Services

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0 height="100%"><tr> <td valign="top" width=215 BGCOLOR="#000000" TEXT="#F7F7FF"> <bR> <div> <I><B>Skriptek Partners, Inc.</B></I></div> <bR> <bR> <bR> <div> <IMG SRC="04fd5c60.jpg" border=0 width="213" height="198" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></div> <bR> </td> <td valign="top" BGCOLOR="#000000" TEXT="#F7F7FF"> <bR> <div> <A HREF="id18.htm" TARGET="_top" TITLE="Products "><U>Products </U></A>   |   <B>Services</B>   |   <A HREF="id17.htm" TARGET="_top" TITLE="Request Information"><U>Request Information</U></A>   |   <A HREF="id23.htm" TARGET="_top" TITLE="Contact Us"><U>Contact Us</U></A>    |     <A HREF="index.htm" TARGET="_top" TITLE="SkripTek Partners, Inc."><U>home</U></A><IMG SRC="046c39b0.jpg" border=0 width="195" height="155" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></div> <div> Services</div> <div> Changes occuring in regulations and organizations due to acquisitions, mergers, and technology are happening at a rapid pace. These changes might demand new processes, and new systems.<FONT SIZE="2" COLOR="#009900" FACE="Arial" > </FONT>Oftentimes, the expertise needed to react to those changes may not be available in your organization.<FONT SIZE="1" COLOR="#FFFFFF" FACE="Verdana" > </FONT><FONT SIZE="4" COLOR="#0099CC" FACE="BrushScript BT" ><B>Skrip</B></FONT><FONT SIZE="1" COLOR="#0099CC" FACE="Comic Sans MS" ><B>Tek</B></FONT><FONT SIZE="1" COLOR="#990000" FACE="Comic Sans MS" ><B> </B></FONT>can provide professionals with expertise to help you make the right decisions when you respond to the challenges provided by those changes. We will work with you to improve productivity when you respond to change.</div> <bR> <div> Our approach is to provide services that will enhance your business operations while helping you to be compliant with regulatory requirements.</div> <bR> <div> <B>Skrip</B><FONT SIZE="1" COLOR="#0099CC" FACE="Comic Sans MS" ><B>Tek</B></FONT><FONT SIZE="1" COLOR="#990000" FACE="Comic Sans MS" ><B> </B></FONT><FONT SIZE="1" COLOR="#00FF00" FACE="Comic Sans MS" ><B> </B></FONT><FONT SIZE="2" COLOR="#FFFFFF" FACE="Arial" >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 Group Technology, QA Edge, Artech Associates, 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.</FONT></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> <A HREF="id17.htm" TARGET="_top" TITLE="Request Information"><U><IMG SRC="08539330.jpg" border=0 width="57" height="51" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></U></A>Click here to request additional information about Regulatory and Validation Services.</div> <bR> <bR> <div> <IMG SRC="07d55210.jpg" border=0 width="597" height="33" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></div> <bR> <bR> <bR> </td> </tr></table></body>