Sagami Ohi Plant, Wakamoto Pharmaceutical Co., Ltd.
Wakamoto Pharmaceutical has contributed to the creation and development of a healthy and prosperous society through the research and development, production, and supply of pharmaceuticals.
In addition, we are promoting the creation of products using the latest equipment and state-of-the-art technologies, such as the addition of an eye drop line, which has been our main focus in recent years, and are focusing our efforts on further improving reliability with the goal of achieving quality assurance which is the evolution of quality control.
Introduction Background and History
"When introducing the quality control system this time, we aimed to automate and improve the efficiency of our quality control operations. In fact, we felt that because the existing production management system used printed documents and computers together and left the "culture of paper" intact it was extremely wasteful. Therefore, this time, we wanted to depart from the concept of "current operations" as much as possible and take root in "IT culture," says Mr. Kirigaya, Director-General of the Information Systems Division, Head Office and Information Systems Department.
Specifically, we aimed to realize the following issues of the Quality Control Division: automation and optimization of quality control operations, which were centered on manual operations; support for computer validation accompanied by automation; elimination of input errors and transcribing mistakes which compromise reliability of data; inheritance and accumulation of know-how through standardization of operations; response to external requests for data disclosure, including business partners; progress management of a large number of tests and inspections; and statistical analysis of data in real time.
Mr. Kawano, head of Quality Control Division 2, who has been working on and promoting the project, said "we searched for a system that is easy to use and fits the actual circumstances of the Quality Control Division which works in a narrow space. As a result, being able to input data using portable terminals was a key factor to choose the system. With the introduction of the system, we wanted to be able to track the records back in the past. In addition, when the number of sample quality test items is large and each person is involved individually, there was a lack of efficiency in making final decisions after writing down test results on paper. By enabling near-simultaneous inputting of data and immediate decision result checking, we aimed for centralized management of data. The introduction of this LIMS is just one of the ways to control quality. The goal is to take it one step further to "quality assurance."
In the case of the Sagami Ohi Plant, we realized system construction with a clear policy of "adapting the operation to the package."
Mr. Kawano said about the current situation, "Because it was our first system introduction, we wanted to use the standard functions of the packages to change the way the quality control works at the site. In operations, we want to become more familiar with how to use them and then evolve them further. In addition, we were able to realize a very efficient work environment by inputting and searching data using PDAs in a limited space at the site."
Mr. Funatsu said, "There were many requests from the tester regarding their way of inputting data. The main challenge was to relate the connection between them, but we received advice from Yokogawa's SE and realized the standardization of the input method.
They responded to various problems many times in the form of Q&A." Mr. Tsuyuki said, "We were unfamiliar with the system so most concerned about system operation after starting system operation. At that time, Yokogawa's engineers supported us in a friendly manner and made various measures to solve our concerns."
Solutions Through LIMS (standardization and streamlining of quality-control operations)
- Solved work problems in narrow spaces using portable terminals
- Significantly improved work efficiency by integrating data from analytical instrument online
- Prevented mistakes via barcode sample management
- Improved data reliability by eliminating typographical errors and transcribing mistakes
- Centralized database management for free data retrieval and trend analysis
- Realized traceability. Prompted response to internal and external inquiries
- Reduced data collection time lag between various reagent tests
"When I looked back on our relationship with Yokogawa's SEs, I thought, 'I want to work with these kinds of members again,'" says Mr. Tsuyuki.
Mr. Kirigaya mentioned the aspiration, looking forward to further progress, "The introduction of this system became one successful model, and the feeling of anxiety about using the system in the plant was eliminated, raising the motivation for work improvement.
In the future, we would like to realize a synergistic effect by, for example, utilizing the know-how of this project to promote the development of company-wide information systems, and linking systems when considering the next generation of production management systems."
Related Products & Solutions
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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