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 […]
QMS
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. […]
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 With increasing regulatory requirements, rising quality standards, and the push for automation, relying on outdated, paper-based quality management systems is no longer viable.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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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