® Mission
 ®  Why
 ® Practice
 ® Solution
 ® Advantage
 ® Utility
 ® Compliance
 ® Day to Day
 ® Added value

 

 

Mission

HCS, 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 a Flexible Machine Intelligence (FMI) platform for “shop floor-to-top floor integration"HCS technology is oriented to 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.

 

 

Why

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.

 

 

Practice

Many companies in the regulated industries are struggling through expensive, highly customized projects to meet the level of integration required between their production-control and facility-control systems.

 

 

Solution

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.

The HCS in-process-electronic-recording and measurement-taking, improves the accuracy and usability of collected data.

The HCS 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 problems.

The common platform also reduces costs associated with project engineering, training, documentation, and maintenance thereby simplifying and reducing the overall cost of regulatory compliance.

 

 

Advantage

The fact that HCS can provide common solution in accordance to a customized project is the differential advantage to many of its competitors.

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 the world.

 

 

Utility

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, HCS, 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 manner.

 

 

Compliance

HCS 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 electronic format.

The HCS Platform has been part of the scope of FDA audit many times, and our customers are very comfortable and confident in presenting their HCS Platform as a key tool to their electronic batch record implementations.

 

 

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.

 

 

Added Value

HCS 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.

HCS 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 screen menus.

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.

 

 

:: HOME :: PRODUCTS :: SERVICE  ::  CONTACT :: DOWNLOAD ::

  HCS division of Bettinelli F.lli S.p.A.,  all rights reserved