Instrument Validation and CFR-Compliant Software

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en-us NU4FB74EH Instrument Validation CFR Compliance Instrument Validation and CFR-Compliant Software /webroot/web/html/lsr/solutions/applications/drug_discovery <script type="text/javascript"><!-- $(document).ready(function(){ $('.pagecontent2').hide(); }); // --></script> <div style="float:right; margin-left:20px; margin-bottom:10px"><img src="http://www.bio-rad.com/webroot/web/images/lsr/products/amplification_pcr/category_feature/global/pcr-instrument-validation-tools-pcp-feature.jpg" alt="" /></div> <p>Bio-Rad recognizes and addresses the needs of researchers in regulated and audited environments. Installation qualification/operation qualification (IQ/OQ) options are available for many of our instruments, either as self-service tools or implemented by our field-service technicians. Additionally, available software options permit users to operate in compliance with Title 21 of the U.S. Code of Federal Regulations Part 11 (21 CFR Part 11).</p> <p>&nbsp;</p> <p><br /></p> <p><strong>Featured products with IQ/OQ and CFR compliance options</strong><strong> </strong></p> <table class="pd_table pd_gridlines" border="0"> <tbody> <tr> <td valign="top"> <p><strong>System</strong></p> </td> <td valign="top"> <p><strong>IQ/OQ Option</strong></p> </td> <td valign="top"> <p><strong>21 CFR Part 11 Compliant Software Option</strong></p> </td> </tr> <tr> <td> <p><a href="/en-us/category/real-time-pcr-detection-systems">CFX Real-Time PCR Detection Systems</a><br />Use the CFX Automation System II and CFX Real-Time PCR Systems to automate workflows and generate large volumes of data with rapid analysis.</p> </td> <td> <p><a href="/en-us/category/pcr-instrument-validation-tools-services">PCR Validation Services</a></p> </td> <td> <p><a href="/en-us/product/cfx-manager-software-security-edition">CFX Manager&trade; Software, Security Edition</a></p> </td> </tr> <tr> <td> <p><a href="/en-us/category/bio-plex-multiplex-system">Bio-Plex<sup>&reg;</sup> Multiplex Immunoassay System </a><br /> Utilize Luminex xMAP technology to simultaneously detect and quantify up to 100 analytes in a single small sample.</p> </td> <td> <p><a href="/en-us/category/bio-plex-multiplex-system">Bio-Plex Validation Tools</a></p> </td> <td> <p><a href="/en-us/product/bio-plex-manager-software-security-edition">Bio-Plex Manager&trade; Software, Security Edition</a></p> </td> </tr> <tr> <td> <p><a href="/en-us/product/gs-900-calibrated-densitometer">GS-900&trade; Calibrated Densitometer</a><br /> Use this self-calibrating imaging system to reproducibly image gels, blots, and film and quantitate proteins in cGMP environments.</p> </td> <td> <p><a href="/en-us/sku/1707994-gs-900-installation-qualification-operations-qualification-iq-oq-kit">GS-900 IQ/OQ Kit</a></p> </td> <td> <p><a href="/en-us/sku/1707993-gs-900-calibrated-densitometer-regulatory-tools-package">GS-900 Regulatory Tools Package </a></p> </td> </tr> <tr> <td> <p><a href="/en-us/category/ngc-medium-pressure-liquid-chromatography-systems">NGC&trade; Modular FPLC System </a><br /> The modular NGC System is easily reconfigured to meet a range of throughput and application needs: analytical, preparative, and scale-up.</p> </td> <td> <p><a href="/en-us/product/iq-oq-services-for-ngc-chromatography-systems">NGC IQ/OQ Services</a></p> </td> <td> <p><a href="/en-us/product/chromlab-software-security-edition">ChromLab&trade; Software, Security Edition</a></p> </td> </tr> </tbody> </table> <p>&nbsp;</p> Karen Moss Instrument Validation and CFR-Compliant Software Bio-Rad provides instrument validation and CFR compliance services for GMP facilities and FDA-regulated manufacturing. drug discovery, discovery, drug development, development, pharma, pharmaceutical, fda, validation, instrument validation, cfr, compliance, regulated, regulatory 10/07/15 02:24 PM 10/07/25 02:26 PM AE,AI,AL,AM,AR,AT,AU,AZ,BA,BD,BE,BF,BG,BH,BN,BO,BR,BW,CA,CH,CL,CM,CN,CO,CR,CY,CZ,DE,DK,DO,DZ,EC,EE,EG,EH,ER,ES,ET,FI,FM,FO,FR,GA,GE,GF,GH,GP,GR,GT,GU,HK,HN,HR,HT,HU,ID,IE,IL,IN,IS,IT,JM,JO,JP,KE,KH,KR,KW,KZ,LB,LI,LK,LT,LU,LV,MA,MD,MG,MK,ML,MO,MQ,MS,MT,MU,MX,MY,NG,NI,NL,NO,NP,NZ,OM,PA,PE,PF,PG,PH,PK,PL,PR,PS,PT,PW,PY,QA,RO,RS,RU,SA,SB,SE,SG,SI,SK,SN,ST,SV,TG,TH,TN,TO,TR,TT,TW,TZ,UA,UG,UK,US,UY,UZ,VA,VE,VU,XK,YE,ZA en LSR /LSR/Applications/Drug_Discovery N 0 Drug Discovery and Development /en-us/applications-technologies/applications-technologies/instrument-validation-cfr-compliant-software?ID=NU4EE515

