Managing Risk with EQMS

by | May 18, 2018 | Uncategorized

Having the ability to meet the customers’ requirements, comply with international standards and regulations, and mitigate potential risks is what’s on the mind of any QA or RA professional in the life sciences industry. With that said, being able to utilize an Enterprise Quality Management Software (EQMS) ensures that tasks and activities are being accomplished in an efficient and timely manner.

Although there are many EMQS platforms on the market place today, there is only one Intelligent EQMS, and that is QualiPro. During this brief webinar, we will provide you with an overview of QualiPro, its structure and capabilities. Also, we will briefly demonstrate how QualiPro is the ONLY EQMS that can truly help with your risk management and compliance challenges.

Emma International

Emma International

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
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.

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