News
from EDQM: Since the adoption of the first version of the “Validation of
Computerised Systems” guideline in May 2009, most of the Network members have
introduced computerised systems e.g. Laboratory Information Management Systems
(LIMS) and electronic document management systems into their labs which have
become commonly used working tools of the Network. For that reason and also
based on experiences gained during Mutual Joint Audits, the guideline has been
profoundly restructured and revised.
The
scope for new core document states:
“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. 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. However, depending on
their complexity, the extent of testing and documentation will differ.
Computerised systems can be categorised into three types: exempted, simple and
complex (see table I in section 3). This document describes a scalable
validation approach for simple and complex computerised systems.”
The
revised version is now organised in a core document and two annexes (instead of
three annexes in the previous version). All three parts of the guideline will
come into force on 1 August 2018.
Posted by Dr. Tim Sandle
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