Factory Management System "MENTENA" Supports GMP Compliance for Pharmaceutical and Food Manufacturers, Launches "GMP Lite" to Reduce Burden of Documentation and Change Management

Yachiyo Solutions Corporation (Head Office: Taito-ku, Tokyo; President: Takashi Mizuno; hereinafter "Yachiyo Solutions") has launched "GMP Lite," a GMP compliance support option for its factory management system "MENTENA." This new offering aims to assist with the preparation of compliance documents and change management tasks during the implementation of facility management systems, driven by the increasing need for GMP (Good Manufacturing Practice) compliance in the pharmaceutical, food, and cosmetic manufacturing industries.

Background of the Offering

In recent years, the pharmaceutical industry has seen a series of administrative actions due to quality control deficiencies, raising concerns about the stable supply of medicines as a social issue. In this context, preventing production stoppages caused by quality fraud or inadequate management systems and ensuring a stable supply of pharmaceuticals to medical sites have become critical social challenges for the entire industry to address.

Furthermore, starting September 2024, manufacturing management based on GMP will be mandatory for functional foods in supplement form, with full implementation scheduled for September 1, 2026, after a two-year grace period. Additionally, specified health foods (Tokutei Hokenyo Shokuhin) have always required appropriate manufacturing and quality control systems. Consequently, the establishment of quality assurance systems is becoming urgent not only in the pharmaceutical industry but also in the manufacturing sites of food and supplements.

However, many companies face several hurdles when introducing facility management systems, including the difficulty of preparing the necessary GMP-compliant documentation, the inability to complete system evaluations solely in-house, and the recurring need to verify GMP compliance with every system update.

GMP Lite was developed as an option based on consultations with clients in the pharmaceutical and food industries who inquired about "how to ensure GMP compliance."

Overview of GMP Lite

GMP Lite is a service that supports GMP-compliant operations while utilizing the standard functions of MENTENA. We provide standard service specifications and other documents, accompanying clients through their compliance processes.

Data Integrity Implemented as Standard

Audit trails that record "who, when, and what" was done, along with role-based access control, are implemented as standard features. These functions help clients build a highly reliable data management system that can withstand inspections.

Information on Change Management

We provide advance notification for significant functional changes and offer information for impact assessments on GMP compliance. This aims to reduce the burden of re-evaluation and change management for our clients, ensuring they can continue to use the system with peace of mind.

Safe Operational System

By utilizing highly durable cloud storage and establishing robust data backup and disaster recovery systems, we support the preservation and continuous use of critical facility management data.

Acquisition of ISMS Certification

We have obtained ISO 27001 (ISMS) certification, an international standard for information security, ensuring our security management system for the cloud infrastructure and development processes. This helps reduce the effort clients spend on "vendor evaluations" and system verification.

It is important to note that the final evaluation of GMP compliance and the execution/judgment of various validations (IQ/OQ/PQ, etc.) are the responsibility of the client, and GMP Lite is a service that supports this process.

GMP compliance is not just an issue for quality assurance departments; it is a management challenge for manufacturing industries. Amidst a severe labor shortage, there is a growing need to establish systems that ensure legal compliance while maintaining production activities and enhancing corporate competitiveness.

MENTENA has been supporting the resolution of all challenges faced by manufacturing sites through the DX of facility management. GMP compliance is one of these initiatives, addressing the areas of quality control and legal compliance.

We will continue to improve our services based on customer feedback and support the dual goals of improving productivity and ensuring quality assurance across the entire manufacturing industry.

About the Factory Management System "MENTENA"

URL: https://mentena.biz/

MENTENA is a factory management system designed to minimize unexpected equipment downtime in manufacturing. By centralizing equipment management tasks such as inspection, maintenance, and repair, and moving away from paper-based or Excel-based, individualized work processes, it achieves efficiency in site operations and reliable history management. With an intuitive design that anyone can use, and a support system that assists from implementation to adoption, it realizes "easy," "easy to start," and "reliable support," contributing to stable factory operations. This service is utilized in factory and facility management operations across various sites, including manufacturing, building maintenance, and the gas and electricity industries. It helps establish preventive maintenance while minimizing the burden on site staff, preventing losses from unexpected downtime and equipment aging, and accumulating facility management data in a format that can be used for management decisions, thereby contributing to the coexistence of stable site operations and sustainable business growth.

About Yachiyo Solutions Corporation

Yachiyo Solutions Corporation was established to realize the formation of sustainable local communities and the long-term growth of companies, by leveraging the knowledge and experience in social infrastructure management cultivated by its parent company, Yachiyo Engineering Co., Ltd., over more than 60 years. As our clients' foremost partner, we emphasize the creation of mechanisms that serve as a "common language" connecting the site to management, through asset management that utilizes data as an asset. We view data not merely as records but as "assets that support decision-making," and by continuously refining it into practical solutions, we contribute to improving the quality and speed of our clients' decision-making. As the first initiative in this endeavor, we are primarily deploying the factory management system MENTENA.

Company Name: Yachiyo Solutions Corporation

Location: 5-20-8 Asakusabashi, Taito-ku, Tokyo

Representative: Takashi Mizuno, President

Website: https://yachiyo-sol.com/