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New GAMP SIG Explores Computer Software Assurance

Charlie C. Wakeham
New GAMP SIG Explores Computer Software Assurance

ISPE GAMP® has led the way in computerized systems best practices for more than 30 years. GAMP brought us the concept of system lifecycles and leveraged the V-model to give us a structured approach to computerized systems validation (CSV). GAMP developed and adopted the risk-based approach to CSV, enabling industry to focus validation efforts on critical systems and functionality.

Now, GAMP has formed the Global Computer Software Assurance Special Interest Group (GAMP CSA SIG) to empower industry to use CSA and critical thinking within the GAMP computerized system validation paradigm to maximize validation efficiency and fitness for intended use.

GAMP 5 2nd Edition Coming Soon

The objective of this SIG is to help shape the application of CSA based on GAMP principles and the practical CSV experience of ISPE members; this global SIG will help foster and guide local CSA discussions and provide consistent global messaging.

The SIG leaders are:

Charlie C. Wakeham
WakeUp To Quality
Khaled Moussally
Executive Vice President Clients & Regulatory Relations
Compliance Group Inc
Fellow Software Quality Engineer
Boston Scientific
Ken Shitamoto
Executive Director, IT - Quality and Compliance
Gilead Sciences
Francisco Vicenty
Program Manager, Case for Quality

The first online meeting of the SIG is on Tuesday 12 July at 12pm EST / 5pm BST / 6pm CEST. During this meeting, you will meet the SIG leaders and hear first-hand from Francisco Vicenty (FDA Case for Quality Program Manager) about his vision for CSA.

As an ISPE member, it is easy and free for you to join this SIG:

  • Go to log in to your ISPE account.
  • Go to My Account > My Interests and Communities.
  • In the Communities of Practice list, check the box next to “GAMP Computer Software Assurance Special Interest Group” and save your changes.
  • You will now be able to access the new GAMP CSA SIG site.
  • GAMP CSA SIG news and SIG meeting invitations will be posted into the SIG site. Members are welcome to post questions and comments but please note commercial content is prohibited.

The GAMP CSA SIG will meet online every 2-3 months at 11am EST, sharing practical approaches and real-life experiences. The SIG will dispel all the myths and misunderstanding around CSA, and promote open discussion of challenges and solutions.

Learn More & Join