Page 3 - Pharmaceutical-Shimadzu Total Solution PICS & FDA Compliance

SHIMADZU presents Part 11 Compliant Network System
Network System
Network System
PIC/S GMP/FDA 21 CFR Part 11/Computerized Validation Total Solution
Software and other products provide the functions
required for FDA compliance.
All Shimadzu network system products incorporate functions for the PIC/S GMP and the Part 11 compliance
regulation, and computerized validation functions required by GxP. Shimadzu provides documentation including Validation Support
Data Processing Workstations and network systems
IQ/OQ, Certificates of Compliance, and Inspection Test Result Reports based on Shimadzu IS09001 certified system. Validation Support
for meeting PIC/S GMP and Part 11 demands
Shimadzu's accredited service personnel offer full support for validation of customer's Shimadzu products. In Support for creating system control and Systematic validation support for creating system operation and
addition, Shimadzu provides comprehensive customer support for PIC/S and FDA compliance, including supplying management procedures management procedures required for FDA compliance
On-site/off-site user training
the latest information on PIC/S and FDA regulations through seminars and workshops, participating in vendor
Providing DQ templates
audits demanded by agencies, and actively assisting customers to comply with new regulations.
IQ/OQ computer validation
Accredited service support

HPLC
HPLC
HPLC
HPLC
MS
MS

GCGC
TOC

Balance UV

Vendor Audit
Shimadzu Total Solution
Vendor Audit
for PIC/S GMP, FDA 21 CFR Part 11 FTIR Vendor audits based on extensive
and worldwide experience
and Computerized
ISO-9001 certified quality control system
Other Validation FDA Latest Information Supply of documentation, including Certificates
vendor’s of Compliance and Inspection Test Result Reports
instruments Latest Information
Reliability and Security Timely issuing and supply of the latest information
on FDA regulations and guidelines

Contracted FDA regulation consultants supply the latest
information and provide technical instruction
Shimadzu actively participates in FDA seminars
along with ISPE, PDA, and other organizations