Mind the GAP
Mind the GAP
A new, adaptable QMS offers a common standard for all disciplines
- Publication:
- Quality Progress
- Date:
- November 2020
- Issue:
- Volume 53 Issue 11
- Pages:
- pp. 30-37
- Author(s):
- London, Calvin, Comeros, Reyna Chris, Nguyen, An
- Organization(s):
- Compliance Concierge, Beaumaris, Australia, Celgene Pty. Ltd., Southbank, Australia, Celgene Pty. Ltd., Southbank, Australia
Abstract
Many quality management system (QMS) standards and guidelines do not address the requirements of healthcare compliance or supporting business functions. So, the authors established an adaptable QMS called good affiliate practices (GAP). GAP offers a shared, common standard that complies with global minimum affiliate requirements and compliance, and QMS requirements that fall outside the typical realms of good manufacturing practices. The GAP system is based on five critical components that represent common key elements of a QMS: document management, training, excursion and corrective and preventive actions, management review and internal review.
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