Innovations at INTERPHEX Guide 2022 - 15

Example: Customizable Enterprise Software to
Connect Data to Critical Decision Making
Data integrity and connectivity are key requirements for the
pharmaceutical industry, and the desire to easily manage
electronic data and metadata from a central location is
often a specification for new software in pharmaceutical
manufacturing, such as software for TOC instruments across
multiple sites. Facilities must not only assure data integrity
for compliance and its role in patient safety, but they must
also strive to achieve the efficiency and productivity gains
necessary to keep up with production demands. This means
critical data from both the production and lab systems should
feed into a location where fast, informed decision making can
be made to ensure compliance and increase efficiency. In
order to support requirements, software must meet 21 CFR
Part 11 compliance and follow ALCOA+ principles.
Remote data management is another core component of
a digitally enabled lab. The ability to review and trend realtime
data - such as online TOC and conductivity monitoring
of water systems - simplifies processes and allows release
testing to happen much faster through secure, encrypted
data transfer. QC labs desire highly customizable enterprise
solutions that are compatible with Active Directory (AD) for
easy and secure login, review, and e-signing. In conjunction
with network-based data management, labs need data
security features such as customizable access, roles, and
permissions with the ability to review and import audit trails
regularly. With this type of software, data from multiple
instruments at different sites across the world is managed
from a single location, enabling management of real-time
data, OOS results, and audit trails as events happen - giving
rise to smarter QC.
Conclusion
As organizations drive toward 4.0, important shifts include
introducing new technologies and digital tools, as well
as accepting new ways of working. Technology is needed
not only to automate testing or increase the speed of data
to real-time, but also to integrate data and help eliminate
the silos that exist in most organizations. The evolution
to becoming automated, paperless, and fully digitized -
with an eventual shift from traditional batch processing to
continuous manufacturing - includes many steps along the
way that will challenge QC labs and related functional groups
to think differently and begin implementing new testing
approaches. While there is not a one-size-fits-all plan, QC labs
should feel encouraged by recent advances in automated
analytical testing technologies, a shift toward at-line and
online monitoring, and advances in compliant software and
data analytics to support the digital transformation needed
for Pharma 4.0.
About the Authors
Kaitlyn Vap is the Life Sciences Lead Product Application
Specialist responsible for supporting Sievers total organic
carbon (TOC) customers. She works with companies in the
pharmaceutical industry to implement Sievers analytical
instruments for the validation of laboratory water and drug
products in accordance with global pharmacopeia regulatory
standards. As an application specialist, she also explores new
and/or developing applications to streamline the process of
water and drug product testing. Kaitlyn holds a B.S. in Chemical
Engineering from the University of Wyoming.
Hayden Skalski is the Life Sciences Product Application
Specialist for the Sievers Instruments product line, specializing
in bacterial endotoxins testing (BET). Hayden has over 8 years
of experience in the pharmaceutical industry and Quality
Control Microbiology and has presented on numerous topics
surrounding endotoxin testing. Previously, Hayden held roles at
Charles River Laboratories, Regeneron and Novartis, validating
and executing method development protocols for endotoxin
testing, providing customer support, troubleshooting and
supporting high-volume product testing. Hayden has a B.S. from
the University at Albany (SUNY) in Biology.
Sievers Analytical Instruments
Visit our website www.sieversinstruments.com
for more information.
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