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.
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.
