The 21 CFR Part 11 is a Food and Drug Administration (FDA) regulation specifying the requirements for electronic records and signatures. The purpose of 21 CFR Part 11 is to ensure the integrity, reliability, and authenticity of electronic records and signatures. This...
A Medical Device Quality Management System (QMS) is a set of policies, processes, and procedures that a manufacturer of medical devices has in place to ensure that their products are safe and effective for their intended use. The QMS includes all aspects of design and...
Pharmaceutical Quality Management System (QMS) is a set of procedures and practices contributing to product quality. The QMS must reflect the relevant regulatory requirements applicable to the industry and company. In the pharmaceutical industry, some of the important...
An effective quality management system (QMS) is a system that enables a company to consistently provide products and services that meet customer and regulatory requirements. Effective quality management has become a necessity in the Life Science industry. A...
For all industries, a Quality Management System (QMS) is essential to formalize the processes, procedures, and responsibilities to place safe and high-quality products on the market. In the Life Sciences industry, compliance with relevant requirements is highly...
