Title21 Software Offers Solutions & Services Designed for You

Title21 Software offers a user-centric solution that is configured and integrated to become your solution. All modules are integrated to help minimize the risk of non-compliance and to allow you to realize the benefits of an agile workflow management system.

Title21 Software offers a plethora of solutions for your lab, hospital or center from Error Management to Audits and even Clinical Data Management. No matter what solution that you utilize, you can be confident that with Title21 Software your solutions are integrated. In other words, the modules and products are integrated to minimize any compliance gaps and to avoid double data entry. All Title21 products are designed to work together to provide maximum functionality, sharing of data, triggers, alerts, combined analyses and reporting for optimum end -to-end decision making   

For workflows to be effective, they must be integrated throughout your organization. Business processes perform best when communication and tasks are coordinated. For example, when mandatory training is a prerequisite to perform a particular task, a well-integrated system can ensure this training is completed prior to permitting performance of that task. And that’s why the basis of the Title 21 Software platform is its native integration capabilities. Native integration means Title21 Software modules were designed from the ground up to communicate and work with each other, while at the same time, not hindering the ability to configure the system your way. This capability serves to prevent items from ‘falling through the cracks’, eliminate double-data entry, and close the gaps in your individual processes to create an overall quality system.

Other software products may integrate, yet limit your configurability options. While still others provide some level of configurability, but force you to compromise on native integration by asking you to buy other third party products in their attempt to deliver a “complete solution”. Only a system built on a foundation of integration and configurability can deliver on this promise.

Best Warranty in the Industry

Title21 Software offers the best warranty in the industry with a One Year Customer Delight Guarantee from the time of purchase. The Title21 Software warranty is over ten times the length of other software vendor warranties. Most other warranties expire before their system is deployed and live in your environment. Title21 Software is committed to delighting partners, and we stand by that promise. We partner with our customers long-term by  delivering a powerful, dynamic, fully-configurable and integrated solution that consistently exceeds customer expectations.

Title21 Software launches Version 6.0 with Increased Power and Capabilities     

Title21 Software Version 6.0 delivers the platform as an even easier-to-use system. Training Wizard walks trainees through their assigned training without any previous system training. 

Administrator and User configurable dashboards that deliver only what users need and right to their desktop. All tasks can be completed directly from the personal dashboard with fewer clicks.

The New Rapid Review capability supports a more efficient approach to periodic reviews and saves the Medical Director’s time.

Easy and Efficient Periodic Reviews help support AABB and CLIA requirements.

Inventory Control Module helps you manage supplies and products through receiving, inspection, processing, storage and distribution with full Lot Control traceability.

T21 Cloud Solution

No IT Infrastructure or Support Needed. All you need is a Web Browser.

Title21 Software introduces T21 Cloud where the user logs onto any PC and the T21 solution and data are accessible through any web browser. As the pace of business speeds up, the regulations change and customers become more demanding, you need to leverage the benefits of technology to become better, cheaper, faster in today’s competitive environment.

Now with T21 Cloud, companies’ internal I.T. departments do not need to get involved in the deployment or the maintenance of Title21 Solutions.  This allows you to go live with the system in a shorter period of time rather than waiting for your project to reach the top of I.T.’s priorities. T21 Cloud now provides you with a more powerful solution, a faster deployment and no IT support required. Your company will benefit by increasing the agility and elasticity of your business.

With this virtualization approach, you have the computing power, memory, storage, and network bandwidth that you need at any given time. T21 Cloud makes these requirements achievable on a real time basis. The application and the data are shelled out from a private multi-tenant pool of hardware and software resources. You can also rest assured that T21 Cloud delivers the highest level of security as a Private Cloud.

Title21’s Integrated Go-To Solution offers a wide variety of applications on a powerful platform, so you can easily leverage your investment and minimize the need to maintain outdated, legacy software and hardware. T21 can add exponential value to your business and can deliver a very fast and healthy ROI. Title21’s virtualization will free up IT departments to add more value to your business.

With T21 Cloud, there is no longer a need for repetitive capital investment to replace hardware and software every three to five years is eliminated as well as the high operating costs. Instead, technology can be deployed to reflect the current business needs, so companies can pay as you go and grow.

