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<p class="Body-P"><span class="Body-C1">The Foxboro Distributed Control System (DCS) is used to provide automated distributed
control across seven processors for utilities, and pilot plant processing equipment.
The main processes were fermentation and separation sciences. The DCS is made up
of multiple workstations, control processors, and fieldbus modules linked together
on a common network (Nodebus). The Foxboro is based upon the IBM S/88 architecture.
It is a fault tolerant computer system, It will provide uninterrupted seamless service
</span></p>
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<p class="Body-P"><span class="Body-C1">Scope: I was the project manager. I moved the system to another location and separated
fermentation processes activities from the separation processes division. I validated
and remediated the system, I managed.</span></p>
</div>
<div id="txt_198" style="position:absolute; left:28px; top:775px; width:438px; height:16px;-moz-box-sizing:border-box;-webkit-box-sizing:border-box;box-sizing:border-box; overflow:hidden;">
<p class="Body-P"><span class="Body-C2">The software components that were validated were:</span></p>
</div>
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<p class="Body-P"><span class="Body-C1">BDS TCL/TK Client, BDS, Server Module, OAJ Host Module, Client Module, SysMon, ICC
Driver, *Aimstar Historian, Fox View, Fox Draw, Foxboro (CTS) Change Tracking Software</span></p>
</div>
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<p class="Body-P"><span class="Body-C2">The hardware components that were validated were:</span></p>
</div>
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<p class="Body-P"><span class="Body-C1">enclosures, fieldbus Modules, Modular Industrial Consoles/Workstations, Processors,
Integrator/Gateway, and, Data storage modules, Reactors, Mix tanks, Receivers, Vacuum
pumps, vaporation skid, Condensers, columns, TPA Transfer pumping station, Building
Utilities, Glycol system, Purified water, Breathing system, Effluent system, regulators,
valves, switches PLCs, etc.</span></p>
</div>
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<p class="Body-P"><span class="Body-C2">I Developed all SDLC documentation such as</span><span class="Body-C3">:</span><span class="Body-C1"> Verification of Inventory, Risk Assessment,
Compliance Assessment, Business Process Diagram, Remediation Plan, Architecture Diagram,
Confidentiality Agreement, Vendor Evaluation Document, Vendor Audit (phone, mail,
and onsite), Summary Report, Requirements Document, Traceability Matrix, IQ Test
Procedure and Scripts, IQ Participants Qualifications, OQ Test Procedure and Scripts,
OQ Participants Qualifications, Configuration Specification, Configuration Qualification
Scripts, Test Summary Log, Phase Review System Operation SOP, Account Management
SOP, System Logbook, PQ Participants Qualifications, </span></p>
</div>
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<p class="Body-P"><span class="Body-C4">DeltaV</span><span class="Body-C1"> </span><span class="Body-C4">Validation</span><span class="Body-C1">. Responsibilities included : Develop and execute GMP DeltaV software
test protocols based on previously authored design documentation to support the conversion
of an existing ABB control system to DeltaV in a biologics facility. Execute the
qualification of the DeltaV Control System by authoring qualification documentation
(IQ, OQ), executing IQ, OQ test scripts, documenting all deviations in investigation
reports. Perform loop checks and installation checks. Execute field commissioning
and troubleshooting of the DeltaV control system, including historian and reports
applications, backup utility, and system integrity. I help develop:</span></p>
</div>
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<p class="Body-P"><span class="Body-C1">Test Procedures and Qualification Templates</span></p>
<p class="Body-P"><span class="Body-C1">Standard DeltaV SOPs</span></p>
<p class="Body-P"><span class="Body-C1">Industry best practices (FMECA, GAMP risk considerations)</span></p>
<p class="Body-P"><span class="Body-C1">DeltaV System Migration Standard Methodology</span></p>
<p class="Body-P"><span class="Body-C1"> </span></p>
</div>
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<div id="txt_205" style="position:absolute; left:35px; top:1354px; width:654px; height:128px;-moz-box-sizing:border-box;-webkit-box-sizing:border-box;box-sizing:border-box; overflow:hidden;">
<p class="Body-P"><span class="Body-C5">The Varian Biotage ST2000XP and the Prochrom LC (NovaSep) are high-<wbr>pressure explosion
proof multi-<wbr>column skid systems. They were controlled by Allen Bradley Programmable
logic Controllers (PLCs). The systems are configured with feedback controlled Low
Pressure Gradient (LPG) formation. Low-<wbr>pressure binary gradient capability is achieved
using two positive displacement flow meters to control the opening of two flow control
valves, one on each inlet channel and to correct the flow of the main solvent delivery
pump. Monitoring capabilities is accomplished by Varians the LC ReSponder software.
