Instrument Validation and CFR-Compliant Software

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


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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