Globiox
Globiox is a leading quality assurance firm specializing in the life sciences industry, providing comprehensive compliance and technology services. With a focus on regulated industries, they offer services including GxP auditing, TrackWise Digital implementation, regulatory strategy, and training. Globiox is committed to fostering innovation, ensuring regulatory compliance, and supporting clients in achieving high standards of quality and safety. They are recognized for their deep expertise, global experience, and strategic partnerships, serving a diverse, international client base with practical, audit-ready solutions.
Industries
Nr. of Employees
small (1-50)
Services
End-to-end deployment, configuration, validation, and post-implementation support for enterprise electronic quality management systems tailored to life-sciences clients.
Comprehensive GxP internal and supplier audits, gap analyses, and pre-inspection readiness assessments with actionable remediation plans.
Gap assessments against ISO 13485 and other standards, and development of prioritized quality plans to achieve compliance.
Rapid development of CAPA plans and regulatory responses after inspections, including documentation suitable for submission to regulatory authorities.
Assessments and remediation planning for electronic recordkeeping, data security, audit trails, and compliance with Part 11 expectations.
Support for establishing process validation plans, test methods, and equipment qualification (IQ/OQ/PQ) to demonstrate consistent manufacturing performance.
End-to-end deployment, configuration, validation, and post-implementation support for enterprise electronic quality management systems tailored to life-sciences clients.
Comprehensive GxP internal and supplier audits, gap analyses, and pre-inspection readiness assessments with actionable remediation plans.
Gap assessments against ISO 13485 and other standards, and development of prioritized quality plans to achieve compliance.
Rapid development of CAPA plans and regulatory responses after inspections, including documentation suitable for submission to regulatory authorities.
Assessments and remediation planning for electronic recordkeeping, data security, audit trails, and compliance with Part 11 expectations.
Support for establishing process validation plans, test methods, and equipment qualification (IQ/OQ/PQ) to demonstrate consistent manufacturing performance.
Expertise Areas
- Regulatory compliance and remediation
- Quality Management System (QMS) implementation
- GxP auditing and inspection readiness
- Electronic Quality Management Systems (eQMS) deployment and validation
Key Technologies
- Electronic Quality Management Systems (eQMS)
- Computer System Validation (CSV)
- IQ/OQ/PQ equipment qualification protocols
- 21 CFR Part 11 controls and audit trails
News & Updates
A session hosted by Globiox during BioFest Days, guiding attendees through building a QMS in phases, emphasizing cost-effectiveness and strategic planning.
Recognition as a Premier Quality Assurance Firm at Biofest Invest
Globiox reaffirmed its commitment to innovation, growth, and collaboration within the life sciences ecosystem by sponsoring and participating in Biofest Invest.
High Frequency of CAPA-Related Observations in Warning Letters
Globiox monitors FDA inspection trends, noting a high frequency of observations related to Corrective and Preventive Actions (CAPA) deficiencies in Warning Letters.
A session hosted by Globiox during BioFest Days, guiding attendees through building a QMS in phases, emphasizing cost-effectiveness and strategic planning.
Recognition as a Premier Quality Assurance Firm at Biofest Invest
Globiox reaffirmed its commitment to innovation, growth, and collaboration within the life sciences ecosystem by sponsoring and participating in Biofest Invest.
High Frequency of CAPA-Related Observations in Warning Letters
Globiox monitors FDA inspection trends, noting a high frequency of observations related to Corrective and Preventive Actions (CAPA) deficiencies in Warning Letters.