LC ReSponder enhances the performance, of the systems. It acquires data and place
it in a graphical display for statistical analysis</span></p>
</div>
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<p class="Body-P"><span class="Body-C5">Scope: Both systems have been configured with Varian’s LC ReSponder software package.
In order to use LC ReSponder The systems configuration files had to be re-<wbr>programmed.
Both systems were being used for clinical development for the USA and Europe. Validation
efforts had to accommodate ICH, European directives, and GXPs initiatives. </span></p>
</div>
<div id="txt_207" style="position:absolute; left:35px; top:1584px; width:654px; height:16px;-moz-box-sizing:border-box;-webkit-box-sizing:border-box;box-sizing:border-box; overflow:hidden;">
<p class="Body-P"><span class="Body-C6">The software components that were validated were:</span></p>
</div>
<div id="txt_208" style="position:absolute; left:35px; top:1619px; width:654px; height:16px;-moz-box-sizing:border-box;-webkit-box-sizing:border-box;box-sizing:border-box; overflow:hidden;">
<p class="Body-P"><span class="Body-C5">LC ReSponder, Configuration and firmware changes in the hardware, Foxboro (DCS) 6.1</span></p>
</div>
<div id="txt_209" style="position:absolute; left:35px; top:1654px; width:654px; height:16px;-moz-box-sizing:border-box;-webkit-box-sizing:border-box;box-sizing:border-box; overflow:hidden;">
<p class="Body-P"><span class="Body-C6">The hardware components that were validated were:</span></p>
</div>
<div id="txt_210" style="position:absolute; left:35px; top:1689px; width:654px; height:16px;-moz-box-sizing:border-box;-webkit-box-sizing:border-box;box-sizing:border-box; overflow:hidden;">
<p class="Body-P"><span class="Body-C5">HPLC detectors, pumps, pressure valves, flow meters</span></p>
</div>
<div id="txt_211" style="position:absolute; left:35px; top:1724px; width:654px; height:64px;-moz-box-sizing:border-box;-webkit-box-sizing:border-box;box-sizing:border-box; overflow:hidden;">
<p class="Body-P"><span class="Body-C6">I develop and coordinated </span><span class="Body-C5">all activities, interviewed and audited Pfizer personnel
and manufacturing representatives, provided or arranged training, developed all procedures
and documentation and arranged approval and storage of all records, reinforced supporting
systems such as change control procedures, etc.</span></p>
</div>
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<p class="Body-P"><span class="Body-C7">COMPUTERIZED SYSTEMS</span></p>
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<p class="Body-P"><span class="Body-C1">VQS develops your procedures and provide the training for attaining your objectives.
What good is validation if the environment cannot support the equipment</span></p>
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<p class="Body-P"><span class="Body-C"><a href="Page 6.html">Production</a></span></p>
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<p class="Body-P"><span class="Body-C"><a href="page10.html">Laboratory</a></span></p>
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<p class="Body-P"><span class="Body-C"><a href="Page 2.html">Validation</a></span></p>
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<p class="Body-P"><span class="Body-C"><a href="Page 3.html">Staffing</a></span></p>
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<div style="position:absolute; left:495px; top:598px; width:9px; height:9px;">
<img src="wpimages/wp0_wpf19b82c0.png" width="9" height="9" border="0" id="qs_241" name="qs_241" title="" alt="" onload="OnLoadPngFix()"></div>
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<p class="Body-P"><span class="Body-C1">Our -<wbr>manufacturing expertise is equally valuable. We have helped remediate an<img src="wpimages/wp0_wpc9b597c9_05.jpg" width="92" height="126" border="0" title="" alt="" style="float:right; margin:0px 0px 0px 0px">d developed
computerized systems for, facilities maintenance and engineering, fermentation and
separation processes, kilo-<wbr>laboratories, pilot-<wbr>laboratories, stability, environmental
controls, glycol systems, clean air systems, USP purified water, WFI, effluent systems,
SCADA (Wonderworks, DeltaV), DCS (Foxboro), Allen-<wbr>Bradley PLCs, digital/analog communications,
tablet presses, sensors, RS232, CAN, USB, Nodebus, profibus, Ethernet, software development,
testing, actuation, control and more.</span></p>
</div>
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<p class="Body-P"><span class="Body-C1">Below you can </span></p>
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<p class="Contact-Details-P"><span class="Contact-Details-C">Validated Quality Systems </span><span class="Contact-Details-C0"> | </span><span class="Contact-Details-C1">VQS</span><span class="Contact-Details-C"> </span><span class="Contact-Details-C2"> </span><span class="Contact-Details-C1">Tel: (215) 290-<wbr>9013</span><span class="Contact-Details-C2"> </span></p>
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