Bio-Rad recognizes and addresses the needs of researchers in regulated and audited environments. Installation qualification/operation qualification (IQ/OQ) options are available for many of our instruments, either as self-service tools or implemented by our field-service technicians. Additionally, available software options permit users to operate in compliance with Title 21 of the U.S. Code of Federal Regulations Part 11 (21 CFR Part 11).

 


Featured products with IQ/OQ and CFR compliance options

System

IQ/OQ Option

21 CFR Part 11 Compliant Software Option

CFX Real-Time PCR Detection Systems
Use the CFX Automation System II and CFX Real-Time PCR Systems to automate workflows and generate large volumes of data with rapid analysis.

PCR Validation Services

CFX Manager™ Software, Security Edition

Bio-Plex® Multiplex Immunoassay System
Utilize Luminex xMAP technology to simultaneously detect and quantify up to 100 analytes in a single small sample.

Bio-Plex Validation Tools

Bio-Plex Manager™ Software, Security Edition

GS-900™ Calibrated Densitometer
Use this self-calibrating imaging system to reproducibly image gels, blots, and film and quantitate proteins in cGMP environments.

GS-900 IQ/OQ Kit

GS-900 Regulatory Tools Package

NGC™ Modular FPLC System
The modular NGC System is easily reconfigured to meet a range of throughput and application needs: analytical, preparative, and scale-up.

NGC IQ/OQ Services

ChromLab™ Software, Security Edition

 

 
 
