CFR 21 Part 11

CFR 21 Part 11 is part of the Code of Federal Regulations that establishes requirements by which electronic records must be created, modified, maintained, archived, retrieved or transmitted by Food and Drug Administration (FDA) regulated industries including drug makers, medical device manufacturers, biotech companies, biologics developers, contract research organizations, and others for the purpose of establishing regulatory compliance.

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Sixth Sense PG10 and PG20 Paperless Recorder
Sixth Sense PG10 and PG20 Paperless Recorder
Highly capable quality assurance instruments with advanced features to record and display nearly any industrial signal.
Some Models in Stock
Starting at $1,200.00
Isotech milliK Precision Thermometer
Isotech milliK Precision Thermometer
Range of sensors: SPRTs, PRTs, thermistors, thermocouple and 4-20mA.
$6,606.18
Rotronic HL-1D & TL-1D Data Loggers
Rotronic HL-1D & TL-1D Data Loggers
Cost-effective instruments for monitoring and recording humidity and/or temperature.
Some Models in Stock
Starting at $95.00
Sixth Sense PG30 Paperless Recorder
Sixth Sense PG30 Paperless Recorder
Highly capable quality assurance instrument with 12.1in TFT display & up to 48 channels for sophisticated applications.
Starting at $3,600.00
MadgeTech AVS140-6 Temp / Pressure Data Logging System
MadgeTech AVS140-6 Temp / Pressure Data Logging System
Autoclave validation system data logger measures up to 500°F and 72 PSI using five HiTemp140 and one PR140 data loggers.
$5,299.00
Isotech Gemini 4857 Dry Block Calibrator
Isotech Gemini 4857 Dry Block Calibrator
Fixed or removable insert dry block temperature calibrators, range choice of 35 to 550ºC or 50 to 700ºC.
Starting at $6,080.38
MadgeTech AVS140-1 Temperature Data Logging System
MadgeTech AVS140-1 Temperature Data Logging System
Autoclave validation system data logger measures up to 500°F with memory for 32,700 readings.
$1,849.00
HOBO HOBOware Pro Software
HOBO HOBOware Pro Software
Plot or export data to spreadsheets, time saving tools to fast setup, readout and export, compatible with all HOBO data loggers.
In Stock
$99.00
Isotech Gallium Melt Point Cell
Isotech Gallium Melt Point Cell
ITS-90 Fixed Point, Gallium Melt Point Cell for ISOCAL 6.
$3,939.60
Isotech I-Cal Easy Calibration Software
Isotech I-Cal Easy Calibration Software
Powerful software automates the calibration process and provides certificates.
$5,193.94
Isotech Water Triple Point Cell
Isotech Water Triple Point Cell
ITS-90 fixed point, water triple point cell for ISOCAL 6, includes container and three caps.
$1,478.53