GxP compliance forms the backbone of regulated industries such as pharmaceuticals, biotechnology, and medical devices. Rooted in the principles of “Good Practice,” GxP encompasses various regulations and guidelines that ensure product safety, quality, and efficacy. These standards are not just legal requirements but fundamental to building trust with consumers and maintaining the industry’s integrity. As […]| eLeaP®
To ensure a smooth workflow, every employee in the supply chain must have at least a foundational understanding of AI and IoT systems.| eLeaP®
A successful QMS gap analysis should lead to an organization-wide culture of continuous improvement.| eLeaP®
Good Distribution Practice (GDP) is a critical framework designed to ensure that products, particularly pharmaceuticals and medical devices.| eLeaP®
In a clinical trial, the eCRF is the primary tool for documenting patient information, treatment details, and study outcomes.| eLeaP®
Explore the effectiveness of change control in ensuring the integrity of pharmaceutical products and compliance with regulatory standards.| eLeaP®
Ethical considerations are critical to medical device clinical studies. Manufacturers must ensure that their studies are conducted ethically.| eLeaP®
Here’s how cutting-edge technologies and methodologies reshape change control processes, enhancing industry efficiency and compliance.| eLeaP®
