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Research shows that over 75% of businesses are increasingly experiencing unexpected unavailability of their critical business systems due to IT securi

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

ty intrusions(2).

There are many components to consider when developing and implementing a security plan to protect your company's data and systems i

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

Examples of combination products may in

cluding virus scanning, firewalls, protecting wireless network, encryption, installing patches, and actively monitoring for intruders. There is no on

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

-size fits all strategy, but there are some basic elements that companies should adhere to when it comes to IT security.

1. Management Support:

The

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

irst step is ensuring that your senior management team understands and supports the value of a solid IT security plan.

2. Develop & Implement:

Devel

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

Combination pro

p and implement a solid security policy and procedure. This should cover everything from the severs to the workstations to the level of access current

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

employees have to what measure should be taken when an employee leaves the company.

Document all of the IT assets including the data and information

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

hat needs to be protected, and spend the most resources protecting what is most important.

3. Designate A Point Person:

Identify the best person to

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

versee and take full responsibility for coordinating the IT security plan. If you do not have a resource to be dedicated to this on-going project, the

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

consider outsourcing this responsibility to a reputable and proven firm.

4. Response Plan:

Create and test a formal response plan to be executed wh

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

n there is a breach in your IT security plan. Be sure to document who needs to be notified and what steps should be taken. Critical time will be saved

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

Following aspects would a

in the event of a breach and it will help minimize the overall damage.

5. Documentation & Training:

Document and train employees on the established

dd to the challenges in developing combination products:

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

IT security policy and procedures so employees are fully aware of the scope and their responsibilities.

6. Review & Update:

Frequently review and up

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

ate the documentation as new security threats often arise as well as new and enhanced technology to prevent intrusions.

7. Audit:

Have a security au

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

it completed by an external firm. This outside evaluation can provide valuable insight into the flaws or potential vulnerabilities in the security pla

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

.

8. Stay Informed:

New developments are constantly emerging on vulnerabilities and new technology and it's important to stay on top of the industry

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

Professional from academic institutions, pharmaceutical industries, health care indust

changes.

Summary:

Businesses have to be proactive in protecting their critical business information and data. Developing, implementing, and testing

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

comprehensive security plan will ensure that your business does not become another statistic of IT security breaches. ITX provides our clients with

.

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

he analysis and tools needed to mitigate the risk of unauthorized access, deletion, or changes to their IT infrastructures. ITX’s clients have the fre

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

Companies that provide selfless information through particip

dom to choose the technologies that meet their specific needs and improve their business.

(1) Computer Crime & Security Survey
(2 )Ernest & Youn

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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