FDA's 21 CFR Part11 and EPA Compliance

All Shimadzu network system products incorporate functions for the Part 11 compliance and computer validation functions required by GxP. Shimadzu provides documentation including IQ/OQ, Certificates of Compliance, and Inspection Test Result Reports based on Shimadzu ISO9001 certified system.
Shimadzu's accredited service personnel offer full support for validation of customer's Shimadzu products. Shimadzu provides comprehensive customer support for FDA compliance, including supplying the latest information on FDA regulations through seminars and workshops, participating in vendor audits demanded by the Agency, and actively assisting customers to comply with new FDA regulations.

Shimadzu HPLC, GC, Mass Spectrometers, UV-VIS spectrophotometers, FTIR, AA, TOC and other products and their associated data processing systems all incorporate sophisticated, leading-edge technology for audit trail, security, and Data integrity functions to comply with GLP and cGMP demands.
In addition to offering products and network-compatible software products, Shimadzu offers total support for creating system operation and management procedures, provides information, organizes seminars, and offers post-installation training on Part 11.