Utilizing GAMP® 5 Second Edition

𝐂𝐨𝐧𝐭𝐢𝐧𝐮𝐨𝐮𝐬 𝐈𝐦𝐩𝐫𝐨𝐯𝐞𝐦𝐞𝐧𝐭: GAMP® 5 Second Edition provides organizations with a roadmap to help define the path to success, but leaves many areas open for interpretation on how to manifest a complete compliance program most effectively.

𝐈𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐢𝐧𝐠 𝐓𝐫𝐚𝐢𝐧𝐢𝐧𝐠: A system may not be used by untrained resources, making the training program a key element in orchestrating a successful rollout, according to the rollout plan. The manifestation of hands-on training sessions and/or applicable “read and understand” training programs, coupled with the development of training materials, ensures alignment…

𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐓𝐞𝐬𝐭𝐢𝐧𝐠: The Validation plan provides guidance on the level of rigor with the validation, and what documentation is required. The Validation Plan also identifies the organizational roles that are responsible for validation activities.