ViQi’s Compliance Commitment in Drug Development

A Partnership for GxP Readiness

 

At ViQi, we are on a steadfast journey toward GxP compliance, ensuring our platform and products meet the rigorous standards set by Good Practice (GxP) regulations. GxP regulations are pivotal guidelines governing the manufacturing, testing, and distribution of pharmaceuticals and medical devices. The ViQi Data System (VQDS) is registered with the FDA as a Class 1 non-device Medical Data Device System (MDDS). Below are some examples of steps necessary to comply with the MDDS standard.

Specific Examples of Our Progress

  • Development of a Comprehensive eQMS: Documenting and implementing all necessary processes and procedures for ensuring quality and compliance in our eQMS system.

  • Conducting Rigorous Risk Assessments: Identifying and mitigating potential risks to platform and product quality and compliance.

    • Services hosted on AWS, fortified with multiple layers and firewalls

    • Robust policies and SOPs addressing business continuity, disaster recovery, and contingency planning

  • Validation of Platform and Products: Ensuring that the system meets intended specifications and standards through design control.

  • Establishment and Maintenance of Data Integrity: Ensuring accuracy, completeness, and reliability of all data utilized by our platform and products.

  • System & Data Security: In our informational systems and operational procedures, we adhere to the following.

    • Compliance with legal requirements for handling personally identifiable data

    • Encryption of data in flight and at rest

    • Active monitoring and alert management by our platform team

    • Regulation of data access through role-based access control

    • Implementation of a data protection & privacy policy with mandatory annual training for all employees

    • Yearly internal audits of our cybersecurity policies and participation in Vendor Audits by our clients and partners

 

We are in the process of obtaining our ISO 9001 and ISO 27001 (information security) certifications. We are also working with a partner currently completing a 510k submission with ViQi as a supplier. Our commitment remains resolute towards achieving GxP compliance to offer the highest quality products and services to our valued customers.

We are actively seeking partners to ensure that our assay systems are part of their GxP certification. For further inquiries or clarification regarding our compliance efforts, please contact us at regulatory@viqiai.com.