FDA Compliance Without the Stress

by | Jul 17, 2019 | Clinical Trials, FDA, Medical Devices, Pharmaceuticals, Quality Systems, Regulatory, Software

Ensuring you have a robust Quality Management System (QMS) is the first step in maintaining compliance with both FDA and ISO regulations and requirements. A good software-based quality management system can make the process much easier. A paper-based or multi-software system can often lead to extraneous work and missing or weak records. Many FDA 483s are caused by lacking or inadequate procedures and then lacking or inadequate documentation and documentation maintenance.

EMMA International has partnered with Saphir Consult to bring QualiPro to the USA. QualiPro is a dynamic enterprise QMS capable of housing the entire QMS by hosting 12 modules including CAPA, Complaints, Documentation, and Nonconformances and each is customizable to meet specific needs. An advantage of housing the entire QMS on QualiPro is that all the modules interact, further streamlining the process and reducing waste. For example, a CAPA can be created from the audit, meeting, and nonconformance modules – to name a few. It then can track each task to its specific module and notify the responsible person(s) until the task has been completed.

QualiPro is fully customizable to fit each company’s needs and can grant the freedom to go to a fully paperless quality system. Going paperless alone can save money and reduce headaches, but that coupled with the rest of the capabilities will capitalize on the advantages as well.

There are many more advantages to moving to the QualiPro system, which will be highlighted further in this blog series. If you are interested in learning more, please visit https://qualiprousa.com/ and contact us at 248-987-4497 or info@emmainternational.com.

Jayme Brace

Jayme Brace

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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