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Cell & Gene Therapy Manufacturing

Cell & Gene Therapy Manufacturing

Deliver Safe and Effective Personalized Therapies with Real-Time Traceability

  • Gain production visibility

    Track KPIs and monitor your operations from any device to make informed decisions

  • Define your own metrics

    Customize data collection for unique solutions with flexible data structures

  • Integrate equipment and software

    Consolidate data, monitor machines, and leverage bidirectional software communication

  • Hands-free devices

    Augment operators and reduce mistakes with wearable technology and foot pedal connectivity

  • Complex supply chain requires bidirectional traceability

    Tracking a product’s chain of custody and chain of identity is challenging as the product moves through facilities, processes, and people. Tulip’s electronic batch records are a customizable solution to automatically capture data, generate a product’s genealogy and ease documentation to ensure your product is safe, high-quality, and compliant.

  • Simplify quality management

    Cell and gene therapies are at risk of poor collection quality, improperly handled products, and product/patient mix-ups. Define and leverage quality management tools that fit your processes to identify and mitigate risks and improve quality throughout your operations.

  • Interface with all of your systems from one place

    Collection centers, labs, and distribution centers utilize their own software to track information, making it difficult to have a comprehensive view of your operations. Tulip connectors and integrations enable bidirectional communication between software systems to increase data accessibility, visibility, and usage where you need it.

electronic batch record - eBR - digital work instruction - life sciences

Streamline compliance with right-the-first-time eBR and eLogbooks

Human-centric apps automate data capture and guide operators through workflows to ensure every step is completed thoroughly and documented correctly. Ensure every document and table has FDA 21 CFR Part 11 and Annex 11 compliant electronic signatures. Easily generate thorough reports for reviews, audits, and inspections.

Gain a holistic view of operations

Advanced therapy manufacturing generates data at high volumes, variety, and velocity from a multitude of systems. By capturing this data, you can reveal trends across your operations that can inform decision-making. With Tulip, you can deploy a scalable, customizable, and readily integrated eBR solution to make data management more efficient.

Batch History Review - Quality Management
  • Scalable

    Manage multiple sites as individual workspaces that can share best practices and establish separate governance structures

  • Customizable

    Track the data points you need with Tulip’s flexible data structures

  • Readily Integrated

    Tulip seamlessly connects with ERPs, LIMS, QMS and other systems

TEC Demo - Life Sciences - Realwear Wearables

Operate hands-free to increase productivity and reduce error with wearable devices

Tulip apps on wearables are easy to implement in GxP regulated operations. Configure dynamic workflows that guide operators and provide the information they need when they need it. All operators can view dashboards with real-time data and conduct hands-free data collection with only their voice.

LS Dashboard - Weigh and Dispense - Batch Processing

Empower your decisions with real-time data

Monitor dashboards from any device to inform you on supply chain disruptions, progress towards goals, and staffing shortages. Customize dashboards to display any chart or KPI to provide the contextual data required to lead a company.

Deploy powerful custom apps with confidence

Focus on value-adding work by building apps specific for each intended use. Tulip provides validation artifacts for the platform, enabling a focused, risk based validation approach to help organizations deploy solutions rapidly.

Electronic Batch Records application running in Tulip
  • Delivered qualified

    Reduce the burden of validation with Tulip’s platform qualification artifacts provided with each software release

  • Build and Validate

    Simplify compliance by defining risk control strategies as part of building apps, then just execute to show validation for intended use

  • Continuous Validation

    Demonstrate control of your processes by reviewing data from app executions to verify control strategies are in place

Digital History Record

Gain end-to-end traceability

Get immediate value from Tulip by accessing over 140+ applications in the Tulip Library. Use our apps to collect data quickly and accurately, manage CAPAs, and use our ready-made connectors to accelerate value in your frontline operations.

ArchForm Aligner Line

ArchForm gains forward and backward genealogy with electronic batch records.

Tulip’s flexible digital history records gave ArchForm, a custom dental aligner manufacturer, complete traceability as their product transforms from a batch print, to a custom product, to part of an assembly kit. This flexibility eased the burden of compliance, allowed them to scale their operations, and double their production capacity.

Digitally transform your operations with Tulip

See how systems of apps enable agile and connected operations.

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