an acronym for Hardware Components and free Software,
is a division of BETTINELLI F.LLI S.p.A and our mission
is to provide companies in the regulated industries with
Flexible Machine Intelligence (FMI) platform for “shop
technology is oriented
extract information directly from shop floor machines with the
capability to seamlessly link to any number of machines for
real-time data exchange between factory floor and management
enterprise systems. This "new visibility" will greatly enhance
decision-making processes, driving improvements in
manufacturing performance, quality and efficiency.
Regulatory compliance has generated a near-revolution in
facility control system technology. Regulatory agencies, such as
the FDA in the U.S., are seeking a close interface of production
and facility systems for both data exchange and control.
Regulatory compliance and site inspections are simplified when
facility control systems share manufacturing- environment data
with production-control-systems data which produce a single
electronic system of record.
During a site inspection, regulatory auditors often expect
companies, in the regulated industries, to produce specific
historical data regarding the manufacturing environment
experienced during a particular batch within a short time frame,
often as little as minutes.
Without the capability of facility-control-systems to share this
data with production-control-systems and store the data in a
common set of batch records, it is often hard or impossible to
find and produce this data in such a short time frame.
companies in the regulated industries are struggling through
expensive, highly customized projects to meet the level of
integration required between their production-control and
By providing customers in regulated industries a common platform
solution, capable of managing both production and quality
control, users can get an accurate view of processes with
instant access to real-time and historical data; can than
quickly analyze production performance on multiple manufacturing
paths along with specific equipment performance.
in-process-electronic-recording and measurement-taking,
improves the accuracy and usability of collected data.
customizable visualization System displays and delivers critical
data to standard desktop computers, to handheld devices, or to
other plants around the world via the Internet.
Authorized users can access process information anytime,
anywhere; the result is better-quality products and fewer
The common platform also reduces costs associated with project
engineering, training, documentation, and maintenance thereby
simplifying and reducing the overall cost of regulatory
fact that HCS can provide common solution in accordance to a
customized project is the differential advantage to many of its
Because of the global nature of the industry and the harmonizing
effort of their regulatory agencies, pharmaceutical companies have
begun to standardize across all of their manufacturing sites. By
designing a library of pre-defined object types for customers to use
during the deployment of the solution, HCS not only reduces
the effort required of its customers to validate regulatory
compliance, the company also provides customers a standard solution
that is highly scalable across many manufacturing sites throughout
Online diagnostic capabilities also provide companies in the
regulated industries a means to maximize asset utility and
production capacity by monitoring key assets online and
identifying potential failures and other undesirable conditions
before they occur.
By combining the ability to provide both production and facility
control using a common platform and maintaining a standard
library of pre-defined object types with all versions, release
processes, and audit trail requirements,
by means of its hardware components and free software, has gone
a long way toward achieving a reliable cost effective platform
with expandable architecture easy to maintain in a compliant
Platform powered by the MONITOR, DAQ and STAT Software which
are completely compliant with the FDA' s 21 CFR Part 11
requirements for the collection and storage of data in an
Platform has been part of the scope of FDA audit many times,
and our customers are very comfortable and confident in
Platform as a key tool to their electronic batch record
Day to day
As consolidation of medical appliance companies and their
manufacturing capacity continues unabated, several well-known
performance indicators are getting more attention from the
managers of day-to-day operations.
One of those is OEE, Operating Equipment Efficiency, a
performance measure of machinery on a manufacturing line that
attempts to identify specific elements in the system that cause
the greatest share of disturbs. The challenge with these
measures is that to be of real value, the analysis must also be
able to differentiate between events within the machine. On a
high-speed assembling machine the most information management
tools can't do the job.
hardware components and free software are ideally designed for
capturing in-process control data and performance data on a
high-speed assembling line, providing the means of determining
the true source of the problem out of traditional mundane
activities like having to scroll through pages and pages of
reports, selecting and distributing data, a time-consuming and
frustrating exercise which now can run directly at the source
with real time electronic reporting.
MIT, Machine Intelligence Technology, offers to operators,
supervisors, plant management, and up-level executives the
benefits of improving manufacturing visibility, batch analysis
and operational performance through personalized, pre-configured
The System incorporates analytical capacity and data warehouse
that captures, transforms and unifies real-time, historical and
running data collected directly during machine production
activities. This can be performed from a single or
multi-machines environment into a single contextualized database
to maximize enterprise-wide efficiencies, to improve operations,
to identify best practices in PBDA, Post-Batch Data Analysis,
product traceability and driving market responsiveness.