Dataworks Client Achieved Significant Improvements in Efficiency, Quality and Compliance with MES Works
Customer Challenge
Our client, a large multinational medical technology company, had a paper-based device history record (DHR). Tracking “critical to quality” information manually was time-consuming, open to human error and laborious to review. Recognizing the need for a more streamlined and efficient solution, the company sought to digitize and optimize their DHR process.
Dataworks Role
Dataworks, renowned for its expertise and pedigree in delivering innovative solutions, was engaged as the software development partner. Our task was to develop an electronic DHR system based on our proven MESWorks platform.
The Solution
MESWorks helped build greater control into the manufacturing and quality review processes by digitizing and optimizing the data capture process. Routing, Bills of Materials (BOMs) and product testing were all digitized helping embed quality into the process and also guiding product builders along standardized paths.
All transactions were fully audit trailed and electronic signatures supported, ensuring compliance with regulations such as 21 CFR Pt. 11. Many logbooks and test sheets were also digitized and incorporated into the MES system.
The system enabled real-time tracking of performance metrics, serving as a vital data source for continuous improvement projects. By providing actionable insights promptly, the company could address issues proactively.
The site experienced a reduction in Corrective and Preventive Actions (CAPAs) and Non-Conformances, yielding significant time savings and reduction in Work Order completion times.
Implementing MESWorks facilitated the progression of the sites Digital Maturity Level by interfacing with the company’s ERP system, Learning Management System and Document Management System.
It has been a key enabler for many Continuous Improvement projects at the site.
Technology
The solution uses Microsoft SQL Server as the database with a web-based User Interface. Implementation was conducted in phases across the different manufacturing and packaging areas to ensure the smooth transition from paper to digital.
Core Business Benefits
- Operational and Quality Improvements: With a more robust DHR system in place, the company experienced an improvement in the flow of products and reductions in WIP. The digitized routings, material scanning, and capture of critical parameters and product test data led to improved quality across the production process.
- Cost Savings: The transition from a paper-based system to an electronic one resulted in significant cost savings. Reductions in compliance costs, human errors, batch review times and paper usage throughout production contributed to improved operational efficiency and bottom-line savings.
- Real-Time Tracking: The Real-time recording and tracking capabilities of the system empowered the company to identify and address issues promptly. It also supported the recording and monitoring of KPIs across the Operations and Quality functions, eliminating time spent collecting, collating and presenting this data across all tiers of the organisation. This helped the site with their Visual Management and Continuous Improvement strategy.
“By partnering with Dataworks, we achieved substantial improvements in efficiency, quality, and compliance. The solution not only addressed the challenges posed by our old manual processes but also gave us a
platform to become a more data driven organisation”.
– Operations Director.
Contact Us
Contact us to learn more about the detail of this project and others that we have delivered to address the issues of data accuracy, time and visualisation when using Excel and paper-based processes.
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