Digg It - Business

Is your office buried under a flood of papers? If so, you are not alone. Papers are accumulated everywhere: employees maintain a personal archive, each office maintains an archi

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

ve and then there is an official company archive. The result is storage requirements for paper documents grows at a rate of 20-25% every year.

If that cost alone wasn’t

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

Examples of combination products may in

hurting businesses, Sarbanes-Oxley now requires businesses to properly maintain and quickly retrieve many business records. Morgan Stanley failed to properly retain and produce

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

records related to several investigations and were forced to settle with the Securities and Exchange Commission (SEC) for a record $15 million.

Many companies look to of

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

f-site storage companies to store their company documents and help with easy retrieval. This solves the storage problem; but can be very costly depending on the size of your bus

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

Combination pro

iness and how often you need to retrieve documents. While a truly paperless office may be years away, it might be time to convert your records to digital copies. The advantages

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

of digital archive include:

Reduce storage costs - Eliminate the costs of storage space or the expense of an off-site storage service.
Reduce retrieval costs -

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

When documents are converted to digital files, they are more quickly found and can be accessed by any office or emailed where needed.

Increase security - You can contr

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

ol access to digital files, and maintain a history of who reads any document. Employees don’t have to carry copies that are easily lost.

Regulatory compliance - Sarbane

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-Oxley, HIPAA and FACTA require organizations to maintain appropriate security and controls for many company records. You can maintain every record on a “need to know” basis.

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

li> The process of scanning paper documents and converting them to digital images is called document conversion. Once scanned, the digital images are stored on a server or

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

Following aspects would a

on removable media like tapes and CDs. This can be done in-house or with a scanning service.

There are several steps to the conversion process:

Pre-processi

dd to the challenges in developing combination products:

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

ng: Preparing the documents for scanning. Including removing them from bindings like folder or staples. The documents are arranged in sequence for scanning.

Scannin

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

g: The physical act of creating the digital image of each page.

Format conversion: Converting the scanned documents to the desired format. For example: PDF or Micros

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

oft Word files.

Indexing: This is a description tag placed on every document for quick retrieval.

Quality check: Every digital image should be checked for r

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

eadability. The indexing criteria should also be verified. If any errors are detected they will be re-scanned.

Long term storage: Moving the digital images to a server.

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

Professional from academic institutions, pharmaceutical industries, health care indust

You should always back up and store the archive in a separate location. Many companies find that a scanning service saves money over buying a high capacity scanner a

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

nd paying employees to perform the work. A scanning service is also an expert on indexing and will make your documents easier to find after converted.

Before hiring a

.

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

scanning service, you will want to prepare a good specification that details the number of documents to be converted, the types of documents to be scanned, if the project needs t

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

Companies that provide selfless information through particip

o be done at your location and the required document image type. This will allow a service to give you an accurate quote and prevent any misunderstanding about your expectations

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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