Capabilities

Business Benefi ts & KPIs

• FDA Rule Management

• Flexible solution to implement UDI FDA rules

• Fast track implementation

• Flexible solution to add/modify new FDA required fi elds

• Create multiple templates to avoid data entry

• Wizard based step-by-step approach to interact with user for data entry

• Validation at each step to avoid any human errors

• Revision management

• Using Agile PLM for storing UDI data fi elds

• Revision management of Finished goods and UDI documents

• Bulk upload for migrating multiple UDIs at one time

• Auto-Creation of UDI and Change Order and association with Finished Good parts

• Auto transformation of HPL7 format

• Direct Submission to FDA using ESG

• Dashboards and Reports

• FAST track solution to meet aggressive deadlines

• Flexibility - to accommodate future FDA rules

• Simplicity - interactive solution for data entry of 50+ fi elds

• Improved Audit Readiness – to reduce Audit Risk

• Decreases time and cost - to keep track of UDIs

• Lower risk of human error - while submitting UDI to FDA

• Less Training – interactive and user friendly solution

xavor.com

With recent FDA compliance requirements for the unique device identifi cation system (UDI), Xavor’s UDI Solution enables medical device companies to accelerate their product cycles by reducing the time needed to manage certain information sent to the FDA’s Global Unique Device Identifi cation Database (GUDID).

Our Agile PLM UDI Solution:• Business Benefi ts & KPIs• Guides users while creating your Part/UDI number• Helps users enter large numbers of attribute data with a help screen to assist them• Electronically submits your UDI information to the FDA from Agile PLM

What Can Xavor’s UDI Solution Do For Your Business?

Headquartered in Irvine, California, Xavor has provided business and software consulting services to enterprise companies since 1995. Our Agile PLM team delivers products, services and apps to enhance adoption and extend productivity. We perform new implementations, data migrations, upgrades and process customizations focusing on the semiconductor, medical device and high-tech verticals.

About Xavor Corporation

Visit us at: xavor.com

Key Capabilities• Quick installation of wizard application for UDI data creation

• Easy confi guration of add/ modify fi elds and validation

• Confi gure new/modify data dependencies

• Templates

• Agile PLM for persisting UDI fi elds

• Agile PLM for revision management

• Bulk import

Key Benefi ts• Fast Track implementation

• Less risk of human errors

• Reduces time to bring UDI in system which increases cost & time effi ciency

• One database for storing UDI (Agile PLM)

Key Capabilities• Creating/maintaining multiple revisions in Agile

• Workfl ow management & signoff

Key Benefi ts• Capturing all design changes for each revision

• Capturing DMR information

• CFR 21 part 11 compliance

• Integrate product and UDI in Agile

Key Capabilities• Data Export to multiple FDA templates

• Data transformation to XPL7

• Dashboards and Reporting

Key Benefi ts• Data Export to different templates

• Data Review before submission

• Generating a XPL7 for submission

• Dashboards and reports UDI tracking

Key Capabilities• Direct UDI submission to FDA

• Make dynamic changes before submission

Key Benefi ts• Automatic submission

• Seamless integration

• Bulk submission

Device Identifi er (DI) Record Details.

Electronic submission results.

Customers must provide authorization to access their Submission page.

For pricing options, contact Xavor today!