Apartis developed instrument control and result analysis software for a Stanford startup company that has created a portable instrument and assay system capable of delivering sensitive biomarker test results in under 20 minutes. The Apartis software controls the instrument, guides users through workflows, manages data and quality control, and meets FDA requirements for medical device approval. Apartis helped define requirements, provided documentation and verification plans, and proposed support options to keep maintenance costs low over the lifetime of the application.

1. APARTIS INFORMATION MANAGEMENT Sheet #1412
Instrument
Interface &
Results Analysis
Software
510(k)
Compliant
Development
SENSITIVE MAGNETO-NANO SENSOR TECHNOLOGY RESULTS AVAILABLE IN 20 MINUTES
Apartis is working with a Stanford
University startup who has developed novel
assay and instrumentation technology for
the diagnostic market. Our client offers a
portable instrument and assay system
capable of delivering an extremely sensitive
test result for target biomarkers in less than
20 minutes. Assay and instrument
technology utilize novel magneto-nano
sensor methodologies developed at
Stanford.
Our client engaged Apartis’ services to
develop their new instrument control and
result analysis software. The Apartis
software controls the instrument and
provides a guided workflow to the user. Kit
Lot management with inventory control is
the base for calibration workflows, external
control workflows and sample workflows
with internal controls. All data calculations
and verification of acceptance criteria, as
well as quality control is implemented by
Apartis. Documentation supplied and
software testing performed by Apartis meet
FDA requirements for the system’s (Class II
medical device) PMA/510(k) submission.
The application supports multiple
languages with easy-to-translate
architectures. The software is a standalone
solution that is easy to install. The
architecture uses a license free local Oracle
11gR2 database which provides a robust,
safe and protected data storage
environment. Communications to LIS and
LIMS systems are implemented in multiple
ways, with the option to easily add more
interfaces, like the standard Apartis ASTM
and HL7 communication tools.
Apartis helped our customer define
software requirements and layout the
software lifecycle and provided a FDA
compliant documentation plan and V&V
strategy. Furthermore, Apartis proposed
add-ons for field installation and support
that will keep the maintenance cost low
during the lifetime of the application.
Finally, the multi-tier architecture of the
application is well structured and logically
modularized. New assays can be added by
simply adjusting several configurable
parameters. This reduces the resources
and time required for verification of the
new assay(s) because verification is only
needed at the highest level, not
throughout the complete software.
Measurement View
A measurement curve with 4 targets is displayed in the
above screen shot. Measurement is plotted in real-time.
Calibration View
A five point calibration curve is displayed in the above
screen shot. The software intuitively guides users
through calibration workflows.
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New Technology to Market
by Lani Havlicek

2. APARTIS INFORMATION MANAGEMENT | Sheet #1412 2
Custom Software Development Services
Software Solutions
Apartis offers total lifecycle custom
software development services for
healthcare and life sciences. Customer
success is the foundation of our success.
Our complete lifecycle services include
technical consultation, requirements
development, risk management,
engineering, testing, documentation,
compliance support and maintenance.
Apartis develops the software tools you
need for success. With nearly two decades
of software design for medical devices and
instrumentation, we fully support
compliant design, development and
documentation.
• FDA/IVD/CE/ISO Compliance
• User Interfaces
• Instrument & System Control
• Data Management & Mining
Sector Expertise
We help a wide variety of businesses, from
individual laboratories to multinational
enterprises, design flexible and scalable
software tools. User interfaces support
corporate identities and multiple languages
(including Japanese and other Asian
languages).
• Component Integration
• Touchscreen Interfaces
• LIMS/LIS Systems & Interfaces
• Laboratory Automation
• Diagnostic & Research
Applications
Quality
Apartis’ quality system is based on the
FDA’s general principles of software
validation. We support the following
design & development guidelines:
• 21 CFR Part 20 (quality
system regulations)
• 21 CFR Part 11 (electronic
records & signatures)
• ISO 62304 (software lifecycle
process for medical device
software)
• ISO 13485 (quality
management system for
medical devices
Rely on our expertise to reduce your
software development time and overall
product lifecycle costs. Our experience will
get you the right software solution. On
time and on budget.
apartis
Information
Management
4900 Hopyard Rd, Ste 100
Pleasanton, CA 94588
www.apartis.com
Phone: 925.468.4128
Email: aiminfo@apartis.com