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CGA M-16

$17.00

Standard for Food, Drug, and Medical Device Gas and Gas Equipment Manufacturers on Electronic Records and Signatures
Handbook / Manual / Guide by Compressed Gas Association, 02/23/2022

Format: PDF

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    Category:

    Description

    This publication is based on 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 electronic records, electronic signatures, and handwritten signatures executed to electronic 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).

    Product Details

    Edition:
    2
    Published:
    02/23/2022
    Number of Pages:
    16
    File Size:
    1 file , 380 KB
    Note:
    This product is unavailable in Belarus, Russia, Ukraine
    Sale!

    CGA M-16

    $15.50

    Guidance for Electronic Records and Signatures in the U.S. and Canadian Food, Drug, and Medical Device Gas and Gas Equipment Industry
    Handbook / Manual / Guide by Compressed Gas Association, 03/01/2016

    Format: PDF

      GUARANTEED SAFE CHECKOUT
      Category:

      Description

      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).

      Product Details

      Edition:
      1st
      Published:
      03/01/2016
      Number of Pages:
      16
      File Size:
      1 file , 260 KB