Is GMP Annex 11 Europe's answer to 21 CFR 11? January 2011 saw the publication of the new revision of European Union (EU) GMP Annex 11 on computerized systems and Chapter 4 on documentation. What will the impact be of these two revised regulations on computerized spectrometry systems operating in regulated GMP laboratories?
In: Spectroscopy, Jg. 26 (2011-04-01), Heft 4, S. 24-33
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Zugriff:
Titel: |
Is GMP Annex 11 Europe's answer to 21 CFR 11? January 2011 saw the publication of the new revision of European Union (EU) GMP Annex 11 on computerized systems and Chapter 4 on documentation. What will the impact be of these two revised regulations on computerized spectrometry systems operating in regulated GMP laboratories?
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Autor/in / Beteiligte Person: | McDowall, R.D. |
Link: | |
Zeitschrift: | Spectroscopy, Jg. 26 (2011-04-01), Heft 4, S. 24-33 |
Veröffentlichung: | 2011 |
Medientyp: | academicJournal |
ISSN: | 0887-6703 (print) |
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