Product category:
Detectors, sensors and probes
News Release from: Barber InSys | Subject: Opus 300i
Edited by the Laboratorytalk Editorial
Team on 09 April 2003
Measuring and control to 21 CFR Part 11
Data acquisition system developed and implemented in cooperation with pharmaceutical manufacturers in order to comply with the requirements of the FDA regulation
The 21 CFR 11 issued in 1997 contains the necessary requirements about the use of electronic data collection as well as the conversion of electronic records and electronic signatures to comply with FDA requirements The ideal solution for measuring and controlling equipment to comply with this requirement is a modular system whose component parts (sensor, datalogger, and software) are qualified individually, so that a system based on a modular principle is qualified as a whole
This article was originally published on Laboratorytalk on 10 Jan 2003 at 8.00am (UK)
Related stories
New technology at nice price from thermometer
The ASL F200 Precision thermometer monitors and records any out of range temperatures so you can see at a glance if the probe has been misused
Thermal detection of Sars suspects
Non intrusive thermal detection system enables health officials to detect persons with raised body temperature at ports, airports and other public gatherings
The Lufft data acquisition system Opus 300i has been developed and implemented in cooperation with pharmaceutical manufacturers in order to comply with the requirements mentioned above.
User requirement specifications (customer) and manufacturer requirement specifications (Lufft) are issued based on customer needs.
The release of the so called manufacturer requirement specifications by the customer leads to the design qualification (DQ).
While installing the system, the installation qualification (IQ) is taking place.
Operation qualification and performance qualification (PQ) follow.
Lufft's accredited laboratory for temperature, relative humidity and pressure, enable them to provide accurate and traceable instrumentation.
With an extensive sensor range combined with a flexible data acquisition (modular structure Opus 300i) alarm settings and SmartControl software protected by password for any user levels, enable the GMP requirements to be met.
• Barber InSys: contact details and other news
• Email this article to a colleague
• Register for the free Laboratorytalk email newsletter
• Laboratorytalk Home Page
Search the Pro-Talk network of sites
