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The Sarbanes Oxley Act of 2002 (SOX) has set in place some of the toughest corporate governance standards in the world. In light of the ongoing enforcement of such accountability legislation, the need for software solutions to help organiz

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

ations manage the challenges associated with Sarbanes Oxley compliance is tremendous. There are a number of points to be considered when seeking out Sarbanes Oxley software.

A good Sarbanes Oxley software solution should provide an integr

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

Examples of combination products may in

ated platform with specific modules designed to meet all of your SOX 302 and 404 needs. Integration points for document management, control monitoring, business intelligence and internal auditing are key. Adopting an integrated architectur

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

e reduces the time and effort involved in gathering and reporting on Sarbanes Oxley compliance, risk management, and other governance data.

Such a tool should also help organizations meet additional governance responsibilities including t

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

e standards set out in the COSO ERM framework and emerging Basel II requirements. It should identify problems, monitor process performance, assign responsibilities and prioritize action items. It goes without saying that an ideal Sarbanes

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

Combination pro

Oxley software solution should be able to be customized to meet the unique needs of your organization.

Case Study: McDonald’s Corporation

New requirements for internal auditing and operational risk management demand the development of po

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

werful solutions to address the specific needs of Sarbanes Oxley as well as broader governance requirements. This is true as much for mid-market organizations as it is for multinational corporations.

For example, McDonald's Corporation, t

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

he fast-food giant, has been in business for 50 years and is worth a reported $19 billion. With more than 32,000 locations in 120 countries around the world, McDonald's is perhaps the most visible corporate brand. The corporation owns near

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

y 30 percent of its locations directly, and employs more than 435,000 people.

As early as 2003, well before the final regulations enforcing the Sarbanes Oxley Act were written, McDonald's executives knew they faced a tremendous challenge

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

in complying with sections 302 and 404 of the law. Its auditors and managing executives would be busy enough just working with local business units to ensure that deadlines were met and correct data gathered. The company needed a proven IT

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

platform to serve as a framework and repository for that crucial compliance work.

McDonald’s knew it wanted to use an industry leading, risk-based framework built on standards from the Committee of Sponsoring Organizations (COSO), since

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

Following aspects would a

the COSO framework was already well-known and had the support of important regulatory boards such as the Public Company Accounting Oversight Board (PCAOB). The solution needed to be able to be easily bolted onto McDonald's systems and allo

dd to the challenges in developing combination products:

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

SOX project managers to work immediately.

Paisley Consulting, the recognized global leader in corporate governance, enterprise risk management and audit management, offered the proven solution that McDonald's was looking for. Risk Naviga

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

tor® would let McDonald's Global Sarbanes Oxley team load a standard set of controls into the tool, and then coordinate a global compliance effort where the core team could direct specific business units to focus on specific controls at ce

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

rtain times.

The Risk Navigator solution was initially phased in starting in the fall of 2003 beginning with a pilot program in Great Britain. Excel spreadsheets were used to load the global standard COSO framework into Risk Navigator for

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

each market. Managers then used the framework to do their documentation and testing. Once the pilot proved successful, McDonald's brought Risk Navigator into its North American and European operations. Asian operations were brought onto t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e system in 2005, and McDonald's plans to include Latin American locations in late 2006.

With the global SOX team collaborating with local teams in an ongoing, sustainable effort, an estimated several hundred McDonald's managers use Risk

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

Navigator today in some capacity. Risk Navigator cleared a path for one of the world's most prominent and geographically diverse businesses to comply with a complicated regulatory measure by the required deadline while empowering them to b

.

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

uild a global repository of best practices for financial operations.

Summation

Keeping up with complex regulations such as the Sarbanes Oxley Act and sustaining those compliance activities with constrained time and resources is a dauntin

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

Companies that provide selfless information through particip

g task for even the most visible businesses. If you’re looking for a more efficient alternative to first-generation Sarbanes Oxley compliance software, spreadsheets and other manual approaches to Sarbanes Oxley, Paisley Consulting can help

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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