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Digg It - Electronic Document Management - The Basics - Part 1
Document management can mean many things to many people, and can serve a variety of purposes. The intention of this article is to list the components involved in document management and to briefly describe each one. At the conclusi
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
on, there are also some important factors to help in selecting a document management system.
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
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
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
be. Companies and individuals who manage a diverse array 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. n caus
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
a document to disappear into a virtual black hole, 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 comp
The entire process of document management can be broken down into four categories: file capture, file processing, file management and file storage. A comp
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
any may require one, two or all four of these processes.
File Capture
File capture may consist of scanning paper documents, capturing existing electronic files (ex: .doc, .pdf, .tif and scanned documents), and capturing documents
File Capture
File capture may consist of scanning paper documents, capturing existing electronic files (ex: .doc, .pdf, .tif and scanned documents), and capturing documents
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
from applications with print drivers.
Scanning – if you have a large quantity of paper documents that need to be scanned and introduced to a DMS (Document Management System), then you must consider:
1. How you want the informatio
Scanning – if you have a large quantity of paper documents that need to be scanned and introduced to a DMS (Document Management System), then you must consider:
1. How you want the informatio
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
n to be retrieved and stored; and
2. How you want indexed information to be introduced to the DMS.
The manner with which you plan to access the documents later will determine which file format type the files will be saved under.
2. How you want indexed information to be introduced to the DMS.
The manner with which you plan to access the documents later will determine which file format type the files will be saved under.
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 most common types for scanning output are .tif and .pdf.
The advantage of .tif file types is that they are the smallest file types and therefore take up the least amount of storage space. The advantage to .pdf file types is th
The advantage of .tif file types is that they are the smallest file types and therefore take up the least amount of storage space. The advantage to .pdf file types is th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
t they provide better options for content text searching (searching every word of a document), are easier to edit, and are overall more flexible.
The method of introducing indexed information (any field used to search and categori
The method of introducing indexed information (any field used to search and categori
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
ze documents) can range from fully automated to fully manual to somewhere in between. The more automated the process, the more file processing will be required. Extensive automation will make your project more complex and costly, b
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t if you handle a large volume of documents, the automation will quickly pay off in the form of reduced manpower.
The actual physical scanning of the documents can also be fairly automated with batch scanning, bar codes, and datab
The actual physical scanning of the documents can also be fairly automated with batch scanning, bar codes, and datab
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ase validation. Batch scanning reduces the labor in introducing the documents to the scanner. Instead of the scanner operator separating every document, scanning it separately, and then saving the file into a directory, the operato
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
r simply places all of the documents into a feeder by the bulk. The scanner then detects a document change by a blank sheet, bar code, or some other indicator.
Bar codes can also be used to represent a group of information or a cl
Bar codes can also be used to represent a group of information or a cl
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ent or project to populate multiple indexed fields. If you have an existing client database in your current ERP system or even QuickBooks, this data can also be used to populate or validate indexed fields.
Capturing electronic fil
Capturing electronic fil
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
es – Existing electronic files - such as .doc, .xls, .dwg, and .dgn, - are easier to capture into a DMS. These files contain hidden properties called metadata, which can be mapped to a field in the DMS. This information might inclu
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
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 created date, author, title, title block, and other useful information.
Once this data is mapped, these fields will be automatically populated when the electronic files are introduced. These files may be saved to a directory int
Once this data is mapped, these fields will be automatically populated when the electronic files are introduced. These files may be saved to a directory int
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
o which the DMS imports them, files may be dragged into the system, or a mass import may be used to bring in legacy documents.
Electronic files may also be captured through print drivers. If you commonly print reports from an appl
Electronic files may also be captured through print drivers. If you commonly print reports from an appl
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ication or save them to a directory, you may use a print driver to introduce them to the DMS, which will ultimately save time. Faxes may also be saved to a directory from which the DMS can pick them up for distribution before they
.
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
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
ver go to paper.
File capture is relatively easy, but a simple digital file without any additional processing isn't much use. You may take the file and name it and file it in Windows Explorer, but when you are cataloging hundreds
File capture is relatively easy, but a simple digital file without any additional processing isn't much use. You may take the file and name it and file it in Windows Explorer, but when you are cataloging hundreds
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
or thousands of files, this is not a feasible system. Human error, if nothing else, will prevent every single file from being named correctly and stored in the proper location. Even one misplaced file can wreak havoc for a 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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