T21 Cloud Provides T21 SaaS - Our Software as a Service offers a way of providing the same software to different customers via a network, usually the Internet. Title21 Software is hosted on the T21 Cloud and not individual computers, so there is no IT support required. Title21 offers high availability service and is responsible for system configuration, updating, and maintenance of the software and hardware. T21 Cloud offers you a very powerful, integrated solution that can be configured to meet your specific requirements and that you can access from your home, office  or anywhere via a web browser. You no longer have to give up functionality and change how you conduct your business to have accessibility through the Internet.

Introducing T21 CT Solution!  The Most Powerful Solution in Cell Therapy

Title21 Software brings its biologic industry expertise to Cellular Therapy.  Now CT labs can capitalize on the powerful and integrated platform engine that allowed blood centers, pharmaceuticals and medical device firms to reduce costs, improve quality and increase productivity.

T21 CT Solution manages many of the labs most critical processes like data management, inventory control, documents & SOPs, equipment and maintenance, training and virtually any other process. The CT laboratory community asked for it and Title21 delivered! Sign up for a demo or a webinar of T21’s CT Solution and learn what is possible now in Cell Therapy.

Document Control Solution

Manages all your revision-controlled documents by automating the creation, collaboration, and routing of documents. You can track documents, assign tasks, define signature routings and set automatic e-mail alerts. All of your existing revision-controlled electronic documents will be imported into Quality Manager, so you can have one central repository for all your documents.

Process Improvement Solution automates any workflow. With our forms-based BPM solution, your quality data management and all other processes can be managed from a single interface to automatically track, trend, alert and report.

Any processes can be automated with Title21 Solutions.Title21 Software has many processes available as out-of-the-box templates that can be modified to meet your specific needs. Title21 Software also can easily configure any process according to your form and SOP requirements.

Title21 offers a wide range of products that are designed to be implemented efficiently and effectively.        

Error Management

Centralize and optimize your error management system. No more “lost” error reports.

Occurrence and Near Miss Reporting

Track “Near Miss” events and take action before they become significant problems.

Hemavigilance

Implement Hemavigilance from donor to recipient with the codes built into the system and hyperlinks built in as well.

Corrective Action/CAPA

Eliminate issues by addressing their root cause. Manage multiple CAPAs with less resources and greater effectiveness. Manage CAPA through plan development, Implementation, Effectiveness checks to closure.

Complaint Handling

Handle complaints from customers and ensure follow-up is timely.

Donor Incidents/Reactions/Post Donor Information

Find and correct adverse trends from the donor to improve your donor experience.

PTO Process

Manage your PTO process with less effort and less manpower than ever before.

Non-Conformance

Document Non-Conformances efficiently and track resolutions.

Risk Management

Assess events and occurrences with Risk Management tools to help detect signals from the noise.

Receiving, In-Process, Finished Product Inspection/Test

Manage supplies, components, assemblies and products from receiving through manufacture and distribution.

Deviations

Implement Deviation Management with minimal resources and ensure processes and procedures subject to deviations are controlled efficiently and effectively.

Adverse Event Reporting

Document and report on adverse events in a timely manner.

Look back/Recall Process

Facilitate the look back and recall process with quick and easy documentation, notification and follow-up reminders.

Reagent Quality Control

Control the quality of your reagents with easy to use and configurable forms that support out-of-tolerance validation and automatic email notifications for non-conforming supplies.

Supplies Management

Manages receipt, inspection and test, storage, distribution and reordering of supplies and products.

Equipment Maintenance/Calibration

Document Equipment maintenance and calibration with reminders of upcoming activities.

Facilities Management/Maintenance

Manage facility process and facilities equipment.

Audits

Perform internal and supplier audits with greater traceability and follow-up.

MSDS Maintenance

Maintain all your facilities MSDS with more control.

Change Control

Bring Change Control to your organization with flexible and easy to implement workflows that provide a solid foundation for organizational control.

Batch Records

Records Batch Records using forms and workflows virtually identical to your current paper-based system, thereby reducing the learning curve significantly.

Customer Relationship Management

Manage your customer or patient contact with Title21 Solutions for improved communication with your customers.

Requirements Management

Define, document and manage requirements and any requirement changes for any project that your firm is managing. From software deployments to new product introductions, Title21 can effectively document and manage the requirements development and approvals for any project, both internal and external.

Training and Learning Management Solution handles all your training needs to reduce human errors and potential non-compliance issues. The T21 Training Wizard makes executing training tasks very simple and easy, so that the trainee does not require much training on the system to perform the tasks. Training can be delivered anywhere to anyone. Alerts and reminders can automatically be sent to notify personnel of monthly, quarterly, or annual training requirements.

