Bulletin Board

Are you leveraging a risk-based approach when validating your GxP computerized systems?
Attend the 19-21 March new Basic Principles of Computerized System Compliance using GAMP® 5, Including Revised Annex 11 and Part 11 Update 3-day course in San Diego, CA that was developed and taught by a member of the ISPE GAMP COP.  Register now.

GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) Read More.

 

About the GAMP COP

ISPE’s GAMP Community of Practice is comprised of like-minded professionals from around the world collaborating and interacting to address issues of common concern. The GAMP COP is governed by a Steering Committee of committed Volunteers who are subject matter experts in diverse fields.

Download the GAMP COP Brochure ( 384 KB)


 

COP Mission

The GAMP® COP exists to promote the understanding of the regulation and use of computer systems, control systems, and intelligent instruments (also called "computer systems") within the pharmaceutical, biopharmaceutical, or medical device company.


 

How to Get Involved

As a GAMP COP member you can access technical discussions or download presentations or files. You can complete a volunteer profile and share your expertise with the community. Note that only ISPE Members can engage in these activities.

Community Discussions

  • Raw material supplier and validation of DCS
    GAMP, 17 May, (5 comments)
    A raw material supplier to us is changing their DCS system and is looking to us for guidance on its ... Continue reading
  • How to identify a computerized system?
    GAMP, 26 April, (5 comments)
    According to "EU GMP - GLOSSARY", a computerized system is defined as follow: A system including th ... Continue reading
  • GAMP Practice for Process Controls, GEP and Medical Device industry
    GAMP, 23 April, (3 comments)
    Hello, I am currently looking to integrate Qualification of Process controls lifecycle approach a ... Continue reading
  • GAMP and medical devices
    GAMP, 22 April, (6 comments)
    Can anyone tell me if GAMP guidelines include software under the EU Medical Device Directive. Reg ... Continue reading
  • Verification of regulatory data copied on media
    GAMP, 16 April, (3 comments)
    Hi everybody, What kind of tools are you using for verification of regulatory data that is being ... Continue reading