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With the advent of a greener society, could anyone provide basic
guidelines for the archiving of electronic LC MS data, bearing in mind
that we are a small university based analytical laboratory?
We have, in the past, preferred to print out all chromatographic data,
but feel that this is no longer socially responsible.
Thanks.
Jennifer Norman
University of Cape Town
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HI
Simple way is
1. to buy an external hard disk and use windows backup tool to archive
the data.
2. copy all the folders to the external disk
3. University IT department will have a backup policy - check with
them as they can help you in backing up all the files/folders regularly.
Kind Regards
Chandramouli Radhakrishnan
moulirc.aaa.hotmail.com
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The following message was posted to: PharmPK
There are a lot of factors that would shape that discussion, including;
Is your work subject to any regulations ? GLP especially is quite
specific on what constitutes 'Archiving' and what standards need to
apply
How much data are we talking about ? 10 samples a day, 1,000 samples a
day ?
What do you want to archive ? Just the report from the end, or all of
the data and meta data ?
How much resource do you want to devote to this ?
The answers to these might help steer the discussion, until then here
are some references to regulations, articles and guidelines that might
also help;
Working group on Information technology (AGIT): Guidelines for the
archiving of electronic raw data in a GLP environment]. May 2003
OECD Series on Principles of Good Laboratory Practice and Compliance
Monitoring No. 1: OECD Principles of Good Laboratory Practice (as
revised in 1997). Environment Directorate, OECD, Paris, 1998
OECD Series on Principles of Good Laboratory Practice and Compliance
Monitoring No. 10: GLP Consensus Document. The Application of the
Principles of GLP to Computerised Systems. Environment Monograph No.
116; Environment Directorate, OECD, Paris, 1995
Electronic Records; Electronic Signatures; 21 CFR Part 11 (Rule 11), US
Food and Drug Administration, 20 March 1997
Guidance for industry - Part 11, Electronic Records; Electronic
Signatures - Scope and Application (Draft Guidance, February 2003)
Quality Assurance implications for computerised systems following the
Able laboratories FDA inspection (R. D. McDowell, UK). Qual Assur J
2006; 10,15-20
Regards,
Paul.
--
Paul Hurley
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