Quality and Compliance - The Next Generation of Systems for Compliance

[Quality and Compliance]

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Mar 2005

	Quality System Requirements for Outsourced Manufacturing
	After outsourcing manufacturing to lower cost countries, many companies find new demands imposed on their quality management processes. As a result, many companies find their existing quality management systems to be no longer effective. This is especially true if their existing quality system is either paper-based or implemented using a PC-based point solution. This article identifies the quality management requirements for an outsourced manufacturing environment and explains how companies that outsource manufacturing can still maintain a clear visibility into their outsourcer?s process capability and their overall product quality.
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	The Next Generation of Systems for Compliance
	Companies are governed by a complex web of regulations, laws, voluntary codes, industry codes, and corporate policies. Compliance with these intricate regulations, mandates and policies is not an easy task. Maintaining ongoing compliance is even more difficult due to continuous changes, amendments and overlaps. Inability to comply with the regulations can lead to large penalties or even temporary suspension of operations. Hence compliance is about protecting an organization?s license to operate ? lack of compliance introduces a substantial financial and operational risk to an organization. As a result, compliance is very closely related to risk management.
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	How to build a Business Case for a Quality Management System
	Most enterprise software projects require its champion to build a business case to justify the capital spend. In building a business case, the champion needs to capture all tangible benefits that the company would obtain from implementing the software and then place a defensible monetary value on these benefits in terms of annual savings to the organization. The goal of the business case is to ensure that the project delivers value greater than the corporate hurdle rate for capital investments. This paper provides a proven step-by-step process to developing a business case for a Quality Management System (QMS) within an enterprise.
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	Smart Investment Strategies for a Compliance Platform: A Ten Step Guide
	Government regulations and mandates are on the rise. Most corporate compliance offices are challenged to find compliance solutions that can scale across corporate compliance offices and also manage regulatory and compliance initiatives within respective operational and departmental areas. This article highlights the importance of selecting the right compliance platform, which can scale across different regulations (federal and state regulations, 21CFR part11, Sarbanes-Oxley, OSHA, internal governance initiatives etc.) while serving users across the enterprise. Most corporations have diverse systems and processes and the challenge always is on monitoring and reporting compliance events and trends across the enterprise.
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	MetricStream partners with Compliance Online Industry's first portal for quality and regulatory compliance professionals

AMR Research Predicts Compliance Is an $80B Issue;
Companies Will Spend $15.5B on Compliance in 2005

Compliance Spending by Category

$ millions	SOX	HIPAA	FDA	SEC	Other	Total
Technology	$1,712	$1,546	$375	$452	$1,118	$5,202
3rd Party Services	$1,773	$523	$288	$335	$866	$3,785
Internal Staff	$2,568	$1,571	$394	$449	$1,215	$6,196
Other	$61	$38	$42	$71	$86	$299
Total	$6,114	$3,678	$1,099	$1,307	$3,285	$15,483

Percentage of Companies Addressing Compliance Mandates

60%	- Sarbanes Oxley Section 404 (SOX)
52%	- Document and Record Retention Requirements
42%	- Code of Conduct / Training Requirements
39%	- Health Insurance Portability and Accountability Act (HIPAA)
30%	- SEC Regulations
20%	- FDA Regulations (21 CFR Part 11)
7%	- TREAD Act (Automotive)
5%	- Basel II

Links to papers in the prior newsletter issues
		Best Practices in CAPA			Supplier Chargebacks & Cost Recovery
		Workplace Safety Compliance			IT Systems Validation for SOx and Regulatory Compliance

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