It's time to embrace faster development timelines, reduced costs per treatment, and ultimately, let more patients gain access to your groundbreaking therapies.
Achieve Efficient, Scalable Production
Standardize and Streamline Data
Take the guesswork out of your paperwork by embracing standardization and streamlining data entry via barcoding, automated calculations, and enhanced systems and device integrations.
Electronic Batch Records (EBR)
Build a more engaged workforce with intuitive, easy-to-follow electronic Batch Process Records (eBPR) designed to automate repetitive tasks and streamline your documentation burden.
Optimize Logisitics
Break down data silos and gain complete visibility into your entire process to streamline patient sample collection, transportation, manufacturing, and product delivery.
Faster Approvals
Speed up your batch record review and approval process with instant access to your data, on-screen 21 CFR Part 11 compliant electronic signatures for sign offs, supervisor reviews, secondary routings, checkpoints, and fail safes that are all designed to conform to your standards and embrace your nuances.
Regulatory and Accreditation Compliance
Document bi-directional traceability of equipment, supplies, products and personnel, easily generate barcoded products labels including ISBT 128 templates, automate full chain of custody tracking, and maintain batch records and product release in line with the ever-changing regulatory and accreditation frameworks.
Unlock Real-Time Data Insights
Automated Alerts
Keep your team focused on what they need to do not what they don’t through built-in alerts and reminders.
Supply Chain Management
Ensure a reliable supply chain that maximizes your operational capacity by minimizing stockouts and overstocking, and streamlining production planning.
Cost Controls
Control costs through real-time data visibility at every stage of production.
Interactive Dashboards
Leverage real-time interactive dashboards designed to monitor your Key Quality Indicators (KQIs) and Key Performance Indicators (KPIs).
Custom Reports
Easily perform ad-hoc queries to gain more insight into your program and your products.
Data Entry & Interface Matters
A 2019 study of manually entered point-of-care lab test results showed that 73% of lab data pairs had a discrepancy.
The amount of clinical data containing errors resulted in a deviation from the appropriate care for the patient.
Mays, J. A., & Mathias, P. C. (2019). Measuring the rate of manual transcription error in outpatient point-of-care testing. Journal of the American Medical Informatics Association, 26(3), 269–272. https://doi.org/10.1093/jamia/ocy170
Included Modules
Batch Record
Easily document a growing number of patients, protocols, and products including support for HCT, HPC, BM, MNC, CAR-T, IEC, and Third Party Sponsors.
Collections & Apheresis
Capture all essential donor information including eligibility, consent, and health history for all your allogeneic and autologous collections.
ISBT-128 Labeling
Automatically generate various sizes and formats of the latest ICCBBA-specified ISBT 128 product labels at every stage of processing with a click of a button.
Product Inventory & Storage
Document full lot-to-lot traceability and chain of custody for all your products so you know what you have, when, and where.
Product Order
Specify your unique product targets and processing requests for each treatment order directly within Title21 or automatically from your existing EMR/EHR workflow.
Product Release
Automate your product release checklist and related sign-off stages to release final product(s) for infusion within Title21 or your LIS.
Consumables Management
Easily document and track usage of every consumable, supply, reagent and manufactured consumable (including kits) to streamline traceability, identify real-time inventory, and avoid production delays.
Electronic Routing & Approvals
Automated workflows that ensure your forms are completed, reviewed, and routed appropriately and accurately across your team.
Regulatory & Accreditation Management
All the tools you need to support the ever-changing requirements for accreditation including FACT/JACIE, AABB, ISBT 128, GxP, HIPAA, 21 CFR Part 11 electronic signatures and more.
Free White Paper
Interoperability Unlocks the Potential of Digitalization
Lack of interoperability in healthcare creates communication silos, increasing errors and delaying treatment, ultimately harming patient outcomes. The future depends on seamless information sharing and patient-centric care. Download our free white paper to learn how interoperability can transform healthcare.
Complete the form to download.
Ready to Focus More on Patients and Less on Paperwork?
Learn more on how Title21's industry leading cellular therapy software solutions can help you save more lives.