Would you like to visualize your company's production and manufacturing line with GENESIS64?
We will handle everything from the design of systems compliant with DI (Data Integrity), including the creation of documents such as IQ and OQ, to CSV compliance. 【Equipped with standard functions required in pharmaceutical production and manufacturing sites】 - We have developed standard components that enable audit trails and user management in GENESIS64, which are incorporated into the system and provided. (Compliant with 21CFR Part 11) - We are responding to projects using GENESIS64 in accordance with the business flow that complies with GMP regulations for CSV. - After receiving an order, we manage the requirements with a traceability matrix to ensure there are no discrepancies with the customer. - The SCADA system using GENESIS64 has numerous achievements not only in the pharmaceutical industry but also in various other fields. *Traceability Matrix: A tool to manage how the requirements of the URS are reflected and how the results are verified.
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basic information
GENESIS64 is a SCADA software adopted in factory automation lines and social infrastructure system construction around the world. 【Features】 - A visualization tool that centrally manages data from FA (production sites) and IT (such as MES and ERP). - Supports monitoring via web browsers and apps, enabling the construction of a monitoring system that is device-agnostic, including PCs, tablets, smartphones, and wearable devices. - Compatible with 3D models and AR, allowing for the creation of diverse monitoring screens. - Supports industry-standard open protocols such as OPC and MODBUS, enabling easy connection with various devices and read/write capabilities with various general-purpose databases. - Management can be performed from the entire system down to individual equipment and devices, achieving efficient system operation. - High-speed data collection and the establishment of a highly reliable system (server redundancy). - Data accumulated on the server can be output in flexible formats for reporting. - Capable of analyzing large volumes of data with various functions and can integrate with other IT tools and analysis applications, enabling OEE, SPC, energy management, and more. * OEE: Overall Equipment Effectiveness / SPC: Statistical Process Control
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Applications/Examples of results
1. Compliance with Part 11 (21 CFR Part 11) - Supports electronic signatures, electronic records (storage), investigative authority (personal authentication), audit trails, electronic approvals, etc. 2. Compliance with CSV (Computerized System Validation) - Establish a full-scale production monitoring system using SCADA systems, rather than simple monitoring functions (GOT). - A system that not only remotely monitors the operational status of equipment but also issues production instructions for each process and collects and accumulates actual data after the process is completed. Validation specifically focused on computerized systems.
Company information
Narasaki Sangyo Co., Ltd. "Functional Materials Division" specializes in high-performance material contract processing. The materials we handle fall into "five categories": 1. Ceramics/Glass 2. Metals 3. Engineering Plastics 4. Carbon 5. Surface Treatment We offer a wide range of services, and if you provide us with a single production drawing, we can deliver various materials and surface treatments as a one-stop solution. We cater to everything from general-purpose to specialty materials, including high-precision, fine, electrical discharge, laser processing, as well as surface treatments such as coating, precision cleaning, and blasting. Our particular strength lies in high-precision and short-lead-time processing of ceramics. By machining from pre-fired materials, we achieve short lead times for ceramics that traditionally take several months. We handle a wide range of ceramics, including machinable ceramics like Hotovel, as well as fine ceramics such as alumina and zirconia, and non-oxide ceramics like silicon carbide, silicon nitride, and aluminum nitride. We are also actively engaged in proposing cost reductions for overseas ceramics and other international materials. We can accommodate various contract processing projects, from prototype development starting with a quantity of one to mass production.