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GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)

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Standard for Automatic Trailer Fill Compliance to 21 CFR Part 11 and PIC/S Annex 11 Requirements
Handbook / Manual / Guide by Compressed Gas Association, 03/01/2016

Description

TThis publication provides the guidance for meeting electronic record/ electronic signature regulatory requirements for automatic trailer fill systems and records, including trailers, microbulk vessels, railcars, and ISO containers at bulk medical gas and bulk food gas manufacturing facilities.

This publication does not cover the filling of compressed gas cylinders or small cryogenic containers.