Page 4 - Pharmaceutical-Shimadzu Total Solution PICS & FDA Compliance

Shimadzu Global Resources Provide

Local Support for PIC/S and FDA Compliance

Shimadzu Total Support for PIC/S GMP and Part 11 Compliance Shimadzu's Response for Regulatory Compliance

Shimadzu HPLC, GC, Mass Spectrometers, UV-VIS spectrophotometers and In addition to offering instrumentation and network-compatible software, Shimadzu's basic policy is to comply with regulations by integrating data Shimadzu's LabSolutions/CLASS-Agent products provide solutions for the
other spectroscopy products and their associated data processing systems all Shimadzu offers total support for creating system control and management management for all instruments used in the laboratory, including regulatory compliance of all essential laboratory analysis data from
incorporate sophisticated, leading-edge technology for Access control, procedures, provides information, organizes seminars, and offers chromatographs and mass spectrometers (HPLC, GC, LC-MS, GC-MS), chromatographs and spectrophotometers to balances. Shimadzu supports
Audit trail, and Protection and Security of data functions to comply with post-installation training on PIC/S GMP and Part 11. spectrophotometers (UV, FTIR etc.), total organic carbon analyzers (TOC), networking for all analytical instruments to enhance workflow efficiency and
regulatory demands. thermal analyzers, and balances. data reliability.

Shimadzu regulatory compliance network systems ensure data reliability,

Support for customers support audit trail, security, and data integrity
Compilation of the latest to create Part 11
information on Part 11 1 2 3
related SOPs
Total data management "Multi Data Report" makes Total support for
with LabSolutions/CLASS-Agent regulatory compliance easier regulatory compliance
Shimadzu total support extends beyond
Part 11 compliant data Shimadzu Part 11 compliant system Total management of Shimadzu and Access control and audit trail products to include assistance in creating system
other products
for report
processing systems / network Part 11 operation and control control and management procedures.
products Compliance procedures
Integrated Management of Analytical Data by LabSolutions/CLASS-Agent
Server LC GC LCMS GCMS TOC Office
Part 11 related Integrated Management Data search, re-analysis,
Seminars on Part 11 of Analytical Data approval and electronic
training courses signature

DB
LabSolutions/CLASS-Agent

Other vendor’s instrument Thermal analyzer AA UV FTIR Balance

PIC/S Guidance for Industry: Part 11 Validation (draft 9/20/2001)
PIC/S refers to the Pharmaceutical Inspection Convention and Pharmaceutical PIC/S is a private agreement between the regulatory agencies of each member Computer systems must be validated according to an appropriate procedure to including Part 11, the FDA has added basic requirements for the computer
Inspection Co-operation Scheme. PIC/S devises and promotes harmonious GMP nation. The affiliated member is the agency or authority responsible for inspecting ensure the reliability of electronic records and electronic signatures. This draft system itself such as the number of clients connected to the network, disk
standards and quality systems for the inspection of medical supplies. pharmaceutical companies. Activities include the training of inspectors, the guidance indicates the current FDA philosophy on computer validation and capacity, network expandability, etc. When creating specification requirements,
networking of the affiliation inspection authorities, and the evaluation of GMP provides important guidance for implementing Part 11 compliance. it is important to confirm such basic information in addition to standard
There are currently 44 members of PIC/S, including agencies from the United inspection. PIC/S does not inspect a pharmaceutical company directly. In addition to the functions required for compliance with all regulations regulatory items.
States and EU countries. Japan, South Korea and other countries have applied for It is thought that the GMP standards published by PIC/S will become
affiliation, while China and Russia show interest in being affiliated. internationally accepted. Key Points
• Confirm the specification requirements. • The documentation of plans, procedures, and reports and appropriate review,
• It is important that the specification requirements meet the demands on the approval, and management.
system and operating environment, and also incorporate the technical
elements to satisfy Part 11.

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