Advice You - Finance

Security is a major issue for companies providing financial services. The nature of security threats to such companies is mostly of two kinds, iden

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

tity and access. Financial institutions need to monitor the access to crucial data, and see to it that there is no fraud committed through imperson

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

Examples of combination products may in

ation.

While taking care of security issues, financial sectors must also keep in mind costs, maintenance, and updates etc.

Enterprise Security: A

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

ccess and Identity: Identity and access management is about applying the right technology to security applications. Today, security is about autom

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

tion, aligning products, platforms, and utilizing professional services. From isolated systems to integrated security solutions, enterprise securit

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

Combination pro

y has come a long way.

Security Basics: Here are some things to keep in mind when building an enterprise security system.

1) Overheads: Conside

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

r the cost of the application, maintenance, and whether it will help your business become more productive.

2) Quality: Can the system enforce a p

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

lanned password policy? Will it be able to restrict certain kinds of access to certain users?

3) Use: Is the security service easy to use? Can it

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

be accessed from a central location?

Installing an Enterprise Security System:
Setting up a security system is not easy and it involves:

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

• Aligning technology and the functioning of the organization
• Access based on the identity of a person
• Having a strategy in place b

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

efore installing the system
• Centralized access and controls
• Reducing operational complexity

Enterprise Security: Financial Servi

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

Following aspects would a

ces Audit Before setting up an enterprise security service, you need to go in for a comprehensive financial services audit. This will help you ide

dd to the challenges in developing combination products:

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

tify the strengths and weaknesses of your security system. The audit should ideally touch on the following areas.

1) GAP Analysis: This will map

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

the state of security preparedness of your company.

2) Risk Analysis: Do a review of the existing threats to your financial services.

3) Securit

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

y Assessment: Find out any flaws in the security system.

4) Compliance to Regulations: See if the security system complies with various regulati

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

ons.

5) Remedial Measures: Suggest ways to improve flawed security applications.

Enterprise Security: Other Issues Apart from identity and acce

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, other issues that you may need to discuss while going in for a security application are:
1) Malware attacks on your network.
2) Spywar

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

e and Trojan horses.

Hiring the right security service provider is crucial if you wish to guard against the many security threats that can cri

.

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

pple the financial services of your company. There are a number of service providers that will help you plan a strong line of defense, identify and

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

Companies that provide selfless information through particip

rectify the flaws in your security applications, and help with the maintenance and updating of the system. You simply need to select the right one

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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