计算机系统验证omcl,№8.OMCL指南：计算机化系统的验证（24页）-原创力文档

General European OMCL Network (GEON)

QUALITY MANAGEMENT DOCUMENT

PA/PH/OMCL (08) 69 R7

VALIDATION OF COMPUTERISED SYSTEMS

CORE DOCUMENT

Full document title Validation of Computerised Systems – Core document

and reference PA/PH/OMCL (08) 69 R7

Document type Guideline

Legislative basis -

Date of first adoption May 2009

Date of original entry July 2009

into force

Date of entry into August 2018

force of revised

document

Previous titles/other PA/PH/OMCL (08) 69 3R

references / last valid

version

Custodian The present document was elaborated by the OMCL Network /

Organisation EDQM of the Council of Europe

Concerned Network GEON

PA/PH/OMCL (08) 69 R7 – Validation of Computerised Systems – Core document

VALIDATION OF COMPUTERISED SYSTEMS

CORE DOCUMENT

Note: Mandatory requirements in this guideline and its annexes are defined using the terms

«shall» or «must». The use of «should» indicates a recommendation. For these parts of the text

other appropriately justified approaches are acceptable. The term «can» indicates a possibility or

an example with non-binding character.

1. SCOPE

This guideline defines basic principles for the validation of computerised systems used within

Official Medicines Control Laboratories (OMCLs) and having impact on the quality of results,

document control and data storage [1]. The purpose of this validation is to guarantee confidence in

the laboratory data captured, processed, reported or stored by computerised systems. A validated

system ensures accurate results and reduces any risks to data integrity.

This document applies to all types of computerised systems used in OMCLs. Howeve