FDA Guidelines


FDA guidelines are established to suggest and/or enforce compliance with U.S. food and drug regulations.

FDA guidelines, especially guidance documents and clues from investigators, allow companies to see how the FDA interprets 21 CFR regulations. These regulations often ensure the quality and safety of products manufactured and sold in the U.S. marketplace.

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Staying Abreast of FDA Guidelines

It's easy to stay abreast of FDA guidelines when you have a quality management team. However, even with a quality management team the interpretations of those guidelines will differ depending on the company's needs and the senior management personnel's differing opinions on how a quality management and quality assurance should be managed.

Once a quality management plan has been determined and documented it is generally a nightmare trying to manage it manually. Companies that automate their quality management systems gain not only in quality, but increased conformance with FDA guidelines as well.

How MasterControl Helps With FDA Guideline Compliance

MasterControl provides solutions that streamline and automate quality management practices so that your company can stay compliant with FDA guidelines. MasterControl professionals stay abreast of FDA guidelines and often develop many of their software features to meet those guidelines.

Learn More on FDA Guidelines

If you are interested in learning more about FDA guidelines, MasterControl's document management, process management, CAPA management, PLM management, BOM management or customer complaints management software solutions, please feel free to contact a MasterControl representative and learn how to become an automated FDA approved company.