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      • OOS and OOT
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QMS

Digital QMS and PQR_ Top Integration Questions Answered
QMS
Digital QMS and PQR: Top Integration Questions Answered

Digitization is changing how pharmaceutical companies manage Product Quality Reviews (PQRs). With automated data capture, dashboards, and real-time trend tracking, digital QMS platforms promise efficiency — but also raise new questions for QA leaders.  Here are the top questions asked […]

by QEdge Team

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October 10, 2025
Best QMS | Quality Management System in 2025. What Pharma and Biotech Leaders Should Look For
QMS  ·  Quality Management 
Best QMS in 2025: What Pharma and Biotech Leaders Should Look For

In the highly regulated world of pharma and biotech, a robust Quality Management System (QMS) isn’t just a tool — it’s a strategic necessity. As we step into 2025, the stakes for compliance, efficiency, and innovation are higher than ever. […]

by QEdge Team

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May 7, 2025
The Future of Manufacturing Why Digital QMS Software is No Longer Optional
QMS
The Future of Manufacturing: Why Digital QMS Software is No Longer Optional

Why Digital QMS Software is the Future of Manufacturing  Manufacturing is evolving at an unprecedented pace. With increasing regulatory requirements, rising quality standards, and the push for automation, relying on outdated, paper-based quality management systems is no longer viable. Digital […]

by QEdge Team

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March 4, 2025
The Role of QMS Software in Preventing Repetitive Deviations in Pharma Manufacturing
QMS
The Role of QMS Software in Preventing Repetitive Deviations in Pharma Manufacturing

How QMS Software Helps Prevent Repetitive Deviations in Pharma Manufacturing  In pharmaceutical manufacturing, deviations are an unavoidable reality. However, when the same deviations occur repeatedly, they signal deeper systemic issues—often stemming from poor root cause analysis, ineffective corrective actions, or […]

by QEdge Team

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March 4, 2025
Regulatory Guidelines Pharma
QMS  ·  Risk based software validation
The Impact of Pharma PQR Software on Quality Assurance and Risk Management

How Pharma PQR Software Transforms Quality Assurance and Risk Management  In pharmaceutical manufacturing, maintaining high product quality and regulatory compliance is a constant challenge. Quality Assurance (QA) teams must ensure that every product meets strict regulatory standards while managing risks […]

by QEdge Team

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February 12, 2025
Regulatory Expectations for Pharma QMS
QMS  ·  Quality Management 
Regulatory Expectations for Pharma QMS: FDA, EMA, and ICH Guidelines

Regulatory Expectations for Pharma QMS: FDA, EMA, and ICH Guidelines  Ensuring quality, safety, and compliance is the foundation of pharmaceutical manufacturing. A well-implemented Pharmaceutical Quality Management System (QMS) is essential for meeting global regulatory expectations. Regulatory bodies like the U.S. […]

by QEdge Team

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February 11, 2025
The Importance of Risk-Based Software in Pharma
QMS  ·  Quality Management   ·  Risk based software validation
The Importance of Risk-Based Software in Pharma

Why Risk-Based Software is Crucial for Pharma Manufacturers In pharmaceutical manufacturing, managing quality and compliance is a complex task. With strict regulations and evolving standards, traditional approaches to quality management often fall short. This is where risk-based software in pharma […]

by QEdge Team

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December 18, 2024
QMS
The Critical Role of Vendor Qualification in Pharma Manufacturing

Why Vendor Qualification in Pharma is Essential  In your pharmaceutical manufacturing operations, vendor qualification is crucial for maintaining product quality, safety, and regulatory compliance. This process involves a detailed evaluation of suppliers to ensure that they meet the necessary quality […]

by QEdge Team

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November 5, 2024
Change Control
QMS
Gain Full Control Over Your Pharmaceutical Processes with Effective Change Control

Change Control in Pharmaceutical Manufacturing: Why It’s Critical  Yes, change control in pharmaceutical manufacturing refers to a formal process used to manage changes to processes, procedures, equipment, and systems in a controlled and systematic manner. The main goal of change […]

by QEdge Team

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October 3, 2024
Quality Management
QMS  ·  Quality Management 
Is Your Quality Management System Ready for the Digital Age?

In the fast-evolving pharmaceutical industry, managing quality efficiently and effectively is more crucial than ever. Traditional quality management systems often struggle to keep pace with the growing complexities of regulatory demands, data management, and operational efficiency. An electronic Quality Management […]

by QEdge Team

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October 3, 2024
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