Cooperative Systems in chemical industry:
GMP compliant handling of raw data in the environment of chemical analytics
Dr. Jan Hauß
Merck KGaA Darmstadt
Germany
Post-box 64271 Darmstadt
Frankfurter Straße 250
64293 Darmstadt
Jan.Hauss@Merck.de
The handling of raw data becomes an intriguingly interesting problem for
the pharmaceutical industry as well as for the scientific community. Due to
some restrains in the legal environment (21 CFR Part 11[1],OECD [2]) and
limited resources for fulfilling the requirements resulting from these
restrains, a three tier client server model program (Q~DIS/R) was
implemented. The design overcomes common problems with archiving and
retrieving data from validated sources. Storage of data is media
independent. Data formats are human-readable and implemented in open
formats (e.g. JACMP-DX ). Security, authenticity and integrity of the data
is guarantied, the validity of the data is verified through an audit-trail
and strong security measures.
The system is prepared for electronic signature compliant to the advanced
electronic signature described by the (EU-directive [3]).
The system is by design high available and does not require the use of
special H.A. (operating system) software for this function. The user and
device frontends are implemented in JAVA and are platform independent. Thus
almost any computer and measurement device attached to it can be
integrated. Users and administrators enjoy the ease of use of web-based
environments.
[1] Federal Register March 20, 1997 (62 FR 13430), (21 CFR part 11)
[2] OCDE/GD(95)115 OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE
AND COMPLIANCE MONITORING NUMBER 10 GLP CONSENSUS DOCUMENT THE APPLICATION
OF THE PRINCIPLES OF GLP TO COMPUTERISED SYSTEMS ENVIRONMENT MONOGRAPH NO.
116 ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT Paris 1995
[3] RICHTLINIE 1999/93/EG DES EUROPÄISCHEN PARLAMENTS UND DES RATES vom
13.Dezember 1999 über gemeinschaftliche Rahmenbedingungen für elektronische
Signaturen, Amtsblatt der Europäischen Gemeinschaften, 19.1.2000 [DE] L
13/12-20
[4] Official Journal of the European Communituies, C 243/33, COMMON
POSITION (EC) NO 28/1999
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