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Mission Statement
Compliance Software Solutions Corporation
will provide meaningful, manageable, and defendable business management
software systems to the pharmaceutical, biotechnology, and medical
device industries.
Our systems will utilize state-of-the-art technologies to
promote efficiency, enhance understanding, and maximize effectiveness. Our
systems will be designed to help users comply with federal, state, and local
regulations, and meet accepted industry guidelines.
Customer service and support will provide each user with
consistently high levels of knowledge and technical expertise. Our
responsiveness will meet strict quality guidelines and exceed customer
expectations.
Compliance Software
Solutions Corp. (CSSC)
was incorporated in June of 1999 to serve the pharmaceutical, biotechnology,
medical device, food, and cosmetic industries by providing software tools and
support documents which enable the client to effectively monitor, control, and
if necessary, correct essential areas of control. The company is privately held
by the two founding principals, who collectively have over
35 years of
combined experience in the regulated health care industry (Management Team).
Our core application was the
Environmental Monitoring Software System (EMSS). It took several years to design and develop
before it was placed into beta testing at Jordan Pharmaceuticals in Elk Grove
Village, Illinois. From January 1999 until October 1999 it was refined, tested,
and validated before being introduced at the Parenteral Drug Association's
(PDA) Annual Meeting in December 1999. The environmental program provides a
cost effective and efficient means to assess and document facility operations,
collect microbial and/or particulate counts, and analyze and trend the data to
ensure that the environmental control systems are operating as intended. The
application was developed to meet the guidelines established by the PDA's
Technical Report 13,
Fundamentals
of an Environmental Monitoring Program.
CSSC has established licensed users
in the United
States, Puerto Rico, and Europe. Several of our users date back to our initial
introduction of the program in late 1999. They have successfully validated the
application and deemed it to meet their individual requirements for 21 CFR Part
11. CSSC has been successfully audited by a number of our current client
companies, as well as a number of third party validation companies on behalf of
our existing customers.
In January of 2004, CSSC introduced the next generation of our environmental
data management application. After nearly 2 years of design and development,
the Microbiology Information Management System (MIMS©)
was launched. The MIMS is the result of our success and experience to-date,
learned trends in the industry, and input from our current users.
The MIMS “suite” is comprised or four (4) separate, yet integrated software
applications – System Configuration, Environmental Processing, Reports,
and the Audit. In addition, there is a server application that runs as a
“service”, enabling the entire program to be installed in a manner consistent
with any facility’s IT architecture – either two-tier or three-tier.
The MIMS appearance is different than the EMSS. The MIMS is more intuitive than its
predecessor, and easier to navigate, manage and support. In addition, CSSC
has had a number of custom icons developed, to better visualize some of the key
functionality. The end user is provided with the ability to configure more of
the applications attributes, affording more “customization” and improved administration.
The MIMS makes use of many of the functional attributes typically encountered in Microsoft®
applications, such as “decision trees” to navigate to site locations, and “wizards”
to create worklists and reports.
In addition, the MIMS along with our
published patent now affords us with a more versatile platform
and unique market position from which
to build on. We are developing
interfaces that will integrate into current
operations and provide automated data
transfer from equipment in the microbiology
laboratory directly into the MIMS database,
thereby reducing the amount of data entry.
Planned interfaces include organism
identification systems, particle counters,
and air samplers. CSSC also has the ability
to develop custom interfaces on a project basis for equipment specific to a
particular company or facility. Additionally, a number of optional software
modules are being considered that are specific to tests being done in Microbiology and Chemistry.
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