
Investigation of OOS Results in Analytical Testing
When a laboratory test in the pharmaceutical industry gives a result outside its approved limits, it is classified as an Out-of-Specification (OOS) result. Such an

When a laboratory test in the pharmaceutical industry gives a result outside its approved limits, it is classified as an Out-of-Specification (OOS) result. Such an

Strong quality management supports every stage of making medicine. You need safe, useful, and consistent products from start to finish. Companies use a Quality Management

The pharmaceutical industry is evolving at warp speed, but many Quality Management Systems (QMS) are stuck in the past. Paper-based processes, once seen as the

In the high-stakes world of pharmaceuticals, quality is not just a checkbox on a regulatory form; it’s the heartbeat of every operation. Every pill, every

The medical device industry requires product safety assurance, adherence to regulations, and customer expectations. A properly implemented QMS can lay the foundation for the attainment of

Artificial Intelligence has certainly become part of our day-to-day lives. It is latched to our day-to-day life processes and has made technology easy to use

Quality Key Performance Indicators (KPIs) are essential, quantifiable metrics that pharmaceutical companies use to evaluate the effectiveness of their processes, services, and products. In the

The pharmaceutical industry, particularly in Europe, faces an increasingly complex landscape. With regulatory pressures, evolving market demands, and the ever-present need for efficiency and quality,

In the pursuit of operational excellence and quality assurance, deviations from established norms are not just expected but anticipated. However, what truly differentiates successful organizations

Change control is a critical process in regulated industries, such as pharmaceuticals, medical devices, and food and beverages. It involves managing changes to products, processes,
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Annual Product Quality Review

Electronic
Logbook System

Laboratory Information Management System

Manufacturing Execution System

Calibration & Preventive Maintenance

Regulatory Information Management System

Learning Management System

Environmental Monitoring System

Electronic Quality Management System

User Access Management System

Document Management System

Quality Control
System

Cleaning Validation
Software

Process Validation
Software

Regulatory Surveillance Management System