Medical Design Briefs - December 2022 - 18

MDB Statek Ad 0621.qxp_1/3 Page Vertical 5/26/21 12:21 PM
Digitizing Change
having qualified personnel approve
changes, and showing justifications for
and evidence of changes.
Ultra-Miniature - High Reliability
Quartz Crystals, Oscillators
and Sensors
UNSURPASSED QUALITY
THE MEDICAL INDUSTRY
COUNTS ON
UNSURPASSED QUALITY
THE MEDICAL INDUSTRY
COUNTS ON
Inspections commonly show a high
number of deficiencies in design control,
written procedures for production, and
written procedures for processes. They
also reveal deficiencies in the following
areas: inadequate planning, review by key
stakeholders, follow-up efforts, corrective
actions, incomplete documentation, insufficient
evidence and explanations, and
lack of training and communication.2 The
common complaint here goes back to insufficient
records. Everything must be documented
properly, further referenced, and
followed strictly. When there is an inspection,
producing the required documentation
can be very difficult in paper-based or
hybrid production environments.
Streamlining Change Control
With paper-based processes and production
records, change control guidelines
can easily go unmet without enforceable
workflows and automatic alerts to
indicate an oversight. In no time, wellmeaning
innovators can unknowingly
create an out-of-control production environment.
Digital controls, on the other
With a digital, integrated quality management
system (QMS), OEMs can easily
collect and analyze data, using it to review
how CAPA and other areas of the
quality management system, such as
training or design documents, work together.
Looking at trends revealed
through data allows for timely and proactive
decisions. Good data leads to good
decisions that improve the safety, efficacy,
and time to market of products. The
bottom line is that integrated processes
and advanced analytics lead to enhanced
efficiency - and these features are readily
available in a purpose-built digital
quality solution.
Change Control: Documentation
At the very core of change control is
documentation. Change control essentially
becomes a documentation management
issue. Documentation is used to establish
and update compliant procedures,
develop compliant products, and ultimately
show compliance to regulators.
According to the U.S. Food and Drug Administration
(FDA), an OEMs call to action
is to " write useful and effective documents
that
provide
direction
and
evidence
of compliance and quality. " 3
Change control is integral
to, if not synonymous
with, quality management.
Medical Grade Crystals,
Oscillators and Sensors
* High stability and precision
* Used in implantable devices
* Excellent long term aging
* Low power consumption
STATEK CORPORATION
ISO 9001
AS9100
512 N. Main St., Orange, CA 92868
Tel. 714-639-7810
Fax 714-997-1256
www.STATEK.com
18
hand, allow manufacturers and quality
personnel to efficiently initiate, review,
plan, and monitor changes with adequate
documentation, and these controls also
signal and secure communications.
OEMs can quickly see what is happening,
what has been done, and what needs to
be done. The result is a system that is in a
constant state of audit-readiness. With
more advanced digital systems, OEMs can
also ensure that employees are current
with training on the latest changes.
Change Control: Data
One of the biggest disadvantages of
paper- based processes is the challenge of
recruiting and analyzing large amounts
of data for continuous improvement.
www.medicaldesignbriefs.com
Using electronic records in the place of
paper documents allows the company to
easily adapt to changes and answer the
FDA's call to action in the following ways:
* Follow the company's own procedures
for document and record keeping.
* Enforce document controls, including
review, approval, and versioning.
* Leverage document templates to complete
larger records.
* Access documents remotely and utilize
electronic signatures.
Getting to the heart of the matter,
good documentation, in the form of
electronic records, makes it easier for
the company to share information, collect
data, and analyze it for best practice
when implementing changes.
Medical Design Briefs, December 2022
http://info.hotims.com/82328-775 http://www.medicaldesignbriefs.com

Medical Design Briefs - December 2022

Table of Contents for the Digital Edition of Medical Design Briefs - December 2022