The Training solution includes:

• Read-and-Sign training
• Course assignments
• On-line exams
• Randomized test questions
• Mandatory Correct Exam Questions
• Automatic correcting and grading
• Automatic exam reissue on failure
• Exam assignments based on job functions
• Automatic alerts for past due certifications
• Use your existing training videos and other multimedia for training
• Individualized training plans
• Automatic training and certification reporting
• Competency records, certifications and credentials
• Training Lock-outs

Clinical Data Management Solution offers small to mid-sized community based hospitals and labs a means to adopt a dynamic solution to help manage clinical trials without the need for a million dollar budget. With T21’s Clinical Data Solution, the traceability, accountability and control that you gain over your clinical study is significant. Paper-based studies are cumbersome and tedious and allow room for too many errors. Title21 manages every aspect and component of the clinical trial from patient in-take to patient exit of trial while leveraging the benefits of an electronic system with reminders, trending, sophisticated and complex reporting made simple and accessible. Title21 Software is being used to support a clinical trial at Hoag Cancer center in Newport Beach, California to develop a vaccine for cancer patients. This application demonstrates the dynamic, sophisticated and powerful nature of Title21 Software’s platform.

T21 Mobile Technology is a powerful and easy-to-use technology that allows users to download and use, in an off-line/disconnected mode, the same forms and SOPs they use when connected to the network. This benefit eliminates the need for retraining on different data-input interfaces (e.g. Excel worksheets, etc.) during your disconnected mobile draws or other off-site work. Upon reconnecting to the network, completed forms are automatically uploaded to the main database. Other systems depend on Excel worksheets as a substitute for their on-line forms when disconnected, potentially compromising 21CFR Part 11 compliance in the process. T21 Mobile fully supports 21CFR Part 11 when disconnected, and all while using the same forms in which your staff already been trained.

T21 Mobile is very powerful and easy-to-use technology that allows you to download your same SOPs, workflows, forms and documents to work off-line, so it eliminates the need for retraining on different processes and forms for your mobile draws. Your off-line work is automatically uploaded to the main database next time you reconnect.

T21 Mobile delivers the identical off-line user experience as on-line users. This allows users to apply their same skills and knowledge for data entry regardless of an internet connection, eliminating any learning curve for off-line use. Form functionality (any form, not just PIFs) is identical to off-line users including attaching files, assigning tasks, field-level security, field-level help, field-level/cell-level validation, audit log and event searches. In addition, documents from the document control system can be automatically downloaded to the off-line user’s PC.

T21 Mobile ensures 21CFR Part 11 compliance (electronic records and signatures) for off-line users and is the only system that meets this FDA requirement for off-line users. This critical differentiator is due to the fact that Title21 Software Quality Manager and T21 Mobile are built on the same platform technology. T21 Mobile ensures compliance throughout the entire process from off-line form completion to uploading the data to the main database (e.g. full audit trail, electronic signatures and full security, all while off-line).  Please note that ancillary “add-ons” such as the use of PDFs or spreadsheets for off-line data-entry should be verified that these approaches meet 21CFR Part 11 regulatory requirements.

T21 Mobile automatically checks to make sure your mobile units have updated SOPs and forms before they leave the center for a blood drive. If there are updates, the system automatically downloads them to the mobile unit. Users do not require connectivity to fill out the forms. When the mobile unit comes back to the center and connects back into your network, the software automatically uploads any new data into the system. Note that the software fully supports the requirements of 21 CFR Part 11 while in the disconnected/mobile state (e.g. full security, audit log, electronic signature, etc.) alleviating the risks of being out of compliance for your mobile entered data. This is an important point of differentiation from our competitor’s products that rely on simple Excel spreadsheets or similar data entry methods which do not have these required 21 CFR part 11 functions. Another important advantage of T21 Mobile is that the forms the mobile units complete are identical to the forms they use while online, so no retraining is required.

Docs-on-Disk™

Title21 Software’s Docs-on-Disk™ solution exports and maintains documents that are contained within the Document Control solution to a designated directory on the network. This convenient utility helps you manage downtime procedures by automatically exporting documents from the Title21 Software system to a network directory, allowing users to view controlled documents in a Read-only PDF format, or optionally, in the documents native format. 

Docs-on-Disk provides for the availability and access to documents during network downtime, as well as facilitating a process for the maintenance of documents on mobile PC/Laptops. Users can view controlled and up-to-date documents thereby helping to ensure conformance and compliance in a regulated environment.