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
Cov
ToC
Free Info at http://info.hotims.com/79420-760
21
There is no room for error
when working with human health
Emerson's fluid control & pneumatics portfolio
addresses the unique needs of analytical instrument
& medical device manufacturers. Our team of experts
work with you to provide a complete customized
solution, based on your time to market requirements.
Learn more at: Emerson.com/medical
The Emerson logo is a trademark and a service mark of Emerson Electric Co. © 2021 Emerson Electric Co.
http://info.hotims.com/79420-760 http://info.hotims.com/79420-341

Medical Design Briefs - December 2021

Table of Contents for the Digital Edition of Medical Design Briefs - December 2021

Medical Design Briefs - December 2021 - Intro
Medical Design Briefs - December 2021 - Cov4
Medical Design Briefs - December 2021 - Cov1a
Medical Design Briefs - December 2021 - Cov1b
Medical Design Briefs - December 2021 - Cov1
Medical Design Briefs - December 2021 - Cov2
Medical Design Briefs - December 2021 - 1
Medical Design Briefs - December 2021 - 2
Medical Design Briefs - December 2021 - 3
Medical Design Briefs - December 2021 - 4
Medical Design Briefs - December 2021 - 5
Medical Design Briefs - December 2021 - 6
Medical Design Briefs - December 2021 - 7
Medical Design Briefs - December 2021 - 8
Medical Design Briefs - December 2021 - 9
Medical Design Briefs - December 2021 - 10
Medical Design Briefs - December 2021 - 11
Medical Design Briefs - December 2021 - 12
Medical Design Briefs - December 2021 - 13
Medical Design Briefs - December 2021 - 14
Medical Design Briefs - December 2021 - 15
Medical Design Briefs - December 2021 - 16
Medical Design Briefs - December 2021 - 17
Medical Design Briefs - December 2021 - 18
Medical Design Briefs - December 2021 - 19
Medical Design Briefs - December 2021 - 20
Medical Design Briefs - December 2021 - 21
Medical Design Briefs - December 2021 - 22
Medical Design Briefs - December 2021 - 23
Medical Design Briefs - December 2021 - 24
Medical Design Briefs - December 2021 - 25
Medical Design Briefs - December 2021 - 26
Medical Design Briefs - December 2021 - 27
Medical Design Briefs - December 2021 - 28
Medical Design Briefs - December 2021 - 29
Medical Design Briefs - December 2021 - 30
Medical Design Briefs - December 2021 - 31
Medical Design Briefs - December 2021 - 32
Medical Design Briefs - December 2021 - 33
Medical Design Briefs - December 2021 - 34
Medical Design Briefs - December 2021 - 35
Medical Design Briefs - December 2021 - 36
Medical Design Briefs - December 2021 - 37
Medical Design Briefs - December 2021 - 38
Medical Design Briefs - December 2021 - 39
Medical Design Briefs - December 2021 - 40
Medical Design Briefs - December 2021 - 41
Medical Design Briefs - December 2021 - 42
Medical Design Briefs - December 2021 - 43
Medical Design Briefs - December 2021 - 44
Medical Design Briefs - December 2021 - 45
Medical Design Briefs - December 2021 - 46
Medical Design Briefs - December 2021 - 47
Medical Design Briefs - December 2021 - 48
Medical Design Briefs - December 2021 - 49
Medical Design Briefs - December 2021 - 50
Medical Design Briefs - December 2021 - 51
Medical Design Briefs - December 2021 - 52
Medical Design Briefs - December 2021 - 53
Medical Design Briefs - December 2021 - 54
Medical Design Briefs - December 2021 - 55
Medical Design Briefs - December 2021 - 56
Medical Design Briefs - December 2021 - 57
Medical Design Briefs - December 2021 - 58
Medical Design Briefs - December 2021 - 59
Medical Design Briefs - December 2021 - 60
Medical Design Briefs - December 2021 - 61
Medical Design Briefs - December 2021 - 62
Medical Design Briefs - December 2021 - 63
Medical Design Briefs - December 2021 - 64
Medical Design Briefs - December 2021 - 65
Medical Design Briefs - December 2021 - 66
Medical Design Briefs - December 2021 - 67
Medical Design Briefs - December 2021 - 68
Medical Design Briefs - December 2021 - 69
Medical Design Briefs - December 2021 - 70
Medical Design Briefs - December 2021 - 71
Medical Design Briefs - December 2021 - 72
Medical Design Briefs - December 2021 - 73
Medical Design Briefs - December 2021 - 74
Medical Design Briefs - December 2021 - 75
Medical Design Briefs - December 2021 - 76
Medical Design Briefs - December 2021 - 77
Medical Design Briefs - December 2021 - 78
Medical Design Briefs - December 2021 - 79
Medical Design Briefs - December 2021 - 80
Medical Design Briefs - December 2021 - 81
Medical Design Briefs - December 2021 - 82
Medical Design Briefs - December 2021 - 83
Medical Design Briefs - December 2021 - 84
Medical Design Briefs - December 2021 - 85
Medical Design Briefs - December 2021 - 86
Medical Design Briefs - December 2021 - 87
Medical Design Briefs - December 2021 - 88
Medical Design Briefs - December 2021 - 89
Medical Design Briefs - December 2021 - 90
Medical Design Briefs - December 2021 - 91
Medical Design Briefs - December 2021 - 92
Medical Design Briefs - December 2021 - 93
Medical Design Briefs - December 2021 - 94
Medical Design Briefs - December 2021 - Cov3
Medical Design Briefs - December 2021 - Cov4
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https://www.nxtbook.com/smg/techbriefs/22MDB07
https://www.nxtbook.com/smg/techbriefs/22MDB06
https://www.nxtbook.com/smg/techbriefs/22MDB04
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https://www.nxtbook.com/smg/techbriefs/22MDB03
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https://www.nxtbook.com/smg/techbriefs/21MDB09
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