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
hard copies to find room for. In short, all data becomes instantly available at the touch of a button, offering peace of mind that company procedures can be followed in detail, and response to regulatory checks can be actioned the moment they are required

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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Main Subject - Electronic Document Management (EDM) - Steps Towards Better Workflow

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