Cell Therapy Supply Chain Compliance and Quality

Advanced therapy supply chain compliance software

Quality and compliance are foundational to every aspect of cell and gene therapy delivery, underlying all operational and production processes. Patient-specific therapeutics require rock-solid Chain of Identity and Chain of Custody to deliver high quality, compliant, advanced therapies to the right patient, every time. There is no room for error in personalized medicine: quality and compliance must be perfect to avoid potentially catastrophic mistakes.

Vineti’s PTM® platform, the only independent digital supply chain solution of its kind to support commercially-approved therapies in the U.S. and EU, provides permanent and transparent association of a therapy to the complete record of all activities involved from end to end. PTM® also delivers industry-leading security, reporting, and centralized compliance and control.

Woman looking at computer

Challenges and solutions

Quality and Compliance teams hold the key to providing efficacious advanced therapies that are also safe and meet regulatory requirements. However, cell and gene therapies are some of the most complex to produce, which presents several obstacles to the  rigorous quality procedures and precise compliance required.

Vineti’s Personalized Therapy Management (PTM)® platform has already orchestrated thousands of patient and product journeys worldwide. PTM® allows you to manage compliance and quality while keeping every product journey on time and on track.

  1. Chain of Identity, Chain of Custody, and Chain of Condition must be tracked and captured, and are extremely difficult to manage using manual or legacy systems.

    Solution: Automated Chain of Identity, Chain of Custody, and Chain of Condition

  2. Multiple, complex regulations (HIPAA, GMP, GAMP5, 21 CFR Part 11, EUDRALEX Annex 11, GDPR, NIST) must be met in an ongoing fashion for every patient product, at volumes, and in combinations never seen before in the life sciences. Data systems must be kept secure.

    Solution: Built-in conformance with regulations and standards: HIPAA, GMP, GAMP5, 21 CFR Part 11, EUDRALEX Annex 11, GDPR, NIST

  3. Dozens — or even hundreds — of stakeholder hand-offs may occur for every batch, and each must be tracked and captured. Amid these hand-offs, the high quality of the starting material and finished product must be maintained.

    Solution: Efficient, documents, trackable stakeholder handoffs — with notifications when deviations occur

  4. Auditors, inspectors, and regulators expect to see large volumes of data for each batch in ways that are readily available, high quality, and actionable. Reporting requirements are rigorous.

    Solution: On-demand reporting to support investigations and inspections, with custom reporting options

  5. Creating or changing seemingly simple documents or SOPs can steal valuable time from processing patient orders.

    Solution: A flexible label printing solution that supports ISBT-128 and SEC standards, and also supports change management, label reconciliation, and version control

  6. In-process labels are essential to compliance and COI, and need to be flexible to respond to the frequent changes seen in most cell therapy product journeys.

    Solution: Label, COI/COC, order, and DP tracking in real-time

  7. Centralized control and compliance can be very difficult to maintain across a distributed ecosystem.

    Solution: Network-wide compliance from a central administration point (SOP/WI changes, label templates, site and user qualification, and more)

  8. Many stakeholders participate in Quality and Compliance processes — but access to relevant data and workflow systems must be tightly controlled.

    Solution: Admin/MDM tools to set up, manage, and control access to your company’s instance of the Vineti system

The main concern is the handoffs. The process has so many handoffs from one stakeholder to the next. That creates an immediate need focused on a COC/COI solution. You need to time this with a low number of patient schedules — even that early phase can add up if there are four to five treatments a month. Begin with the idea that you will be able to scale it ‘up AND out’.

Quality and IT executive, advanced therapy regulatory advisory firm

Mastering Quality and Compliance with PTM®

If you focus on Manufacturing Quality, PTM® delivers the transparency and traceability you need with:

  • Automated, industry-leading Chain of Identity and Chain of Custody.
  • Automated, on-demand, real-time reporting, including COI and COC.
  • Cloud-based label review, reconciliations assistance, and change management.
  • Centralized, cloud-based administration of processes, procedures, and label templates.
  • Workflows that support GMP compliant procedures; e-signatures that are 21CFR Part 11 and EUDRALEX Annex 11 compliant.
  • Digital tracking and recording of patient data, key milestones, and decision criteria to support batch record review.
Healthcare worker reviewing information on her tablet

If you focus on protecting your systems and data, PTM® delivers state-of-the-art security with:

  • Best-in-class physical, network, application, and data-level security to protect all product, process, and stakeholder data.
  • Rigorous regulatory requirements and standards already built into the platform, across multiple countries and regions.
  • GAMP5 platform validation, adhering to standards and practices in specification creation, verification, and testing processes.
  • Focus on data privacy and data integrity including ePHI
  • Robust information and application security program providing security and privacy by design
  • State of the art tools and experienced security engineers ensure your data – and patients – are safe
Healthcare worker reviewing information on her tablet

Compliance and Quality are foundational for CGT

Get a glimpse! Vineti’s Personalized Therapy Management (PTM) platform is the essential solution for speed, safety, and scale. Quality and compliance are foundational to every aspect of cell and gene therapy delivery and Vineti provides automated Chain of Identity, Chain of Custody, and Chain of Condition tracking. Compliance users can easily download relevant, human-readable reports such as the Chain of Custody or Systems Transaction Reports and within the workflows themselves, we can configure a quality release step, which ensures final products are approved for release before being shipped to the treatment site. Get in touch with us today to learn more!

Demo video

See PTM®’s personalized supply chain management solution in action in this short video

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Whether you manage Quality and Compliance for five patient products or 5,000, Vineti is here to help.

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