Global dental device manufacturing company discovers an Oracle integration alternative that reduces licensing and implementation costs while delivering compliant labeling
Challenges
- Manual labeling created non-compliance risk
- Limited integration options
- Escalating production set up costs
- Inefficient processes drove up costly man hours
Solutions
- Approval workflows enable compliant labeling
- Tracking and audit capabilities
- Workflow engine and business rules
Results
- Achieved compliance
- Reduced impact to the bottom line
- Reduced implementation time
- Avoided tens of thousands in additional licensing costs
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Results in numbers
< 100
man hours
Streamlined label design and approval processes saved company hundreds of man hours per year.
> 10k
dollars
The company saved tens of thousands of dollars by eliminating additional licensing fees.
Slide2
A compliance initiative gives you the opportunity
to digitize your quality assurance process and
reduce labeling costs.
Background
This dental product manufacturer is an international leader in the industry with a 30-year history of innovation and quality. In keeping with its mission to improve the level of dental health care worldwide, the Company markets its products through distributors in more than 100 countries, reaching individual dentists, dental schools, and labs. It manufactures and packages more than 500 materials, devices and instruments. The Company is certified to market dental products in Europe, under the International Standards Organization 9002 requirements. It also meets U.S. Food and Drug Administration (FDA) requirements.
Existing Label Printing Environment
The Company used a legacy third party labeling solution and Oracle E-Business Suite. Label design software was installed on individual desktops that were each connected to a printer.
Business Goals
The Company’s business goals focused on regulatory compliance while driving operational efficiencies. They also needed an integrated labeling solution that leveraged existing Oracle business flows.
| Industry: | Dental |
| Solution: | NiceLabel LMS |
Challenges
Non-Compliance Risk
The Company needed to comply with multiple regulations including FDA 21 CFR Part 11, Part 820 and UDI as well as ISO 9001 and 9002. The existing legacy solution required manual processes which introduced an increased risk of errors leading to mislabeling and non-compliance. The Company needed to comply with industry regulations without adding complexity to print processes.
Manual Label Approval Process
The Company’s existing labeling software didn’t have version control or approvals making it difficult to approve labels in accordance with FDA compliance guidelines.
Limited Integration Options
The Company uses Oracle E-Business Suite as their SCM solution. The Customer initially believed there wasn’t an alternative to the incumbent’s Oracle Connector bi-directional integration technology to write print job status back to Oracle tables. They needed an alternative to the expensive Connector while maintaining detailed label request history.
Escalating Production Set Up Costs
The rigid competitive print server simply merged XML data and executed print jobs. Label adjustments and printer settings couldn’t be changed at the individual printer level or at print time. Instead, they had to be set during the design stage for all printers which resulted in costly production setup. The Company also couldn’t create business rules or workflows without adding the costly Connectors to the legacy print server.
Inefficient Processes
Warehouse and work in progress (WIP) labels were generated from standalone labeling stations during the receiving process and were filled out by hand resulting in costly man hours and increased the likelihood of errors.
The incumbent provider required additional middleware and infrastructure to deliver the level of integration we needed.
Solution
Assured Compliance
The Company now has complete centralized control over label design and printing. Human error and mislabeling are no longer an issue and labeling processes are consistent. The NiceLabel Label Management System (LMS) provides an approval workflow allowing the company to print labels in accordance with FDA 21 CFR Part 11 and Part 820 requirements.
Tracking And Audit Capabilities
The Company determined that while they needed to store print job status, they didn’t need it stored in Oracle. This allowed them to consider a much simpler, faster and more cost effective solution. NiceLabel’s LMS provides comprehensive print job tracking and superior audit trail and print history at a much lower cost than the incumbent’s proposed Connector and legacy print server solution.
Business Rules And Workflows
NiceLabel’s Automation module acted as an all-in-one next generation 64-bit labeling service bus, eliminating the need for additional connectors to configure business rules and print workflows. Warehouse users can now scan products and request labels to be printed from mobile devices through an Oracle interface; increasing efficiency, printing faster and eliminating mislabeling errors.
Streamlined Processes
NiceLabel provided products and integration that streamlined label warehouse and WIP label generation. The Company now enjoys new levels of operational efficiency while at the same time improving accuracy.
NiceLabel offered an all-in-one cost effective way to create business rules, print labels direct from Oracle and track print job status to support our global compliance initiatives.
Results
Achieved Compliance
The Company no longer needs to worry about penalties associated with non-compliance or product recall concerns.
Reduced Operational Costs
Reduced production setup times have resulted in more production uptime saving significant dollars each year. Because label design and approval processes are streamlined, the company is saving hundreds of man hours per year. Implementing the NiceLabel platform has produced operational efficiencies that have reduced impact to the bottom line.
Reduced Implementation Time
In the end, the Company only implemented one solution saving many hours of implementation time. Plus, the Company can now integrate with all Oracle modules when needed without spending time on creating additional integration triggers or filters.
Lower Licensing Costs
Because the Company didn’t need the incumbent’s Connector technology to integrate with Oracle for print job status, they ultimately eliminated tens of thousands in additional licensing investment.
Implementation of the NiceLabel solution was extremely smooth. We were up and running in less time that we had originally planned.
Find out how much your company could save by
digitally transforming labeling.
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Dental Device Manufacturing Case Study
Learn how a global dental device manufacturing company discovered an Oracle integration alternative that reduced licensing and implementation costs while delivering compliant labeling.