The U.S. Food and Drug Administration (FDA) established GMP regulations. GMPs apply to every aspect of drug development and manufacturing. They are in place to ensure product quality and consumer safety. You can’t accomplish this by using manual processes. Not anymore. To do the best job, you need the best tools. Build quality into manufacturing processes by automating the entire product life cycle. Adopt a digital QMS. Achieve a high level of quality and simplify compliance.
There are numerous GMP quality-related regulations enforced by the FDA. Two of the more important are 21 CFR Parts 210-211 and 21 CFR Part 820. The first set relates to GMP for drug products. Part 820 outlines GMP for developing medical devices. 21 CFR guidelines are in place to ensure drug products meet requirements for safety, quality, strength, and purity.
ISO 13485 and ISO 14971 quality standards cover the production of medical devices. ISO 13485 provides a model for creating and maintaining an effective QMS. ISO 14971 offers guidelines for risk management. They are specific to medical devices. Together, these standards help manufacturers put processes in place that comply with regulations related to GMP quality.
Our QMS is exactly what you need to simplify compliance and ensure GMP quality.Get Started Now