ENTERPRISE-WIDE DIGITAL COMPLIANCE AND OPERATIONAL EXCELLENCE

FOR THE MEDICAL DEVICE INDUSTRY

Growth of the medical device industry is driven by multi-faceted scientific innovation, broader and deeper diagnostic capabilities and an expanding global reach. Along with expansive growth comes the challenge of managing evolving regulatory requirements.

Dassault Systèmes BIOVIA delivers a comprehensive quality solution for enterprise excellence that meets today’s growing global regulatory challenges while also reducing the effort required to document scientific activities with improved detail, accuracy and speed.

Enterprise-wide Digital Quality and Compliance Enterprise-wide quality and compliance practices allow organizations to automate processes across sites and projects. The result is faster commercialization of new products and fewer complaints and observations against existing products. Unified compliant processes make it possible to incorporate new and updated regulations efficiently—and at half the time and cost.

Unified Lab Approach to Operational ExcellenceTo achieve enterprise excellence with a comprehensive approach to quality, digital initiatives must also include additional quality-related spaces like laboratory and manufacturing testing. BIOVIA’s comprehensive Unified Lab Management solution leverages the latest technology innovations to integrate people, resources, processes and data, supporting seamless collaboration within and between organizations for improved efficiency, quality and compliance.

TRANSFORM QUALITY, COMPLIANCE AND OPERATIONAL EXCELLENCE

Companies adopting the BIOVIA Quality and Unified Lab solutions have realized value across a range of activities.

Digital Quality and Compliance Best Practices ↑ 85% improvement in data traceability ↓ 50% reduction in FDA on-site inspection time ↓ 20-30% in observations ↓ 10-20% in deviations ↓ 10-20% in CAPAs

Global Operational Efficiency ↓ 16% or more reduction in time-to-market ↑ Global site compliance ↓ Site-specific idiosyncrasies

BIOVIA BENCHMARK METRICS

STANDARDIZE QUALITY AND COMPLIANCE PRACTICES

Suppliers

RemoteSite

RemoteSite

RemoteSite

RemoteSite

RemoteSite

ANDA/NME

FDA

Customers

Simple record of truth:quality, regulatory, compliance

Single global enterprise wide Quality Management System

Easily develop global automated workflows

Improve employee productivity and satisfaction Non-Compliance Management

Complaint Management

Regulatory

Regulatory

Speed time to market with less errors and decreased processing time

BIOVIA’s enterprise-wide approach streamlines and standardizes quality and compliance practices, allowing organizations to easily automate processes across sites and projects.

A UNIFIED LABORATORY TESTING SOLUTION

PLANNING & SCHEDULING LAB EXECUTION REPORTING

& APPROVAL

ManagementAdaptation

Development

InventoryPurity

GenealogySpecifications

OriginSafety

RequirementsControls

DocumentationTracking

METHODS

MATERIALS LIFECYCLE MANAGEMENT

COMPLIANCE

Submissions

APPROVED

REQUEST

BIOVIA’s science foundation redefines the future of pharma and medical device development and manufacturing. Our comprehensive application portfolio leverages the latest technology innovations and has a proven adoption success record. Unifying lab solutions is a first step toward promoting seamless collaboration among organizations.

• Increase speed to market by simplifying regulatory approvals

• Propagate quality best practices across global organization

• Provide pathway to resolve internal conflicts

• Unlock the information that drives innovation, improve collaboration

Strategic Benefits• Reduce roll-out cost to new

sites/organizations

• Streamline processing of Engineering Change Notices

• Reduce audit/certification costs

• Reduce CAPA-related overhead

• Decrease lab testing time and product launch costs

Economic Benefits

Risk Mitigation• Provide single record of truth

• Improve timely response to customer complaints

• Reduce number of deviations/observations

• Improve data traceability

• Reduce on-site FDA inspection time

IT Impact• Replace custom implementation

with configuration

• Improve end-user adoption

• Reduce administrative burden

• Simplify IT landscape with reduced IT development/maintenance costs

Medical device companies can improve collaboration across sites, globalize quality best practices, simplify compliance and achieve operational excellence by deploying a packaged Quality and Unified Lab Management solution from BIOVIA that accelerates implementation, drives collaboration and lowers risks.

THE CASE FOR CHANGE

Now more than ever, medical device organizations need a trusted, strategic partner that shares their vision and passion for what is possible in today’s rapidly changing environment. Dassault Systèmes BIOVIA offers unparalleled experience and a strong track record in the pharma industry to assist medical device companies on their business and IT transformation journey.

We look forward to supporting medical device companies with overall project development, design and deployment to accelerate their transition from evaluation to implementation of an industry-leading Quality and Unified Lab Management solution.

THE VALUE OF PARTNERING WITH BIOVIA

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Our 3DEXPERIENCE® platform powers our brand applications, serving 12 industries, and provides a rich portfolio of industry solution experiences. Dassault Systèmes, the 3DEXPERIENCE® Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported. Dassault Systèmes’ collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world. The group brings value to over 190,000 customers of all sizes in all industries in more than 140 countries. For more information, visit www.3ds.com.

Dassault Systèmes CorporateDassault Systèmes175 Wyman StreetWaltham, Massachusetts02451-1223USA

BIOVIA Corporate EuropeBIOVIA 334 Cambridge Science Park,Cambridge CB4 0WNEngland

BIOVIA Corporate AmericasBIOVIA 5005 Wateridge Vista Drive,San Diego, CA 92121USA

The next step is to develop a strategic business partnership with BIOVIA aimed at deploying an enterprise-wide digital Quality and Unified Lab Management solution that enhances operational excellence, drives collaboration, lowers risk and accelerates innovation to market.