EQMS

ENTERPRISE QUALITY MANAGEMENT SYSTEMS

&

ELECTRONIC QUALITY MANAGEMENT SYSTEMS

Sparta System, Inc Service

Enterprise Quality Management Systems should be configured to fit a company’s needs and workflows, and validated to ensure the configuration meets the requirements. If a company is not satisfied with their EQMS, it is often due to poor configuration. Globiox can reconfigure a poorly performing system to make it work for the company. Our services include:

TrackWise Software Suite

  • TrackWise Core Applications, through the latest released version
  • TrackWise QualityConnect (Inbound/Outbound Web Services)
  • TrackWise Coordinator and Import Utilities
  • TrackWise QualityView/ETL with Business Views
  • TrackWise Electronic Reporting – eMDR, eMDV
  • TrackWise Supplier Collaboration (Stratas)
  • TrackWise Digital (Cloud QMS)
  • Crystal Reports
  • TrackWise Training Manager
  • TrackWise Audit Manager
  • TrackWise Archive Utility

Validation

  • Validation Planning
  • Risk Assessment
  • Requirement Elicitation and Analysis
  • IQ/OQ/PQ/UAT script development and execution
  • Validation Summarization

Globiox is a proud implementation partner of Sparta Systems, Inc. Our experts are TrackWise® certified through Sparta Systems and are capable of accomplishing just about any task within Sparta Systems’ Enterprise Quality Management Systems (EQMS), TrackWise® and TrackWise Digital®.

Greenlight Guru Services

"TRUE QUALITY IS WITHIN REACH" could not better sum up the platform Greenlight Guru provides it's medical device customers. As a service partner of Greenlight Guru, Globiox is dedicated to ensuring a smooth, comfortable, and timely transition services to Greenlight Guru customers. We are a certified service partner of Greenlight Guru and strive to provide our mutual customers the BEST experience medical device eQMS systems have to offer!

Greenlight Guru provides customers with is a one-stop shop eQMS that features built-in templates for system processes, on-boarding, and training which includes assistance from their expert 'gurus'. Through our experience, we have found there are instances where customers require additional support in migration, implementation and / or customization of how a specific client intends to utilize the system and remain compliant for their geographic market. The Globiox team is here to assist Greenlight Guru customers. We can help to optimize the Greenlight Guru eQMS, and to ensure Quality teams follow compliance standards, understand / operate risk appropriately, and fully utilize the Greenlight Guru system without skipping a beat in day-to-day operations.

Greenlight Guru Software Service Offerings:

  • Migration/Implementation planning and protocol development
  • Document Migration to Greenlight Guru
  • Full module set up inside Greenlight Guru software
    • Risk Assessment
    • CAPAs
    • Document Control
    • Design Control
  • Process improvement/Process creation
  • System-wide administration
  • Outsourced Quality department
  • Quality Manual creation and review
  • Establish automated workflows
  • Training

Globiox is a certified service partner of Greenlight Guru. Our team of certified experts assist medical device customers with basic-to-complex migrations to Greenlight Guru's Electronic Quality Management System (eQMS).