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.
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.
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.
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
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!