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Vineti further demonstrates its ongoing commitment to enterprise-grade security, privacy, and compliance for its biopharmaceutical customers working in cell and gene therapies.
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Successful completion of SOC2 Type II audit comes as part of Vineti’s continuous expansion in the realm of compliance, with independent HIPAA re-certification also recently obtained and more than 18 remote audits and assessments successfully completed in the past 12 months.
Vineti, Inc., the provider of the leading digital platform of record for personalized therapeutics, today announced the successful completion of its Service Organization Control (SOC®) 2 Type II audit.
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The independent audit, conducted by a leading third-party SOC2 assessment provider, verifies that Vineti’s cloud-based Personalized Therapy Management® (PTM) Platform meets rigorous standards for data security, privacy, and trust. SOC2 compliance certification is recognized globally for its rigor in the review of the organization’s systems and organizational controls. SOC2 is an independent audit conducted to review the company’s effective implementation of employee controls and training, IT systems and risk management control, product discipline, and vendor selection. SOC2 Type II represents the most comprehensive form of SOC2 certification, as it represents a broad audit, not a point-in-time assessment.
“We are very proud of achieving SOC2 Type II compliance, a key stepping stone in our service maturity,” said Subbu Viswanathan, Vineti’s Compliance Officer and Senior Vice President of Quality, Security, and Compliance. “This reflects our ongoing commitment to all aspects of compliance for SaaS in healthcare and the life sciences.”
Vineti offers an independent, purpose-built enterprise solution that is essential for enabling the production and delivery of transformative personalized therapeutics, such as CAR-T cell therapies for the treatment of late-stage cancer. The PTM® Platform automates patient-centric supply chains for a wide range of cell and gene therapies, in all phases of clinical development and commercial operations.
This patient-centric, mission-critical support for personalized therapeutics requires an extra level of compliance rigor. The PTM® Platform supports multiple regulatory requirements and standards, including HIPAA, GDPR, GAMP5, Title 21 CFR Part 11, Annex 11 and NIST, and actively participates in industry forums such as the independent Standards Coordinating Body for Regenerative Medicine and Health-ISAC Inc. a global, non-profit organization focused on digital security in healthcare.
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In addition to SOC2 Type II compliance, Vineti recently completed a successful independent re-certification of security measures to safeguard Protected Health Information (PHI) and electronic Protected Health Information (ePHI) under HIPAA and HITECH. The company’s compliance approach has also continued to evolve amid the changing business environment brought by COVID-19, with more than 18 remote audits and external assessments completed successfully in the last 12 months. With more than 20 biopharmaceutical customers over the course of the company’s history, and the number of customers in production on PTM® quadrupling in the last year, Vineti continues to evolve to meet the needs of the CGT ecosystem, even in an era of remote work and collaboration.
“Our team’s focus and diligence have made sure that Vineti’s security and compliance keep pace with our evolving industry and fast-changing business environment,” said Amy DuRoss, CEO and Co-founder at Vineti. “As our SOC2 compliance demonstrates, we are always working to meet the high security and privacy standards required to support our biopharmaceutical customers and the patients they serve.”
This news follows more recent growth at Vineti, including the release of the company’s new PTM® Integration Suite to provide purpose-built, patient-centric interoperability for cell and gene therapies.
