Security and Compliance

Vineti is a cell and gene therapy orchestration platform designed specifically to address the regulatory challenges (GAMP 5, 21 CFR Part 11, HIPAA, GDPR, Annex 11) faced by the cell and gene therapy industry, including biologics manufacturers, contract manufacturers, couriers, and other stakeholders.

Our demonstrated track record and commitment to data security, data integrity, validation, electronic signatures, and audit trails have made Vineti the standard-setting cell and gene therapy orchestration platform.

Vineti is committed to enabling and supporting the design and manufacture of safe and effective personalized therapies and ensuring the confidentiality, privacy, integrity, and availability of all electronic protected health information (ePHI) it receives, maintains, processes and/or transmits on behalf of its customers.

We do so by the design and development of secure, compliant software while fostering an environment of continual improvement. We proactively address information security and mitigate risk for our customers. We are committed to maintaining an effective compliance management system that complies with all regulatory and customer requirements.

Vineti’s Compliance Approach

To achieve these goals, Vineti operates a compliance management system, with common elements and processes, which comply with internal policies as well as with national and international standards (e.g. ISO) and regulations (e.g. GAMP5, NIST). The fundamental elements of these systems are continuously undergoing improvements alongside industry-wide compliance updates.

Vineti’s process-oriented compliance management system consists of management instruments which define the structure, organization, responsibilities, processes, and methods for the implementation of the company’s compliance policy.

Vineti’s compliance management system is a management tool for the

  • Description and mastering of the essential business processes
  • Assignment of responsibilities for tasks and decisions
  • Identification of key success factors and measurement of performance
  • Definition and management of important inputs and outputs
  • Periodical auditing of the processes and assessment of the system

Vineti’s compliance systems comply with the internal compliance policy and follow the compliance system models set forth in ICH Q10, ISO 13485, and ISO 27001.

As an enterprise software developer for the life science industry, Vineti is fully committed to compliance with the GAMP 5 Computerized System Validation methodology, Health Insurance Portability and Accountability Act (HIPAA), and the European Union’s General Data Protection Regulation (GDPR, in process for mid-2018), as well as implementation of relevant NIST cybersecurity guidelines.

Security

Data security is paramount for Vineti and our customers. Vineti maintains a comprehensive security program based on ISO 27001 to ensure the confidentiality, integrity, and availability of customer data.

Vineti leverages the most advanced cloud infrastructure to provide an innovative, scalable, global, predictable, and secure environment.

Given the sensitive nature of security systems and procedures, please contact us for further details of Vineti’s privacy and security approaches.