FDA 21 CFR Part 820 Quality System Regulation

Software Designed to Meet FDA 21 CFR Part 820 Quality System Regulations Eliminates Manufacturers’ Compliance Pains

FDA 21 CFR Part 820 quality system regulations exist to make plain the Current Good Manufacturing Practice (CGMP) guidelines that pertain to the quality processes employed during the design, manufacturing, packaging, labeling, storing, installing and servicing of finished medical products. A variety of specialized software systems on the market have been expressly designed to facilitate medical product manufacturers’ compliance with FDA 21 CFR Part 820 quality system regulations, improve product quality, and accelerate time to market. The information presented here has been provided to help manufacturers understand what they should be looking for when searching for a quality management software solution that can help them achieve their compliance goals.

Compliance with 21 CFR 820 and ISO 13485 Using MasterControl
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