In the highly regulated pharmaceutical and life sciences sector, adherence to FDA guidelines is critical for ensuring product safety, efficacy, and compliance. Here’s a comprehensive look at the top 10 common FDA-related compliance oversights, along with how eQMS software solutions […]
EQMS
Introduction Talking clearly and working together is super important in the world of medicine-making. As pharma companies use more and more electronic Quality Management Systems (eQMS), some folks wonder if this hurts how everyone talks to each other. This […]
ICH Q9 is crucial for maintaining a strong Quality Management System (QMS) for pharmaceutical companies. It changes how risks are handled and QMS processes are managed using digital tools. The ICH Q9 guideline, also known as Quality Risk Management, […]
In the field of Quality Management Systems (QMS), there are two types of audits commonly conducted: 1) internal audits and 2.) Party audits, which are typically carried out by a certifying authority. However, there is one obvious missing in both […]
Quality management software (QMS) is a type of software that helps businesses manage and improve the quality of their goods, services, and processes. It provides tools for developing quality management systems, automating quality-related operations, tracking quality indicators, and assuring compliance […]
Quality Assurance (QA) and Quality Control (QC) are two distinct processes that are part of quality management and are often used in the context of product and service development. While they share the common goal of ensuring the quality of […]
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