Certifications & Compliance
GlobalVision’s goal is to create the best digital inspection software that saves time and brings confidence to quality control. We strive to build products of the utmost quality while delivering best-in-class customer service. Our goal is that every interaction reflects the highest level of customer satisfaction, and to exceed customer expectations.
The quality of our products is determined by the satisfaction of our customers and the performance of our systems. We are committed to the continuous improvement of our organization, systems, and processes in order to build world-class products for our customers, and continue to innovate in our industry.
GlobalVision is ISO 9001:2015 Certified
ISO is implemented and maintained at all levels of the company to provide customers, as well as GlobalVision assurance that:
- Designed and integrated products conform to specified requirements.
- Nonconformities are detected and controlled rapidly.
- Corrective and preventive measures are taken to avoid the re-occurrence of the nonconformities.
FDA 21 CFR Part 11 Compliant
GlobalVision has all of the Technical Controls for 21 CFR Part 11 compliance built into our products.
Annex 11 Compliant
GlobalVision has all of the Technical Controls for Annex 11 compliance built into our products. Annex 11 is the European equivalent to 21 CFR Part 11 and is required if the product is intended to be sold in the EU.
CGMP (Current Good Manufacturing Practices) Compliant
Current Good Manufacturing Practices are practices required in regulated industries to ensure that products are consistently produced and controlled according to quality standards and designed to minimize the risks involved. GlobalVision systems demonstrate a strong commitment to following these regulatory standards.
GAMP 5 (Good Automated Manufacturing Process) Compliant
GlobalVision is compliant with regard to GAMP 5 guidelines, designing systems that meet regulatory requirements and are fit for use in the pharmaceutical industry, as prescribed by the International Society for Pharmaceutical Engineering.
GlobalVision’s Commitment to Compliance
- ISO 9001-2015 Certification
- Software Development Lifecycle
- Unit Testing
- System Testing
- Hardware Testing
- Validation Document (IQ, OQ, PQ)
- Complete Validation Services
- cGMP Compliant
- 21 CFR Part 11 Compliant
- Annex 11 Compliant
GlobalVision is confident that its systems address data integrity issues and can be counted on by all GXP regulated companies.
The following is in place at GlobalVision:
- Quality Management System with SOPs and logical controls to ensure clear accountability
- Controls to ensure physical/logical security, change management, service management and system continuity
- Vendor management qualification program
- Backup/recovery procedures executed
- Internal Audits conducted
- All systems follow a Software Development Lifecycle approach
- All systems are validated
- All systems contain audit trails demonstrating data ownership to ensure no deletion or modification of records
- All systems ensure records are secure with limited system access
- All employees are properly trained; training records are documented and maintained
GlobalVision is committed to the protection and integrity of information to ensure that data remains confidential for our employees, third parties, and users. Appropriate systems are used to protect against theft, abuse and other forms of harm and loss and to maintain the 24/7/365 access of services. We strive to ensure the availability and reliability of our network infrastructure and the services supplied and operated by us.
SoftLayer (GlobalVision‘s hosting provider) is SSAE 16 certified
GlobalVision runs on servers provided by SoftLayer technologies to deliver our service. SSAE 16 (Statement on Standards for Attestation Engagements) has replaced the Statement on Auditing Standards No. 70 (SAS 70) as the primary standard for reporting on controls at service organizations. It is an attestation standard issued by the American Institute of Certified Public Accountants (AICPA). Specifically, SSAE 16 addresses engagements conducted by service auditors on service organizations for purposes of reporting on the design of controls and their operating effectiveness. See Softlayer certifications.
Access to all GlobalVision servers is secure
Firewalls (IPTables) on all servers are set to default-deny. The only services that are allowed are SSH (all servers; non-standard port) and HTTP/HTTPS (web servers only). No other organization ‘s servers reside on the GlobalVision subnets at Softlayer. All communication with servers (outside of public HTTP/HTTPS access) is over encrypted secure shell (SSH) and password authentication is disabled.
GlobalVision data is protected
Specific measures include:
- SOC 2 certification assures SoftLayer customers that the company has effective operational Hosting Services
- All servers are located behind the firewall with only essential ports enabled
- All firewalls have Intrusion Detection enabled
- All Licensee data is stored in separate physical databases
- 256-bit SSL encryption