GlobalVision is committed to the protection and integrity of information to ensure that data remains protected for our users, employees, and third parties. With validated systems, comprehensive internal audits, and multiple verifications during the development and delivery stage, we address data integrity issues and can be counted on by all GXP regulated companies.
Compliance & Certifications
> GlobalVision is ISO 9001:2015 Certified
ISO is implemented and maintained at all levels of the company to ensure that:
- Designed and integrated products conform to specified requirements
- Nonconformities are rapidly detected and controlled
- Corrective and preventive measures are taken to avoid the recurrence of non-conformities
> FDA 21 CFR Part 11 Compliant
All Technical Controls for 21 CFR Part 11 Compliance are built into GlobalVision’s products.
- Audit trail
- Electronic signatures
- Login management
- User access controls
- Admin controls
> Annex 11 Compliant
Required for use in the EU, GlobalVision has all Technical Controls for Annex 11 compliance built into our products.
> CGMP (Current Good Manufacturing Practices) Compliant
Current Good Manufacturing Practices ensure that products are consistently designed, produced, and controlled according to quality standards. GlobalVision is strongly committed to following these standards and practices to ensure that our systems are built for use in regulated industries.
> GAMP 5 (Good Automated Manufacturing Process) Compliant
GlobalVision is compliant with GAMP 5 guidelines by building systems that meet regulatory requirements and are fit for use in the pharmaceutical industry.
Security Policies & Software
> Software Development Lifecycle
All GlobalVision systems follow a Software Development Lifecycle approach to ensure the design, development, and testing of the highest quality software:
- Unit Testing
- System Testing
- Hardware Testing
> IQ, OQ, PQ Validation Documentation
GlobalVision offers complete validation services to ensure all systems are fully validated for use in regulated industries.
> Quality Management System
GlobalVision has SOPs and logical controls in place to establish and maintain clear accountability. These controls ensure physical and logical security, change management, and system continuity. The following procedures are also in place at GlobalVision:
- Vendor management qualification program
- A disaster recovery plan that is tested and reviewed yearly.
> Audits & Records
Internal audits are regularly conducted at GlobalVision. All systems contain audit trails that demonstrate data ownership and ensure that records have not been deleted or modified.All systems protect records by ensuring they are secure with limited system access.
All GlobalVision employees are properly trained, with training records documented and maintained.
GlobalVision data is primarily hosted in North America. This data is hosted in fully certified SOCII data centers.
GlobalVision values the importance of the systems we deliver to our clients. Systems availability and uptimes can be seen on status.globalvision.co