Certifications & Compliance

Certifications & Compliance | Data Security

GlobalVision offers products that are designed, built and released under the most rigorous quality control process. We continuously undergo rigorous external audits to ensure that we meet the highest quality standards. Our ISO certification is a testament to our dedication to our customers and the quality in which we design and develop our systems.

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.

View certification

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FDA 21 CFR Part 11 Compliant

GlobalVision has all of the Technical Controls for 21 CFR Part 11 compliance built into our products.

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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.

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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.

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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.

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GlobalVision’s Commitment to Compliance

  • ISO 9001-2015 Certification

  • Software Development Lifecycle

  • – FRS
    – DDS
    – 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

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