Twenty eight (28) years of experience in validation & compliance, quality engineering, process/mechanical design and software development.
Projects range from small equipment qualifications – supporting life cycle activities for new facility, expansions or new processes – or long term contracts for quality management system support, conformance audits, or improvement projects.
Customers served include, but not limited to, industry sectors of: Medical Device, Pharmaceutical, Ceramics, Temperature Logging/Monitoring Devices, Calibration labs, and Telecommunication fiber optic manufacturing.
Experience with computer system / automated system validation – Supporting the entire life cycle: URS, FS, SDS, FAT, SAT and qualification, including validation with respect to 21 CFR part 11.
CQE Services, LLC 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 (temperature, humidity, differential pressures, particle counts), process parameters, data from PLC’s or other hardware for custom test systems. Features such as trending, alarming and email alerts can be included. Data logging to SQL Server database, Access, spreadsheet, text files or binary data files. Data analysis capabilities can be built in for retrieving, charting and statistical analysis calculations. System development and validation can be provided along with all life cycle documentation.