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It is inevitable. It happens every year. Hiding from it or ignoring it won’t make it go away. The dreaded company audit; there is no way around it, so com

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

panies must do their best to comply with the current standards. And to be able to prove that they are meeting those standards. The compliance regulations c

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

Examples of combination products may in

mpanies must strive to meet are HIPAA for the medical field and Sarbanes-Oxley regarding any company’s financial records.

There are records management syste

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

s today that make the auditing process simple and painless. Each time there is activity within the records management system, the event is recorded to a lo

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

file. For example, when a medical record is updated by a doctor, the event is recorded, dated, and saved for future confirmation. If a company document is

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

Combination pro

deleted from the records management system, that occurrence is noted and logged.

Another advantage to using an auditing program in conjunction with your rec

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

ords management system is that in a sense, security is increased. In other words, the auditing programs have the ability to record each system login, logout

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

or bad password attempt. Companies are able to track such important information and evaluate any security issues.

Additionally, on an individual basis, a

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

ecords management system audit program allows the auditing of specific users. The system records the activities of predefined, selected users. With this fe

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

ture activated and configured, there will be no question as to “who did what.”

Through the records management system, your company has a means of controllin

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

the activities within the system. These options are configured and set up during the installation process. A user or a group of users may be prevented fro

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

Following aspects would a

m modifying or deleting company records. This ensures that the documents do not get wrongfully changed or deleted. This feature allows your company to demo

dd to the challenges in developing combination products:

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

strate that important records are secure and can never be lost.

To further take advantage of this technology and end possible compliance problems, some audi

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

ing program packages include email alert messaging. The value of email messages is that a designated auditor is immediately alerted to information, such as

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

ystem startup or shutdown, database space availability, and user access denied.

From the data captured in your records management system, audit reports are

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

enerated. The reports contain information such as the presence or absence of documents, identification of document dates, document counts, and the occurrenc

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

Professional from academic institutions, pharmaceutical industries, health care indust

e of events within the system.

It takes a great deal of time and effort to operate and manage a company today. Installing a records management system with

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

uditing capabilities lessens the anxiety over auditing and allows your company to concentrate on its productivity and success.

Does your company sweat it ou

.

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

each year during the auditing process? Can your company afford the time it takes to investigate the deletion or modification of a customer record? Researc

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

Companies that provide selfless information through particip

the solutions available to these and other compliance-related issues by investing in an electronic records management system with audit logging capabilities

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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