This document introduces the Varian Star Chromatography Workstation Version 6 Regulatory Compliance Manual, including product development procedures, software installation validation, data documentation and logs.
This document serves as a Regulatory Compliance Manual for the Varian/Agilent Star Chromatography Workstation, Version 6. It outlines how the software was designed, developed, and tested to meet quality engineering practices such as Good Laboratory Practice (GLP), Good Automated Laboratory Practice (GALP), and ISO 9001 standards.
The purpose is to help users comply with regulations such as Good Laboratory Practice (GLP), Good Automated Laboratory Practice (GALP), and ISO 9000.
Compliance is strictly the responsibility of the instrument user, not Varian.
The company holds an ISO 9001 certification.