Globiox's team of experts can assist you in nearly every facet of the simplest paper based quality management system (QMS) to the most advanced enterprise quality management system (eQMS). Our clients include Fortune 500 companies and start-ups alike. We have expert staff to handle it all in a mutually agreeable scope. Gone is the time when you were forced to implement more than you could handle. Our team ensures the steps you take now will be scaleable for your future business.

QMS

Quality Management Systems are required for all FDA regulated entities, whether GMP, GLP or GCP. Some parts of the QMS are fairly straightforward, easy to develop and implement, whilst some require deep expertise. Even startups require some degree of Quality Assurance and Quality Management Systems and it takes an expert to tailor a QMS system for a startup. Globiox has a vast amount of experience in developing and “right-sizing” QMS to meet the needs of start-ups, GMP manufacturers, GxP Contract Research Organizations, GLP Pre-clinical laboratories, GCP CROs, GCP clinical sites, IT departments, virtual GxP companies, GxP software and mobile device developers, and suppliers to the FDA-regulated industries. Globiox also performs audits to ensure that the QMS is followed and is effective. Globiox has expertise responding to and performing remediations for FDA 483s and Warning Letters that have resulted from inadequate QMS. Our services include:

  • QMS Development
  • Implementation
  • Audits
  • Staff Augmentation
  • 483 and Warning Letter responses
  • 483 and Warning Letter remediation

eQMS

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
  • 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

Business Processes

  • Complaint, Pharma (with Investigation, CAPA, Change Control sub-processes)
  • Complaint, Medical Device (with Product Investigation, Good Faith Effort, Complaint/Medical Review, Assessment, Action, Manufacturer Notification, Regulatory Reporting and Electronic Submission sub-processes
  • Deviation (with Investigation, CAPA, Effectiveness Check, Change Control sub-processes)
  • Nonconformance (with OOS, Investigation, Correction, CAPA, SCAR sub-processes)
  • Audit, Internal and External (with Observation, CAPA, Change Control sub-processes)
  • Supplier Management
  • Training Management

Validation

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

Globiox is a proud service partner of Sparta Systems, Inc. Our experts are Trackwise® certified through Sparta Systems and are capable of accomplishing just about any task within Trackwise® and Trackwise Digital®.

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