Information (see attachment) on
Best-Practice
Compliance
ERES-requirements of global regulation authorities
FDA 21 CFR Part 11
EU GMP Annex 11
ANVISA (Brazil) Resolution - RDC n. 17
PFSB/ELD Notification No. 0401022 of Japan
Current good manufacturing practise (CGMPS) for pharmaceuticals: risk-based
PIC/S-guidelines
ICH-guildeline (CH Q7A)
Chinese State Food and Drug Administration
Functions in beas industry solutions:
electronic records
table logs
date and time stamp
electronic signature - according to 21 CFR Part 11
quality of soft ware
SAP and beas life cycle management
good practice for supplier (GMP)
GAMPS5 - soft ware category 4 (configurable product)
validation for compliance
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