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For most of the major sections of the life sciences industry, a proper Quality Management System (QMS) is required. This is true for medical devices, pharmaceuticals, biologics manufacturers, and more. The FDA and other regulatory bodies provide guidance on how to develop a QMS and what the contents of said QMS should be. For medical devices, the FDA outlines their QMS requirements in 21 CFR part 820[1] and provides extra help for the development of a QMS through various guidance documents they release.

Even with the FDA providing what is needed in a QMS and help documents for guidance it can still be quite challenging to develop one. EMMA International has some tips for creating a proper QMS from the start. It is not so strange in the life sciences industry for a company to implement a QMS that fails to meet expectations. The QMS might not meet all the required regulations for the markets they are attempting to sell in, or it might be overly complex, or too simplistic, or something else. Whatever the case may be, having an improper QMS in place can cause serious issues for a company.

When a company discovers that its QMS is not working properly there are a few paths they can decide to take. The first path is a complete gutting of the old QMS. Throw the whole thing out and start over. While this tactic may sound appealing it is important to note that it will present many issues for a company. For example, a company that is just starting up would have an easier time than a company that has been around for decades. To throw out the bad QMS completely would require holding onto all the needed records and data and then transferring them into the format of whatever new QMS is put into place.

Another option for dealing with a bad QMS is to revamp the current QMS. While the older QMS may not be optimal, there may be aspects of it that are still good for use. The document numbering system may be good or the templates used for recording keeping or maybe the procedures are just missing a few key points that can just be added in. Reviewing the entire QMS and figuring out which parts to keep and which parts either need to be thrown out or reworked is a daunting task but one that will ultimately prove beneficial. Users of the QMS will appreciate the familiar structure and the easier use that comes with a revamped QMS. EMMA International can help QMS remediation, whether that be developing an entirely new QMS or reworking an old one. EMMA International is capable of developing a QMS so that is compliant with whatever regulatory standards are needed by the market a company will be selling in. Give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (September 2018) Quality System (QS) Regulation/ Medical Device Good Manufacturing Practices, Retrieved 12/05/2021 from https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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