Software configuration, implementation, and ongoing support
Establishing a personalized therapy supply chain is complex. In addition to providing a dynamic, flexible SaaS solution, the Vineti Service Team is here to simplify the process of setting up and running each therapeutic workflow. From initial engagement through ongoing support and upgrades, Vineti provides supportive, detailed, always-on, exceptional service.
Not sure where to start? Vineti's experts can help.
Vineti works as a strategic and functional partner with customer stakeholder teams to simplified implementation.
The success of how Vineti drives the therapeutic workflow depends on how specifically the workflow was mapped prior to configuration. With our expertise in setting up and scaling many personalized therapeutics, the Vineti team can perform a supply chain process review. They can collaborate on optimizing the workflow for your therapy, whether the treatment is in early-stage clinical trials, late-stage, or scaling commercially.
If needed, the Vineti Customer Success team can assist with the requirements gathering phase. Agreeing upon the User Requirements Specification (URS) is a key first step. Customer Success will begin with advising on the best validation pack to meet requirements of regulatory bodies; this is a critical outcome that drives many decisions throughout the implementation process.
To support the therapeutic and business targets of each customer, the Vineti Implementation Team drives the software configuration and integration implementation to spec on time and within budget.
As a SaaS solution, the Vineti Implementation Team works to align the flexible platform to meet therapy workflow and product needs as quickly and easily as possible.
Vineti's workflow engine offers proven connectivity with other systems and technologies in the therapeutic ecosystem. Our Implementation Team works with you to create connectivity with other data and processing solutions such as EBR, ERP, IWRS, MES, CRM, and logistics systems.
Many of these complex therapies require some additional solutions to fully support the specific end-to-end steps for that particular process. If needed, the Implementation Team can drive the delivery of customized solutions.
Compliance and Security
The Vineti Compliance Team works with the customers' IT and Quality organizations to generate a robust risk-based validation and testing package to adhere to all applicable requirements.
Biopharmaceutical companies are getting an industry-specific compliant solution with every implementation. Running on Amazon Web Services (AWS), Vineti is compliant with critical standards for needed cell and gene therapies, specifically:
Title 21 CFR Part 11
PRODUCT SPECIFIC DOCUMENTATION
Product specification documentation ensures that all parties are in agreement on the details of what will be delivered, how it will be tested, and what will be flexible for scale.
VALIDATION AND TESTING
The Compliance Team makes certain that the solution is fully validated at launch, as well as validated for ongoing compliance in an adaptable environment.
The success of the Vineti Personalized Therapy Management software deployment depends on the expertise of those responsible for using, maintaining, and administering the solution.
With the Vineti Training Service, customers receive in-depth, hands-on, module-by-module instruction to continue training others at scale. Vineti training accompanies each implementation and is tailored to each therapy's specific workflow. Training always includes:
Custom Training Manuals
Training Trainers Sessions
The dedicated Vineti Customer Support team is available to customers 24/7/365...globally. Customer Support provides customized technical and operational support based on Service Level Agreement to ensure that each implementation continuously meets the day-to-day needs of the therapeutic ecosystem.
ALWAYS ON HELP
With our compliant solution, Vineti's infrastructure automatically runs Continuous Monitoring. With global representation, Vineti Customer Support is always "on-call" to address any immediate concerns that may arise, including enacting Disaster Recovery protocols.
Vineti's Account Managers are available to help navigate the long-term product lifecycle required to scale, and are available to collaborate on additional product feature needs for implementation as each therapy scales.
One of the primary benefits of cloud-based solutions is dynamic lifecycle management.