Medical Design Briefs - December 2022 - COV1A
Medical Design Briefs - December 2022 - COV1B
Medical Design Briefs - December 2022 - Cov1
Medical Design Briefs - December 2022 - Cov2
Medical Design Briefs - December 2022 - 1
Medical Design Briefs - December 2022 - 2
Medical Design Briefs - December 2022 - 3
Medical Design Briefs - December 2022 - 4
Medical Design Briefs - December 2022 - 5
Medical Design Briefs - December 2022 - 6
Medical Design Briefs - December 2022 - 7
Medical Design Briefs - December 2022 - 8
Medical Design Briefs - December 2022 - 9
Medical Design Briefs - December 2022 - 10
Medical Design Briefs - December 2022 - 11
Medical Design Briefs - December 2022 - 12
Medical Design Briefs - December 2022 - 13
Medical Design Briefs - December 2022 - 14
Medical Design Briefs - December 2022 - 15
Medical Design Briefs - December 2022 - 16
Medical Design Briefs - December 2022 - 17
Medical Design Briefs - December 2022 - 18
Medical Design Briefs - December 2022 - 19
Medical Design Briefs - December 2022 - 20
Medical Design Briefs - December 2022 - 21
Medical Design Briefs - December 2022 - 22
Medical Design Briefs - December 2022 - 23
Medical Design Briefs - December 2022 - 24
Medical Design Briefs - December 2022 - 25
Medical Design Briefs - December 2022 - 26
Medical Design Briefs - December 2022 - 27
Medical Design Briefs - December 2022 - 28
Medical Design Briefs - December 2022 - 29
Medical Design Briefs - December 2022 - 30
Medical Design Briefs - December 2022 - 31
Medical Design Briefs - December 2022 - 32
Medical Design Briefs - December 2022 - 33
Medical Design Briefs - December 2022 - 34
Medical Design Briefs - December 2022 - 35
Medical Design Briefs - December 2022 - 36
Medical Design Briefs - December 2022 - 37
Medical Design Briefs - December 2022 - 38
Medical Design Briefs - December 2022 - 39
Medical Design Briefs - December 2022 - 40
Medical Design Briefs - December 2022 - 41
Medical Design Briefs - December 2022 - 42
Medical Design Briefs - December 2022 - 43
Medical Design Briefs - December 2022 - 44
Medical Design Briefs - December 2022 - 45
Medical Design Briefs - December 2022 - 46
Medical Design Briefs - December 2022 - 47
Medical Design Briefs - December 2022 - 48
Medical Design Briefs - December 2022 - 49
Medical Design Briefs - December 2022 - 50
Medical Design Briefs - December 2022 - 51
Medical Design Briefs - December 2022 - 52
Medical Design Briefs - December 2022 - 53
Medical Design Briefs - December 2022 - 54
Medical Design Briefs - December 2022 - 55
Medical Design Briefs - December 2022 - 56
Medical Design Briefs - December 2022 - 57
Medical Design Briefs - December 2022 - 58
Medical Design Briefs - December 2022 - 59
Medical Design Briefs - December 2022 - 60
Medical Design Briefs - December 2022 - 61
Medical Design Briefs - December 2022 - 62
Medical Design Briefs - December 2022 - 63
Medical Design Briefs - December 2022 - 64
Medical Design Briefs - December 2022 - 65
Medical Design Briefs - December 2022 - 66
Medical Design Briefs - December 2022 - 67
Medical Design Briefs - December 2022 - 68
Medical Design Briefs - December 2022 - 69
Medical Design Briefs - December 2022 - 70
Medical Design Briefs - December 2022 - 71
Medical Design Briefs - December 2022 - 72
Medical Design Briefs - December 2022 - 73
Medical Design Briefs - December 2022 - 74
Medical Design Briefs - December 2022 - 75
Medical Design Briefs - December 2022 - 76
Medical Design Briefs - December 2022 - 77
Medical Design Briefs - December 2022 - 78
Medical Design Briefs - December 2022 - 79
Medical Design Briefs - December 2022 - 80
Medical Design Briefs - December 2022 - 81
Medical Design Briefs - December 2022 - 82
Medical Design Briefs - December 2022 - 83
Medical Design Briefs - December 2022 - 84
Medical Design Briefs - December 2022 - 85
Medical Design Briefs - December 2022 - 86
Medical Design Briefs - December 2022 - 87
Medical Design Briefs - December 2022 - 88
Medical Design Briefs - December 2022 - 89
Medical Design Briefs - December 2022 - 90
Medical Design Briefs - December 2022 - Cov3
Medical Design Briefs - December 2022 - Cov4
https://www.nxtbook.com/smg/techbriefs/24MDB07
https://www.nxtbook.com/smg/techbriefs/24MDB06
https://www.nxtbook.com/smg/techbriefs/24MDB05
https://www.nxtbook.com/smg/techbriefs/24MDB04
https://www.nxtbook.com/smg/techbriefs/24MDB03
https://www.nxtbook.com/smg/techbriefs/24MDB02
https://www.nxtbook.com/smg/techbriefs/24MDB01
https://www.nxtbook.com/smg/techbriefs/23MDB12
https://www.nxtbook.com/smg/techbriefs/23MDB11
https://www.nxtbook.com/smg/techbriefs/23MDB10
https://www.nxtbook.com/smg/techbriefs/23MDB09
https://www.nxtbook.com/smg/techbriefs/23MDB08
https://www.nxtbook.com/smg/techbriefs/23MDB07
https://www.nxtbook.com/smg/techbriefs/23MDB06
https://www.nxtbook.com/smg/techbriefs/23MDB05
https://www.nxtbook.com/smg/techbriefs/23MDB04
https://www.nxtbook.com/smg/techbriefs/23MDB03
https://www.nxtbook.com/smg/techbriefs/23MDB02
https://www.nxtbook.com/smg/techbriefs/23MDB01
https://www.nxtbook.com/smg/techbriefs/techleaders22
https://www.nxtbook.com/smg/techbriefs/22MDB12
https://www.nxtbook.com/smg/techbriefs/22MDB11
https://www.nxtbook.com/smg/techbriefs/22MDB10
https://www.nxtbook.com/smg/techbriefs/22MDB09
https://www.nxtbook.com/smg/techbriefs/22MDB08
https://www.nxtbook.com/smg/techbriefs/22MDB07
https://www.nxtbook.com/smg/techbriefs/22MDB06
https://www.nxtbook.com/smg/techbriefs/22MDB04
https://www.nxtbook.com/smg/techbriefs/techleaders21
https://www.nxtbook.com/smg/techbriefs/22MDB03
https://www.nxtbook.com/smg/techbriefs/22MDB02
https://www.nxtbook.com/smg/techbriefs/22MDB01
https://www.nxtbook.com/smg/techbriefs/21MDB12
https://www.nxtbook.com/smg/techbriefs/21MDB11
https://www.nxtbook.com/smg/techbriefs/21MDB10
https://www.nxtbook.com/smg/techbriefs/21MDB09
https://www.nxtbook.com/smg/techbriefs/21MDB08
https://www.nxtbook.com/smg/techbriefs/21MDB07
https://www.nxtbook.com/smg/techbriefs/21MDB06
https://www.nxtbook.com/smg/techbriefs/21MDB05
https://www.nxtbook.com/smg/techbriefs/21MDB04
https://www.nxtbook.com/smg/techbriefs/21MDB02
https://www.nxtbookmedia.com