Over twenty five (25) years of experience in validation, cGMP, quality engineering, process/mechanical design and software development [LabVIEW].
Projects range from small equipment qualification to long term contracts that provide validation, quality engineering and cGMP support for facility and process compliance.
Experience with computer system and automated system validation – supporting the entire life cycle: URS, FS, SDS, FAT, SAT, IQ, OQ, PQ.
CQE Services utilizes LabVIEW to develop custom applications for data acquisition, data analysis and other applications using various hardware and instrumentation to monitor and log critical parameters, such as cleanroom or storage environmental parameters (Eg, temperature, humidity, differential pressures, particle counts), process parameters, data from PLC’s or other hardware for custom test systems. Features such as alarming and email alerts can be included. SQL Server database interface can be utilized for data logging. Data analysis capabilities can be built in for retrieving, charting and statistical analysis. System development and validation can be provided along with all life cycle documentation.
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