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<b>Audit Services for Biotech and Medical Device Companies</b> </font>
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	Companies developing software in regulated industries must maintain compliance with regulations such
	as the FDA Quality System Regulation as well as standards from organizations such as ISO, IEC, and
	AAMI.
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	<b>Audit Services </font></b><p>
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	Properly planned audits can identify gaps in your present quality system and
	opportunities for improvements. </b>
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	<p> <b>Examples of typical audits include: </b></font>
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		<li>FDA Design Control Compliance Audit<p>
		<li>21 CFR Part 11 Compliance Audit<p>
		<li>ISO 9001 Compliance Audit<p>
		<li>Quality and Process Audits<p>
		<li>Due Diligence Audit<p>
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	Each audit begins with an Audit Plan that identifies what, when, where, and who. The Audit Plan is
	reviewed and approved prior to the audit. Members of the client's staff are encouraged to participate
	on the Audit Team. Once the audit is completed, an Audit Report is prepared, and if requested, a
	detailed "gap analysis" is provided.
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	<b>Relevant Audit Experience:</b></font>
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	<li>ASQ Certified Quality Auditor (CQA) since 1994<p>
	<li>ISO 9000 Lead Assessor Training <p>
	<li>SEI CMM Assessor Training <p>
	<li>Lead Auditor on dozens of audits covering Development and Manufacturing<p>
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	Let my experience in software engineering, medical device software development, training, and
	auditing, help identify those aspects of your development process that need to be brought into
	compliance with the regulations and standards.
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	<b>Working collabratively with your staff, we develop a cost-effective process that not only is compliant
	but also meets your business objectives. </b>This approach provides the best return on investment.
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	<A HREF=medicalexamples.html>Click here</a> for brief summaries of past consulting engagements.
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<b>For further information,
<p>call Steve Rakitin at <font size="3" color=Red face="Arial">508.529.4282</font>
<p><font size="3" color=Black face="Arial">or e-mail him at
<a href="mailto:[email protected]"><b>[email protected]</a></b><p><br>

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	Food for Thought and Predictable Software Development are trademarks of Software Quality Consulting, Inc.<br>
	Copyright �2008 Software Quality Consulting, Inc. All rights reserved.<br>
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    Updated January 2008</font></p>
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