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Operational Excellence

Ensuring quality and regulatory compliance while also delivering best-in-class, innovative medical devices has never been more important. Our Operational Excellence solutions enforce regulatory compliant manufacturing operations while enhancing the ability to define, schedule, execute and assure manufacture processes that optimize quality and efficiency. Additionally, our product analytics solutions provide proactive quality insights and decision-making support based on manufacturing and quality big data.

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Operational Excellence

Ensuring quality and regulatory compliance while also delivering best-in-class, innovative medical devices has never been more important. Our Operational Excellence solutions enforce regulatory compliant manufacturing operations while enhancing the ability to define, schedule, execute and assure manufacture processes that optimize quality and efficiency. Additionally, our product analytics solutions provide proactive quality insights and decision-making support based on manufacturing and quality big data.

How big data analytics drives operations excellence at your medical device company

Operational Solutions & Big Data Analytics

Operational Solutions & Big Data Analytics

Achieve operational excellence at your medical device company with our data-driven manufacturing solutions, ensuring quality and minimizing costs. Produce better devices while adhering to regulatory mandates for production controls and adapting to a complex, ever-changing marketplace.

Solution Capabilities

Explore the key areas of this solution.

Production Planning & Scheduling

Production Planning & Scheduling

Create detailed med device production plans for production orders, optimizing use of your manufacturing assets.

Production Order Management

Production Order Management

Respond flexibly to production orders, creating production workflows from templates for medical device manufacturing execution.

Inspection Planning & Management

Inspection Planning & Management

Include inspection operations in production workflows for quality assurance in medical device development.

Nonconformance Management

Nonconformance Management

When inspection operations identify medical device and equipment non-conformances, enforce resulting workflows for rework, scrap and quarantining.

Guided Manufacturing

Guided Manufacturing

Enforce proper sequencing of medical device manufacturing operations and accurately record material consumption.

eDHR / eBR

eDHR / eBR

Create the required regulatory records for discrete-manufactured medical devices as well as formulated products.

Label Printing

Label Printing

Print labels on-demand using production identifiers that are specific to the medical device, batch or lot.

Production DMR & Workflow

Production DMR & Workflow

Leverage graphic and written work instructions and medical device specifications as part of the efficient and enforced production workflow.

5M Enforcement

5M Enforcement

Incorporate 5M and Lean principles in defining workflows and quality assurance operations for medical device and equipment manufacturing.

Mfg & Quality KPI’s

Mfg & Quality KPI’s

Measure, report, and control key quality and production metrics at your medical device organization.

Shop Floor Integration

Shop Floor Integration

Communicate with various systems and platforms for advanced automation and increased efficiency in medical device manufacturing.

Containment Management

Containment Management

Identify and manage non-conforming materials in your med device business according to an approved disposition management program.

Performance Data Analytics

Performance Data Analytics

Drive improved medical device performance back into design, engineering and manufacturing by combining and analyzing big data sources within a single, integrated platform.

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Operational Excellence

The FDA and other regulators continue to emphasize mature quality assurance practices over baseline compliance activity. This heightened focus, referred to as the Case for Quality, along with globalization, economic factors, and a growing and competitive marketplace, are key factors driving Operational Excellence within the medical device industry. Similarly, greater device complexity and the increased occurrence of safety issues and recalls have heightened the need to enforce quality, efficiency and traceability in manufacturing operations.

Medical device organizations must produce devices using a digitalized manufacturing platform that provides production, supplier and purchasing controls. They must also take advantage of advanced big data product analytics to improve quality, reduce operational costs and mitigate risks.

Our proven Operational Excellence solutions deliver this critical functionality, enabling medical device organizations to excel.

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