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Installation qualification/operation qualification (IQ/OQ) options are available for many of our instruments, either as self-service tools or implemented by our field-service technicians. Additionally, available software options permit users to operate in compliance with Title 21 of the U.S. Code of Federal Regulations Part 11 (21 CFR Part 11).</p> <p>&nbsp;</p> <p><br /></p> <p><strong>Featured products with IQ/OQ and CFR compliance options</strong><strong> </strong></p> <table class="pd_table pd_gridlines" border="0"> <tbody> <tr> <td valign="top"> <p><strong>System</strong></p> </td> <td valign="top"> <p><strong>IQ/OQ Option</strong></p> </td> <td valign="top"> <p><strong>21 CFR Part 11 Compliant Software Option</strong></p> </td> </tr> <tr> <td> <p><a href="/en-us/category/real-time-pcr-detection-systems">CFX Real-Time PCR Detection Systems</a><br />Use the CFX Automation System II and CFX Real-Time PCR Systems to automate workflows and generate large volumes of data with rapid analysis.</p> </td> <td> <p><a href="/en-us/category/pcr-instrument-validation-tools-services">PCR Validation Services</a></p> </td> <td> <p><a href="/en-us/product/cfx-manager-software-security-edition">CFX Manager&trade; Software, Security Edition</a></p> </td> </tr> <tr> <td> <p><a href="/en-us/category/bio-plex-multiplex-system">Bio-Plex<sup>&reg;</sup> Multiplex Immunoassay System </a><br /> Utilize Luminex xMAP technology to simultaneously detect and quantify up to 100 analytes in a single small sample.</p> </td> <td> <p><a href="/en-us/category/bio-plex-multiplex-system">Bio-Plex Validation Tools</a></p> </td> <td> <p><a href="/en-us/product/bio-plex-manager-software-security-edition">Bio-Plex Manager&trade; Software, Security Edition</a></p> </td> </tr> <tr> <td> <p><a href="/en-us/product/gs-900-calibrated-densitometer">GS-900&trade; Calibrated Densitometer</a><br /> Use this self-calibrating imaging system to reproducibly image gels, blots, and film and quantitate proteins in cGMP environments.</p> </td> <td> <p><a href="/en-us/sku/1707994-gs-900-installation-qualification-operations-qualification-iq-oq-kit">GS-900 IQ/OQ Kit</a></p> </td> <td> <p><a href="/en-us/sku/1707993-gs-900-calibrated-densitometer-regulatory-tools-package">GS-900 Regulatory Tools Package </a></p> </td> </tr> <tr> <td> <p><a href="/en-us/category/ngc-medium-pressure-liquid-chromatography-systems">NGC&trade; Modular FPLC System </a><br /> The modular NGC System is easily reconfigured to meet a range of throughput and application needs: analytical, preparative, and scale-up.</p> </td> <td> <p><a href="/en-us/product/iq-oq-services-for-ngc-chromatography-systems">NGC IQ/OQ Services</a></p> </td> <td> <p><a href="/en-us/product/chromlab-software-security-edition">ChromLab&trade; Software, Security Edition</a></p> </td> </tr> </tbody> </table> <p>&nbsp;</p> Karen Moss Instrument Validation and CFR-Compliant Software Bio-Rad provides instrument validation and CFR compliance services for GMP facilities and FDA-regulated manufacturing. drug discovery, discovery, drug development, development, pharma, pharmaceutical, fda, validation, instrument validation, cfr, compliance, regulated, regulatory 10/07/15 02:24 PM 10/07/25 02:26 PM AE,AI,AL,AM,AR,AT,AU,AZ,BA,BD,BE,BF,BG,BH,BN,BO,BR,BW,CA,CH,CL,CM,CN,CO,CR,CY,CZ,DE,DK,DO,DZ,EC,EE,EG,EH,ER,ES,ET,FI,FM,FO,FR,GA,GE,GF,GH,GP,GR,GT,GU,HK,HN,HR,HT,HU,ID,IE,IL,IN,IS,IT,JM,JO,JP,KE,KH,KR,KW,KZ,LB,LI,LK,LT,LU,LV,MA,MD,MG,MK,ML,MO,MQ,MS,MT,MU,MX,MY,NG,NI,NL,NO,NP,NZ,OM,PA,PE,PF,PG,PH,PK,PL,PR,PS,PT,PW,PY,QA,RO,RS,RU,SA,SB,SE,SG,SI,SK,SN,ST,SV,TG,TH,TN,TO,TR,TT,TW,TZ,UA,UG,UK,US,UY,UZ,VA,VE,VU,XK,YE,ZA en LSR /LSR/Applications/Drug_Discovery N 0
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