eQMS『QMSmart』
Utilizing AI to digitize documents, education, and quality events in a seamless manner!
"QMSmart" is a cloud system created by medical device manufacturers from a field perspective. With specialized AI, it assists in automatic checks for regulatory compliance of documents, creation of educational tests, and root cause analysis. It enables the transition from person-dependent management using tools like Excel, preventing oversight and expiration, thus achieving operational efficiency. 【Features】 ■ All documents and records are digitized, making revisions and approvals smooth ■ Visualizes and automates management of the progress and deadlines of quality events ■ Links education to SOP revisions and automatically accumulates training records ■ AI automatically checks compliance with regulations such as QMS ordinances ■ Automatically generates test questions for training ■ AI supports root cause analysis from quality information such as complaints *For more details, please download the PDF or feel free to contact us.
basic information
【Regulatory Compliance (Partial)】 ■Compliance with 21 CFR Part 11/ER/ES guidelines ■Audit Trail ■Electronic Signature ■Acquisition of ISO 27001/ISMS certification ■Access Control ■Free provision of CSV (Validation) *For more details, please download the PDF or feel free to contact us.
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For more details, please download the PDF or feel free to contact us.
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Started offering "QMSmart," an eQMS for medical device manufacturers, and an "AI Chat" that responds to their own QMS data.
As a major update, we will enhance AI quality event analysis that accompanies everything from root cause analysis to CAPA planning, full-text search using AI-OCR, and IP address restrictions. Berry Co., Ltd. (Headquarters: Taito-ku, Tokyo; CEO: Hiroshi Nakano) will start providing updates for its cloud-based eQMS "QMSmart" for medical device manufacturers from August 10, 2026. The core of this update is the enhancement of "AI chat," which answers based on the documents, records, and quality events of the implementing companies, and "AI quality event analysis," where AI accompanies everything from root cause analysis to CAPA planning. Additionally, we will simultaneously improve the utilization and control of QMS data through enhanced full-text search using AI-OCR and organizational-level "IP address restrictions."
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[August 21 Free Seminar] Evolved to this extent with AI! A thorough explanation of the basics and latest updates of eQMS "QMSmart"
Berry Inc. (Headquarters: Taito-ku, Tokyo; CEO: Hiroshi Nakano) will hold a free online seminar titled "Evolved with AI! - A Comprehensive Explanation of eQMS 'QMSmart' from Basics to Latest Updates," which will explain the overall picture and latest updates of the cloud-based eQMS "QMSmart" with a live screen demo, on August 21, 2026 (Friday) from 14:00 to 15:00. This seminar is aimed at those considering the introduction of eQMS, as well as quality assurance, design development, and manufacturing personnel at medical device manufacturers who feel limited by paper and Excel-based QMS operations, as well as management. Participants will be able to see the evolved QMSmart in its entirety in one hour, following this summer's major update.
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Berry Co., Ltd. is a medical device manufacturer that produces and sells cranial shape correction helmets for babies (Class II medical devices). We provide an app that makes it easy to record and manage helmet treatment, as well as an information platform to support medical device manufacturers in addressing regulatory compliance and QMS (Quality Management System) challenges. Additionally, we offer an AI-equipped eQMS developed to solve issues in QMS operations, aiming to contribute to the advancement of medical device manufacturers and, ultimately, the medical device industry through the digitalization of QMS.