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Article Series Continuous Improvement in a QMS: 3. Process Improvement Methodologies

Connecting the Dots in Continuous Improvement In our exploration of the 'fil rouge' that underlies key quality processes within a Quality Management System (QMS), we've embarked on a journey to understand how continuous improvement shapes the landscape of the...
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Article Series Continuous Improvement in a QMS – the Fil Rouge that Connects all Quality Processes:: 2.2 The Role of the Business Process Owner Within a QMS (Part 2)

  PART 2: What Should an Organization Look for When Assigning the Role of Business Process Owner Within the QMS? In PART 1 of this article, we talked about the key responsibilities of the QMS BPO and how these are grouped into four areas: the Process and its...
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Article Series Continuous Improvement in a QMS – the Fil Rouge that Connects all Quality Processes:: 2.1 The Role of the Business Process Owner Within a QMS (Part 1)

  PART 1: The Importance and Complexity of the Business Process Owner Role In recent years, the pharmaceutical industry has made substantial efforts to enhance understanding and define the role of the Business Process Owner (BPO) within the Quality Management...
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Avoid FDA Warning Letters in the Context of Computerized System Validation: A Short Guide by KVALITO

Photo by Eduardo Dutra on PexelsElevating Compliance in the Life Sciences: Navigating Computerized System Validation (CSV) In the ever-evolving life sciences domain, adherence to regulatory compliance is the cornerstone of operational integrity. Central to this...
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