GB/T 22275.6-2008Requirements of conduct for Good Laboratory Practice (GLP) -- Part 6: The application of the principles of GLP to computerised systems (English PDF)

Foreword

GB/T 22275 "to implement the requirements of Good Laboratory Practice" is divided into seven sections.

--- Part 1. Quality Assurance and Good Laboratory Practice;

--- Part 2. Good Laboratory Practice Research project leader roles and responsibilities;

--- Part 3. Laboratory Supplier of Good Laboratory Practice Principles compliance;

--- Part 4. Good Laboratory Practice principles in the field of applied research;

--- Part 5. Application of the principles of Good Laboratory Practice in short term studies;

--- Part 6. Application of the principles of Good Laboratory Practice in the computerized system;

--- Part 7. application of the principles of good laboratory practice in the organization and management of multi-site studies.

This section GB/T Part of 622,275.

This section is equivalent to using the Organisation for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and a series of documents for compliance monitoring no. 10. "GLP principles computerized system application" [OCDE/GD (95) 115].

This part of the editorial changes as follows.

--- Remove the foreword and introduction of the original;

--- Remove the original definition Note 1.

Appendix A of this section is an informative annex.

This part of the National Chemicals Management Standardization Technical Committee dangerous (SAC/TC251) and focal points.

The drafting of this section. Shandong CIQ, the Dangerous Chemicals Management Standardization Technical Committee.

1 Scope

This section GB/T 22275 specifies the application and management of GLP principles under the computerized system, including the responsibilities of various departments, phase Requirements related to training, equipment and instruments, computerized system maintenance and disaster recovery, the recording and processing of data, computerized system Safety, computerized system validation procedures, on their development, validation, operation and maintenance documentation requirements.

This section applies to applications under GLP principles computerized system.

2 Normative references

The following documents contain provisions which, through reference GB/T 22275 in this section constitute provisions of this section. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

GB/T 19001 Quality Management System Requirements GB/T 22278 principles of Good Laboratory Practice

3 Terms and Definitions

GB/T 22278 in the terms and definitions apply to this section.

4 Requirements

5 GLP Principle in computerized systems

The following considerations mentioned above, will be referred to the application of the principles of GLP in the computerized system to help.