Does anyone have any more information on what,
'F 1.2 Examination procedures shall be validated for their intended use
prior to introduction, and the methods used and results obtained, recorded.'
means in practice? ie what level of documentation of validation is
sufficient for an assay, do we need to demonstrate linearity, precision,
etc. and the provenance of our normal ranges for each analyte we provide?
Does this extend to the clinical purpose for which the assay is used by our
'customers'? And is it all liable for inspection? I'm sure all of us have
this data within the laboratory but not necessarily to hand in a single
source.
I'm trying to get some idea of what level of detail will be needed for
compliance with this standard.
Any thoughts?
Ian Mc
_________________________________________________________________
Send and receive Hotmail on your mobile device: http://mobile.msn.com
------ACB discussion List Information--------
This is an open discussion list for the academic and clinical
community working in clinical biochemistry.
Please note, archived messages are public and can be viewed
via the internet. Views expressed are those of the individual and
they are responsible for all message content.
ACB Web Site
http://www.acb.org.uk
List Archives
http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html
List Instructions (How to leave etc.)
http://www.jiscmail.ac.uk/
|