Caltek now provides at client’s premise/ On-Site IQ/OQ/PQ Installation, Operation and Performance Qualification) and other validation processes. Our Team of Qualified and Trained Engineers and Consultants will be able to assist on the Standard Protocols, perform Data Analysis and Generate the Report. Our Consultants will make recommendations based on the worse-case and normal operating conditions, future performance qualification and on-going maintenance of the equipment. Our On-Site Team is available on standby for On-Site Qualification.
Mapping data reports are GAMP (Good Automated Manufacturing Practices) Compliant and FDA 21 Part 11, which “applies to records in electronic form that are created, modified, maintained, archived, retrieved or transmitted under any records requirements set forth in Agency regulations”. The Reference Data logging devices are calibrated by our Accredited Laboratory which is Traceable to SI units realized by National Standards, NMC and other International Standard Laboratories.