FDA Warning Letter - Alarm Management

Date: 25 May 11
Link FDA 483 (PDF - New Window)

Observation
b. During routine operations, if there is an alarm event (e.g., time out, high and low temperature for washing and siliconizing, instrument line failure, jacket gauge failure and steam header failure) during the wash and depyrogenation process, the [redacted] Stopper Washer captures the alarm condition via a print out and the data is

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EU Annex 11 - Computer System Inventory

EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines Annex 11 for computerised systems includes the requirement for the regulated company to maintain an up to date listing of relevant systems (GMP Computerised Systems) and their GMP functionality (inventory).

This is also a Japanese regulatory requirement and also an expectation of the FDA although not included within the

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