Top Adding - Business

Introduction to Document Management

If you've never used a document management system, then it is entirely possible that you aren't aware of how valuable these products can be. Companies and individuals who manage a diverse array

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

of documents have found that document management systems serve to simplify their lives and make both storing documents and later obtaining those documents much easier.

Many companies are forced to go the way of electronic document

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

Examples of combination products may in

s because of The Sarbanes Oxley Act of 2002, industry compliance (HIPPA), or because it is required by their customers or vendors. The simplest form of electronic document management is storing files in an organized directory and c

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

tegorizing files by the folder in which they are located. If your company manages more than a few documents, this method can quickly become very inflexible. Incorrect filing can cause a document to disappear into a virtual black ho

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

le, never to be seen again.

The entire process of document management can be broken down into four categories: file capture, file processing, file management and file storage. A company may require one, two or all four of these pr

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

Combination pro

cesses. File capture was covered in part one of this article.

File Processing

File processing can help make files more manageable. Examples of processing tasks include: separating and merging, OCR; zonal OCR; forms recognition; c

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

onversion; routing; and database (DMS) population. Some of the processing tasks can be completed with scanning software and/or your DMS. Files can be processed years after they are scanned or during the scanning process.

OCR (opti

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

cal character recognition) allows scanned documents to undergo content text searching once the document is added into your system. Word, Excel, and other digital files do not have to undergo the OCR process to be content-searchabl

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

. Indexing the documents makes the content search very fast, even if you are searching through thousands of files.

Recent improvements in OCR make the process very accurate (up to 99%), however the accuracy of the OCR is dependant

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

on the quality of the document and to some extent the hardware used to scan the documents. Most companies are happy to enjoy the benefits of OCR and content text search even with its imperfections.

Zonal OCR (OCR of a specific z

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

ne on a page) Scanned documents can also be processed to find certain information on the document and input it into fields in your document management system. For example, an invoice number may be required to organize and store the

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

Following aspects would a

document so that the invoice number location is predetermined in a template and then that number is read and input into the document management system. This process is called "forms recognition," and may include many fields of inf

dd to the challenges in developing combination products:

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

ormation from a single document. Depending on the type of documents and the quantity of fields to be populated, this process and be both complex and expensive, so it is important to weigh the cost with the benefits.

File Managemen

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

There are many different types of applications available on the market with which to manage files. Choosing the one that is right for you can be complicated, and sometimes requires a consultant. Companies that choose to create th

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

eir own systems are recreating the wheel and will be forced to replace that system at some point in the future. Some critical issues to consider when choosing the system that is right for you are:
1. Types of documents you a

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

e managing (working vs. final)
2. Internal and External Requirements
3. Browser or Desktop Interface
4. Cost of Ownership

Final vs. Working Documents

A final document, such as a contract or an invoice, ma

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

Professional from academic institutions, pharmaceutical industries, health care indust

y not need to be edited at a later date. It is saved for reference and/or retrieval purposes, and will not necessarily be needed again. These are called "final documents". Managing final documents is much cheaper and easier than st

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

oring documents that require editing capabilities. If you simply want to scan final documents and store them for later retrieval, you may only require a simple and inexpensive DMS.

A working document, on the other hand, will need

.

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

o be revised on one or more occasions. These types of files might include manuals, sales literature, or CAD files. The author or other colleagues may need to edit them, or they may need distribution for specific purposes. A more ad

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

Companies that provide selfless information through particip

vanced and versatile document management system will be needed so that the user can track changes, implement markups and revise text.

File Storage

File storage is covered in a proceeding article titled: EDMS – File Storage Option

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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