Page 141 - DCAP603_DATAWARE_HOUSING_AND_DATAMINING

Unit 6: Source Integration

the idea notes
With a very rich history our client built its place on the market on a company culture
oriented toward customer satisfaction and the quality and reliability of their solutions. Our
customer’s extensive client portfolio of large companies has driven the need for numerous
interfaces for most laboratory information systems and instruments available on the
market. The Middleware/Data Management software enables clinical labs to consolidate
test information from various instrument systems and manage data in real-time.
the challenge
For manufacturers and clinical laboratories, software is the premier cause of postponements
of instrument launches. The software that causes most delays is the one that mediates
interactions between laboratory instruments and the laboratory information system (LIS)
middleware.
In order to speed up instruments go-to-market times, the middleware solutions needed
to feature in a highly customizable work flow, an entire range of functionalities like:
multi-disciplines, multi-sites, multi-LIS, multi-instruments, multi-users, multi-languages,
automatic results validation, delta checking, reflex testing, quality control, results editing,
and archiving and restoring.
The solution also needed to comply with the strict regulatory framework in the area of
clinical related operations like 21 CFR Part 11, FDA approval or CE marking. On top of
this, our client’s own standards and certifications implied total quality control over the
development process to fully contribute to products destined to become homologated for
the U.S. and European markets.
the solution
OSF Global Services partnered with the client building a mixed team with his own staff,
working from the client’s own specifications to build tools and framework elements.
The use of open standards and service-oriented architectures (SOA) to build the middleware
was selected to embed the digital library information sources in the technical frameworks,
thus obtaining an open, reusable middleware that can bridge the complex functionality of
the LIS with the instruments interfaces.
Running off a desktop station, the middleware system views, tracks, and manages from
one location all laboratory instruments, to enable automatic validation and reporting of
normal results, according to rules programmed into the software. With reporting modules
such as regulatory provider, audit and auto-validation, quality control interface, and up to
50 instruments driver development, the middleware system developed provides a versatile
response to a variety of issues.
Heavy quality control documentation, testing and process maturity procedures were
implemented all throughout the development of the project to ensure compliance with all
quality standards to integrate with client’s own processes and procedures as well as the
challenging clinical environment requirements.
technologies

Microsoft .Net Framework 2.0,
C Sharp,
Dev Express,
Engine reporting, code covering tools

Contd...

LoveLy professionaL university 135