Validation & Compliance Services

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0><tr> <td valign="top" rowspan="2" width=150 BGCOLOR="#FFFFFF" TEXT="#080000"> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <div> <B><IMG BORDER="0" SRC="Symb075c00b700a066000000.png" HEIGHT="11" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Validation & Compliance Services</B></div> <div> <A HREF="id55.htm" TARGET="_top" TITLE="Compliance Training"><U>Compliance Training</U></A></div> <div> <A HREF="id54.htm" TARGET="_top" TITLE="Project Management"><U>Project Management</U></A></div> </td> <td valign="top" colspan=2 height=95 BGCOLOR="#FFFFFF" TEXT="#080000"> <div> <FONT SIZE="5" COLOR="#FFFFFF" FACE="BrushScript BT" ><B>Skrip</B></FONT><FONT SIZE="2" COLOR="#FFFFFF" FACE="Comic Sans MS" ><B>Tek</B></FONT><FONT SIZE="5" COLOR="#FFFFFF" FACE="Trebuchet MS" > </FONT><FONT SIZE="5" COLOR="#FFFFFF" FACE="Arial" >Partners.</FONT>    <A HREF="index.htm" TARGET="_top" TITLE="SkripTek Partners, Inc."><U>home</U></A><FONT SIZE="5" COLOR="#FFFFFF" FACE="Arial" >, In        </FONT><B> </B><B> </B></div> <div> <I><B>"Productivity and Compliance are NO LONGER mutually exclusive."</B></I></div> <bR> <div> <A HREF="id17.htm" TARGET="_top" TITLE="About Us"><U>About Us</U></A>   ·   <A HREF="id19.htm" TARGET="_top" TITLE="Contact Us"><U>Contact Us</U></A>   ·   <A HREF="id39.htm" TARGET="_top" TITLE="Information Request"><U>Information Request</U></A>   ·   <A HREF="id31.htm" TARGET="_top" TITLE="Premium Partners"><U>Premium Partners</U></A>   ·   <A HREF="id20.htm" TARGET="_top" TITLE="Products"><U>Products</U></A>   ·   <A HREF="id49.htm" TARGET="_top" TITLE="Services"><U>Services</U></A>       </div> <bR> <bR> <bR> <bR> <bR> <bR> <div> </div> </td> </tr><tr> <td valign="top" height=385 colspan=2 BGCOLOR="#FFFFFF" TEXT="#080000"> <bR> <div> <I>Validation & Compliance Services</I></div> <bR> <DIV ALIGN="LEFT"></DIV> <div> <B>"Validation is a bi-product of a good software lifecycle."</B></div> <bR> <div> <FONT SIZE="4" COLOR="#990000" FACE="BrushScript BT" ><B>Skrip</B></FONT><FONT SIZE="1" COLOR="#990000" FACE="Comic Sans MS" ><B>Tek</B></FONT><FONT SIZE="1" COLOR="#00FF00" FACE="Comic Sans MS" ><B> </B></FONT>partners with key providers of computer validation services. A complete suite of validation and documentation activities tuned to your requirements are available. We can provide consulting advice, Quality System design and implementation, full validation management, staff augmentation, or any level of services in between. Partnering with QA Edge, Artech Associates, MojoCommerce, and other validation professionals, allows us to bring expertise to assist clients in meeting the high standards for regulatory compliance established by the FDA. System Validation service offerings include validating individual computer systems, computer systems validation staff augmentation, IS/IT Quality System development consulting, and IS/IT Quality System Management Services.</div> <bR> <div> <B>Testing Services</B></div> <bR> <div> One of the keys to good computer systems validation is demonstrating through documented evidence that systems fulfill the requirements for which they were designed. QA Edge consultants are experts in planning, executing and documenting testing efforts. These experts will assist clients in testing in existing software development/validation methodologies and in developing new strategies for efficient and thorough testing of computer systems. We can also provide testers that are trained in automated testing tools. QLS professionals can help you interface the Electronic Validation Manager (DOORS) with testing tools like Mercury Test Director.</div> <bR> <div> <B>Compliance Assessment</B></div> <bR> <div> We can help you develop a strategy for compliance throughout your organization. This includes procedures and tools for inventory and assessment. We can also execute the strategy and/or perform Part 11 Assessment training to a select group of internal assessors. Our team is focused on providing realistic assessments which are sorted by business/regulatory criticality. Most of all we are focused on delivering assessment results on-time and with minimal disruption to your organization. We can perform third-party audits of vendors to assess control over design, testing and customer support. We have also performed audits of CRO's to assess control over their systems and their ability to meet the guidelines proposed by sponsoring pharmaceutical companies. </div> <bR> <div> <B>QA Edge Guarantee</B></div> <bR> <div> Any documents authored by QA Edge, Inc. will pass an FDA inspection or we will correct the documents at our cost.</div> <div>  <FONT SIZE="1" COLOR="#FFFFFF" FACE="Verdana" ><IMG SRC="0abfa8b0.gif" border=0 width="250" height="139" ALIGN="LEFT" HSPACE="44" VSPACE="0"></FONT></div> <div> QA Edge will always:</div> <bR> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Provide highly trained consultants with the expertise in the process of developing high-quality validated solutions. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Listen to our customers to insure that their needs are understood and expectations exceeded. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Sustain accountability for the value of solution and services that we provide. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Focus on customer service excellence. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Deliver high-quality compliant systems in a manner that meets or exceeds our customers’ deadlines. </div> <div> Maintain open and honest communications with our customers during each project.</div> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> <bR> </td> </tr></table></body>