• CGA M-16

CGA M-16

  • Guidance for Electronic Records and Signatures in the U.S. and Canadian Food, Drug, and Medical Device Gas and Gas Equipment Ind
  • Handbook / Manual / Guide by Compressed Gas Association, 03/01/2
  • Category: CGA

$31.00 $16.00

This guideline is based upon FDA's August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and Application and satisfies the criteria of 21 CFR Part 11, § 11.1 (a) "The regulations in this part set forth the criteria under which the agency considers e-records, e-signatures, and handwritten signatures executed to e-records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper".
This guideline also harmonizes with PIC/S Guide for good manufacturing practice for medicinal products, Annex 11 "Computerised Systems" (as adopted in Canada).
PDF

All of our standards document are available in PDF (Portable Document Format), an electronic, downloadable format.You will be able to download the file in your account downloads.

Multi-User Access

After purchasing, you have the ability to assign each license to a specific user.

Printable

At any time, you are permitted to make printed copies for your and your members' reference use.

CGA C-27

CGA C-27

Standard Procedure to Derate the Service Pressure of DOT 3-Series Seamless Steel Tubes..

$9.00 $17.00

CGA V-21

CGA V-21

Torque Guidelines for Sealing CGA Valve Outlet Connections (Formerly TB-14)..

$11.00 $13.00

CGA M-1.1

CGA M-1.1

Guidance for Compressed Medical Gas Cryogenic Fluid Central Supply System Training..

$9.00 $17.00

CGA PS-55

CGA PS-55

CGA Position Statement on Use of Nonsparking Tools..

$3.00 $5.00