Description

This 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.

Product Details

Edition:

1st

Published:

03/01/2016

Number of Pages:

12

File Size:

1 file , 260 KB

Note:

This product is unavailable in Russia, Ukraine, Belarus

Description

CGA M-17 – Standard for Automatic Trailer Fill Compliance to 21 CFR Part 11 and PIC/S Annex 11 Requirements

This publication applies to ATF systems and records, including trailers, microbulk vessels, railcars, and ISO containers at bulk medical gas and bulk food gas manufacturing facilities.

In addition to the guidance in this publication, see CGA M-27, Guideline for Complying with Data Integrity Regulatory Expectations, for more information on compliance with data integrity requirements for ATF systems [3].

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

Product Details

Edition:

2

Published:

02/23/2022

Number of Pages:

12

File Size:

1 file , 380 KB

Note:

This product is unavailable in Russia, Ukraine, Belarus