November 2020
S
olutions promoting compli-
ance focus on application soft-
ware and IT/OT infrastruc-
ture. Application software should
support 21 CFR Part 11 through
an HMI with electronic signature
access; a tamper-proof audit trail
recording alarms, events, invalid
test runs and log-in attempts; and
integration of single sign on, access
permission, and role definitions
across the entire automation infra-
structure. Additionally, all applica-
tion software should have version
control for change management.
Modern IT and OT infrastruc-
ture should include a process histo-
rian with data retention capability
a nd prov ision for a n orchestra-
tion layer to generate electronic
reports. This ensures consistency
and avoids human error often due
to paper reporting. An automation
system shou ld suppor t business
continuity and prevent data loss
through backup and restore pro-
visions, end-point security, patch
tracking and management, and the
latest operating system.
Once a basic system is in place,
it w i l l b e i mp or t a nt to ma i n-
tain data integrity for the next 20
years. Visua lization technolog y
supporting streamlined operational
workf low will improve quality and
consistency throughout the life of
your facility. Providing operations
with a holistic view that allows for
proper work planning provides in-
sights into upcoming events and
makes it easier to take appropriate ac-
tions sooner to preserve the quality of
each batch. Combining visualization
with orchestration can provide com-
pliance to legacy equipment.
Advanced data analysis platforms
that consolidate business-wide data
provide real-time visibility and pre-
dictive insights. This minimizes
regulatory risk by providing a view
of compliance across the enterprise
and supporting paperless digital
transformation. It also allows com-
parison to a golden batch, and in-
sights allowing improvements in
quality and reduced waste.
Finally, safet y and securit y in
the life sciences industry is espe-
cially critical; in addition to pro-
tecting workers and facilities, it is
important to be confident in the
integrity and safety of your final
product. Wit h recent repor ts of
cybersecurity threats in life sciences
companies, how can you improve
OT cybersecurity in your facility
to protect your data, process, and
ultimately the patients that depend
on your product?
Whether you are looking to build
an OT cybersecurity program at
your facility or across multiple sites
in your enterprise, you need to fol-
low best practices to improve your
cybersecurity posture.
To learn more about embedding
data integrit y into your produc-
tion automation and control pro-
cesses, v isit our Webinar Series
page for on-demand webinars on
audit readiness, improving cyber-
security, batch visualization and
workf lows, orchestration, and op-
erational intelligence. ◆
Planning Audit-Ready
Production Automation
Amit Samel and Tiffany Barnes
In today's environment of increasing
regulatory concerns, it is becoming
more important to plan automation
of life sciences production around
compliance and audit readiness.
Embedding data integrity and quality
support into automation from the
start enables improved visibility and
compliance across your operations.
Amit Samel is a Technical Solutions
Consultant with Honeywell's Life Sciences
initiative. Amit has been working in the
Life Science domain for the last 20 years
and has led the design, commissioning
and qualification of various Life Sciences
Manufacturing facilities.
Tiffany Barnes is a Technical Solutions
Consultant on the Honeywell Life Sciences
team, and has over 10 years of experience
working on projects implementing controls,
procedural operations and HMI across
various industries.
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