Medical Design Briefs - December 2021 - 21

procedures that lead to compliant
actions and activities. A supplier must
provide the appropriate software structure
and features that allow the user to
create those processes and procedures
that meet the requirements of the standards.
This may seem like a subtle distinction,
but a software package that can
create a hard copy test method and hard
copy results reports that can be printed,
signed, and stored according to company
operating procedures could be called
" 21 CFR Part 11 " compliant, though not
particularly " audit-friendly. " The real
intent of the regulation is to move to a
more efficient, effective, and secure
electronic process.
The technical requirements of FDA
21 CFR Part 11 provide guidelines for
integrity and traceability in three key
areas: security, audit trail, and signatures.
Many laboratories have transitioned,
or are transitioning in some
manner, to electronic records and signatures
as outlined in Part 11. Several features
are now typically included with systems
and software that help facilitate
compliance with the standard.
Inspectors from the FDA now audit
laboratories to ensure compliance. If
processes and procedures are found to
be out of compliance, a warning letter
could be issued. FDA data shows that
over 5,000 of these warning letters were
issued in 2018 alone. Poor audit results
can mean delays in product delivery,
time lost in preparation for audit followup,
fines (sometimes into the millions of
dollars), and time lost chasing paper
records errors. In this environment,
non-compliance is not an option.
In all cases, a strong working relationship
between biomedical manufacturers
and their mechanical testing suppliers is
critical to a successful quality control
program. By working closely with testing
experts, quality control labs can optimize
their equipment and software to
efficiently perform all the types of testing
necessary for their product while
ensuring consistency in their results and
achieving regulatory compliance. A welloptimized
lab is poised to meet growing
demands for throughput while mitigating
risk for both the manufacturer and
the product consumer.
This article was written by Frank Li, Global
Product Support Lead, and James Ritchey,
Global Services Innovation Director, Instron,
Norwood, MA. For more information, visit
http://info.hotims.com/79420-341.
Medical Design Briefs, December 2021
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Medical Design Briefs - December 2021

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