Medical Design Briefs - December 2022 - 16

Ensuring Regulatory Compliance
by Digitizing Change Control
in Life Sciences Product Development
M
16
edical device manufacturers
face constant changes
coming from both internal
and external sources.
Change is inherent to any
production environment, as well as any
quality-driven process because they are dynamic
by nature. The key to safe and effective
production is change control. The
key to continuous improvement is leveraging
it - all while managing the risks inherent
with disruption and maintaining
the safety and efficacy of the product.
Internal feedback from audits, executives,
employees, and customers can all
drive necessary change. External pressures
can stem from changes in standards
and regulations set by regulatory bodies,
such as the European Union Medical Device
Regulation (EUMDR), in addition to
shifting market demands and limitations.
Changes are further influenced by developing
technology. All of this makes for a
dynamic mix of change drivers, one that
may seem unmanageable and leave manufacturers
scrambling. However, with an
efficient change control system, OEMs
can manage change effectively by focusing
on areas that have the greatest impact
on the organization.
Common Challenges with Change
Control
Change control is integral to, if not
synonymous with, quality management.
It affects all the processes, products, and
largely the records that comprise life sciences
as a regulated industry. Changes
may involve modifications to equipment,
materials, facilities, designs, packaging
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and labeling, computer systems, and
training procedures. There is no reason
that change control should cause significant
delays in production, but it does.
When trying to implement postmarket
changes or execute a corrective action/
preventive action (CAPA), delays and difficulties
can be compounded further.1
Because of the direct link between
quality and control, regulations are in
place to ensure that changes don't put
the consumer at risk. It's critical that
manufacturers of regulated products adhere
to strict change control guidelines
and accurately document changes. Because
of this, there are several pain
points surrounding change control.
These include planning changes to
align with evolving regulations, reviewing
changes prior to implementation,
Medical Design Briefs, December 2022
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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
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