ナラサキ産業 メカトロソリューション部　機能材料課 Official site

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 integrated into the system and provided. (Compliant with 21 CFR Part 11) - We are responding to projects using GENESIS64 in accordance with business flows that comply with GMP regulations for CSV. - After receiving an order, we manage the requirements with the customer using a traceability matrix to ensure there are no discrepancies. - The SCADA system using GENESIS64 has numerous achievements not only in the pharmaceutical industry but also in various other fields. *Traceability Matrix: A tool for managing how the requirements of the URS are reflected and how the results are verified.

GENESIS64 is a SCADA software adopted in factory automation lines and the construction of social infrastructure systems 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 works across various devices, 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. - Construction of high-speed data collection and highly reliable systems (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 integrating with other IT tools and analytical applications, enabling OEE, SPC, energy management, and more. * OEE: Overall Equipment Efficiency / SPC: Statistical Process Control

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) - Establishes 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 completion of each process. - Validation specifically focused on computerized systems.