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! !"#$%&'"() ! 21 CFR 11 !"#$%&'()*+,- !"#!"#$%&' !"#$%&'()* !"#$% www.biopharm- mag.com !"# !" !" Regulatory Issues Ludwig Huber and Rory Budihandojo Ludwig Huber is worldwide product manager for pharmaceutical solutions at Agilent Technologies GmbH, PO Box 1280 D-76337, Waldbronn, Germany, +49.7243.602.209, fax +49.7243.602.501, [email protected], www.agilent.com. Rory Budihandojo is head of R&D for IT quality and testing at the Centre of Excellence, GlaxoSmithKline, Collegeville, PA 19426. !"#!" !"#$%&'()* !"#$%!"#$% !"!"#$%&'( !"#$%&'()*+ ! 1 !"#$%&' !"!#$%&'()FDA !"#$%&'(! !"#$%&'()*+,- !"#$%&'!"# !"#$%&'(!" !"#$%&'!"# !"#$%&'()*+,- !"#$%&'()*+, !"#$!"#$%& !"#$%&'()*+,-. !"#$%&'( ! ! ! !"#$!"#$%& !"#$%&'()*+,- !"1 !"#$%&'( !"#$%&'!"# !"#$#%&' 2 ! ! Crosson, Campbell Noonan !"#$%&'!"# !"!"#$%&'() !"#$%3 !" Olthof ECA 4 !"# ! IT ! ! !"# GAMP !" !"#$%&'()*+ IT !"#$%&'(!) !"#$%&'(!)* !"# IT !"#$% !"#$ !"#$ !"#$%&'()*+ !"#!"#$%&' ! !"#$%&'($)*+ !"#$%FDA (www. fda.gov) GAMP (www.gamp. org) PDA (www.pda.org) !"# www.labcompliance. com www.computervalidation. com!"#$%&'()* !"#$%&!"#$ !"#$%&'(! !"#$% FDA FDA !"#$%&!" !"#$%483s !"# !"#$%&#'()*+, !"#$%!"#$% FDA !"#$%&'() !"#$%!"#$% FDA !"#$%&'() !"#$%&'()*"+, !"#$%&'()*+, !"#$%&!"#$ !"#$%&'( !"#$%&'( / ! 1985 !"#$% ... !" !"#$%& !"#$%&

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Page 1: Chemical Analysis, Life Sciences, and Diagnostics | Agilent · Validation Plan Design Qualification • Check complete arrival as purchased • Check correct installation of computer

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Regulatory Issues

Ludwig Huber andRory Budihandojo

Ludwig Huber is worldwide product manager for

pharmaceutical solutions at Agilent Technologies

GmbH, PO Box 1280 D-76337, Waldbronn,

Germany, +49.7243.602.209,

fax +49.7243.602.501, [email protected],

www.agilent.com. Rory Budihandojo is head of

R&D for IT quality and testing at the Centre of

Excellence, GlaxoSmithKline, Collegeville, PA

19426.

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Page 3: Chemical Analysis, Life Sciences, and Diagnostics | Agilent · Validation Plan Design Qualification • Check complete arrival as purchased • Check correct installation of computer

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��

�� ! (1) L. Huber, Validation of Computerized

Analytical Instruments (Interpharm Press, Inc.,Buffalo Grove, IL, May 1995).

(2) N. Jenkins and S. Schatt, Understanding LocalArea Networks: Easy Introduction to NetworkConcepts and Products (SAMS Publishing,Indianapolis, 1998).

(3) J.E. Crosson, M.W. Campbell, and T. Noonan,“Network Management in an FDA-RegulatedEnvironment,” PDA Journal 53(6), 280–286(1999).

(4) H. Olthof, “GXP Requirements for ITInfrastructure,” presented at the ECAconference: FDA 21 CFR Part 11 Compliancefor Pharmaceutical Laboratories (EuropeanCompliance Academy, Copenhagen,Denmark), October 2000.

(5) IT Infrastructure Special Interest Group,Quality Assurance (GAMP, Tampa, FL, 2000),draft document.

(6) J.C. Famulare, Warning Letter #320-01-08(Center for Drug Evaluation and Research,11 January 2001). Available atwww.fda.gov/foi/warning_letters/m5056n.pdf.

(7) J.C. Famulare, Warning Letter #320-01-07(Center for Drug Evaluation and Research,11 January 2001). Available at www.fda.gov/foi/warning_letters/m5057n.pdf.

(8) “FDA 483 Observations Related to IT”(Labcompliance, July 2000). Available atwww.labcompliance.com/publications/lit-references.htm.

(9) “FDA 483 Inspectional Observations andWarning Letters Related to Computers”(Labcompliance web site). Available atwww.labcompliance.com/computer/fda-observations.htm.

(10) Code of Federal Regulations, Food and Drugs,“Electronic Records; Electronic Signatures,”Title 21, Part 11 (U.S. Government PrintingOffice, Washington DC), issued March 2000.Also Federal Register 62(54), 13429–13466.Available at www.fda.gov/ora/compliance_ref/part11. BP

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