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 o​f dollars by eliminating additional licensing fees.

Slide2

A compliance initiative gives you the opportunity
to digitize your quality assurance process and
reduce labeling costs.

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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.

Senior IT Architect,
Supply Chain Applications

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.

Senior IT Architect,
Supply Chain Applications

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.

IT Systems Administrator

Find out how much your company could save by
digitally transforming labeling.

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Explore related stories

Our goal is to have a zero-error environment, and NiceLabel’s Label Management System plays a big role in that. We can already see the positive impact the system has had on our productivity and transparency, and we expect that those benefits will only increase over time.

Michał Mydlikowski,
Logistics Manager

Read success story

As part of their compliance effort this company was able to reduce costs related to label design and approval, production downtime, mislabeling and IT maintenance.

QA Manager,
The Customer

Read success story

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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.

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