No matter what scope your product falls under (medical device, drug, biologic, IVD) the regulatory requirements for your Quality Management System are strict. The FDA established its various Codes of Federal Regulations to enforce that a QMS is not just a “nice-to-have” for the life-science industry, it is the law. To me, however, a QMS should do more than just check a box for the FDA. Your QMS should be optimized towards your actual operations, to ensure it fulfills its purpose of supporting the several GxP standards, and ultimately facilitates your organization in creating safe and effective products...

1. Developing a QMS in an FDA-Regulated Industry
By: Madison Wheeler
No matter what scope your product falls under (medical device, drug, biologic, IVD) the
regulatory requirements for your Quality Management System are strict. The FDA established its
various Codes of Federal Regulations to enforce that a QMS is not just a “nice-to-have” for the
life-science industry, it is the law. To me, however, a QMS should do more than just check a box
for the FDA. Your QMS should be optimized towards your actual operations, to ensure it fulfills
its purpose of supporting the several GxP standards, and ultimately facilitates your organization
in creating safe and effective products.
A simple Google search would show you an abundance of options for off-the-shelf QMS’s.
These are usually advertised as a full suite of ready to implement procedures that are compliant
with an array of regulatory requirements and international standards. While these procedures
may check the box of compliance, assuming they actually are compliant with the regulations, I
haveseennumerousinstancesofthese off-the-shelfQMS’scausing moreheadachesforfirms. The
main reason is that the FDA tells you what to implement, but not how to implement it. So, for
example, when you purchase a CAPA procedure you are stuck with whatever the author of that
procedure thinks you should do in a CAPA process, without considering your firm’s actual
scenario.IfthatCAPAprocedure is too strict you couldruninto “death by CAPA”,if theprocedure
is notstrict enoughyou couldbe letting serious quality issues gounnoticed. To use the Goldilocks
Principle, your QMS must be “just right”, otherwise you will run into serious compliance issues.
So, how do you develop an optimized QMS? It starts by having a thorough understanding
of your product and which regulatory requirements and international standards applicable to it.
Once you have that you need to start developing your procedures, the framework of your QMS.
Developing a QMSinfrastructuretakesa balanceofboth understanding thepreviously mentioned
requirements, and how your organization applies them. A review of the citation sources for 483’s
that the FDA issued in FY 2020 shows you that most are due to “lack of or inadequate
procedures”.1 While developing documentation seems fairly straightforward, there are a lot of
ways you can fall into the trap of “inadequate” procedures.
Developing a QMS in an FDA-regulated industry is not always for the faint of heart. It
takes not only a complete understanding of the regulatory requirements and international
standards but also an alignment with your organization’s processes. EMMA International has
helped countless clients by supporting theirQMSdevelopmentwith ourproprietary methodology,
CLIC®. Our team of experts has experience both developing QMS’s from the ground-up and
assisting firms in QMS remediation efforts. If you need help developing, implementing,
optimizing, or maintaining your QMS, EMMA International is available 24/7. Call us at 248-987-
4497 or email info@emmainternational.com to get connected with our team of experts today!
1 FDA(Nov 2020) Inspection Observations retrieved on02/02/21 from: https://www.fda.gov/inspections-compliance-enforcement-and-
criminal-investigations/inspection-references/inspection-observations