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In order to fully understand the nature of an IT auditor’s work, it is best that you learn the fundamental of IT

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

auditing i.e.: -

What is IT Audit?
What is the scope of an IT Audit?
Why perform IT au

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

Examples of combination products may in

it?

IT Risks

What is IT Audit?

IT = Technology (system/process/method

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

to produce the information required by the users.

Information = Data that has been processed to suit the user r

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

equirements

Audit = assurance and consulting activities

IT Audit is just another branch of audit. It is basical

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

Combination pro

y an assurance and consulting activities designed to add value and improve the IT operations.

Interesting websit

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

s on IT Audit that you can refer to :-

http://www.theii

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

a.org/itaudit/

http://www.isaca.org/

What is

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

the scope of an IT Audit?

According to FFIEC Information TechnologyExamination Handbook, the typica

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

scope of an IT audit :-

Management
Operations
Development & Acquisition
Info

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

mation Security

Business Continuity Planning

As per COBIT, the scope of an IT audit covers the

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

Following aspects would a

followings:-

Plan & Organise (PO)
Acquire & Implement (AI)
Deliver & Support (DS)

dd to the challenges in developing combination products:

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

li>Monitor & Evaluate (ME) Whether you are using FFIEC, COBIT or any other methodology, the most import

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

nt thing is to understand your IT environment and how its support the organisation business.

Why perf

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

orm IT audit?

The objective of an IT audit is to assess the adequacy of the controls in place to sa

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

eguard the informational assets.

In other words, to review the level of IT risks, controls and exposure. My simp

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

Professional from academic institutions, pharmaceutical industries, health care indust

e equation is: -

IT Risk – IT Control = IT Exposure

Therefore, an IT auditor needs to assess the level of IT ri

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

sks and controls that exist in order to determine whether there is any exposure in the organisation.

.

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

T Risks

There are many ways to classify the IT risks.

One of the methods is: -

Infrastruc

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

Companies that provide selfless information through particip

ure Risk

Availability Risk

Integrity Risk

Access Risk

Relevance Risk

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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Whenever you have problems that require some investigation in the Philippines, the country has a number of private investigators that will be able to help you out. There are several Philippine private investigation agencies that are usually affiliated with other agencies from other countries for cases requiring international assistance.

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