Shimadzu Total Solution for PIC/S and FDA Compliance

Network System to Regulatory 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 HPLC, GC, Mass Spectrometers, UV-VIS spectrophotometers and other spectroscopy products and their associated data processing systems all incorporate sophisticated, leading-edge technology for Access control, Audit trail, and Protection and Security of data functions to comply with regulatory demands. In addition to offering instrumentation and network-compatible software, Shimadzu offers total support for creating system control and management procedures, provides information, organizes seminars, and offers post-installation training on PIC/S GMP and Part 11.

PIC/S refers to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme.PIC/S devises and promotes harmonious GMP standards and quality systems for the inspection of medical supplies.
There are currently 44 members of PIC/S, including agencies from theUnited States and EU countries. Japan, South Korea and other countries have applied for affiliation, while China and Russia show interest in being affiliated. PIC/S PIC/S is a private agreement between the regulatory agencies of each member nation. The affiliated member is the agency or authority responsible for inspecting pharmaceutical companies. Activities include the training of inspectors, the networking of the affiliation inspection authorities, and the evaluation of GMP inspection. PIC/S does not inspect a pharmaceutical company directly.

It is thought that the GMP standards published by PIC/S will become internationally accepted.

Shimadzu's Response for Regulatory Compliance

Shimadzu's basic policy is to comply with regulations by integrating data management for all instruments used in the laboratory, including chromatographs and mass spectrometers (HPLC, GC, LC-MS, GC-MS), spectrophotometers (UV, FTIR etc.), total organic carbon analyzers (TOC), thermal analyzers, and balances.
Shimadzu's LabSolutions/CLASS-Agent products provide solutions for the regulatory compliance of all essential laboratory analysis data from chromatographs and spectrophotometers to balances. Shimadzu supports networking for all analytical instruments to enhance workflow efficiency and data reliability.

Guidance for Industry: Part 11 Validation (draft 9/20/2001)

Computer systems must be validated according to an appropriate procedure to
ensure the reliability of electronic records and electronic signatures. This draft guidance indicates the current FDA philosophy on computer validation and provides important guidance for implementing Part 11 compliance.

In addition to the functions required for compliance with all regulations including Part 11, the FDA has added basic requirements for the computer system itself such as the number of clients connected to the network, disk capacity, network expandability, etc. When creating specification requirements, it is important to confirm such basic information in addition to standard regulatory items.

Key Points

  • Confirm the specification requirements.
  • It is important that the specification requirements meet the demands on the system and operating environment, and also incorporate the technical elements to satisfy Part 11.
  • The documentation of plans, procedures, and reports and appropriate review, approval, and management.

For Research Use Only. Not for use in diagnostic procedures.

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