Integrating the three modular elements—MES, LIMS, and eQMS— enable end-to-end traceability, ensure ALCOA+ compliance, and eliminate process silos.
To achieve operational excellence in pharmaceutical manufacturing, data integrity must be ensured across the three core GMP functions: manufacturing, quality control, and quality assurance. MES, LIMS, eQMS represent the key systems that support these functions—forming the triple pillars of data integrity.
Yokogawa’s Tri-Integrity establishes the ultimate data integrity and traceability framework that extends beyond individual systems.
This unified digital foundation enables faster, smarter decision-making, minimizes the cost of non-compliance, and enhances both productivity and quality in a highly regulated environment.
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Benefits
Better Decision Excellence begins by breaking down data silos between production, quality assurance, and quality control. Through integrated and shared information, organizations can enable consistent, data-driven GMP decision-making across the entire manufacturing lifecycle.
These improved decisions naturally lead to Batch Excellence. By eliminating data integrity risks caused by manual recording and fragmented documentation, manufacturers can accelerate batch production and validation while reducing errors and rework.
Building on this foundation, organizations can achieve Transformation Excellence. By embedding DX initiatives into on-site operations with appropriate validation and change control, sustainable digital transformation becomes possible—without compromising robust GMP compliance.
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OpreX Quality Management System
Manage, monitor, and control quality assurance processes.
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OpreX Laboratory Information Management System
OpreX Laboratory Information Management System（hereinafter "OpreX LIMS"） is a Laboratory Information Management System (LIMS) package, which supports quality management operations. Furthermore, it standardizes quality management operations to reduce costs and improve the service level.
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Manufacturing Operations Management for Pharmaceuticals
In pharmaceutical production, while the needs for pharmaceutical products are rapidly increasing, and manufacturing management is required to comply with laws and regulations, there is an urgent need for even higher quality and higher efficiency in order to survive in a severely competitive environment. Yokogawa is maximizing synergy between measurement, control, and information to meet the need for solutions to these issues.
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