Industries
For over a decade, Title21 Software has been providing powerful solutions to companies in regulated industries such as biologics, medical device, pharmaceuticals, laboratories, hospitals, etc. Title21 specializes in compliance, quality, BPM and training solutions for companies regulated by the FDA, CAP, AABB, and other governing agencies.
Testimonials
"Title21 Software is a dynamic and innovative company. They anticipate the needs and listen to the voice of the customer. When we suggest an idea, they listen and respond with a solution. Title21 Software, a true partner in every sense of the word."
Abe Garcia
Miller Keystone Blood Center
"We have streamlined our document control process and have increased accountability within our quality department. Finding, tracking and reporting is effortless and T21 has been extremely responsive to our requests during the installation, through the validation and post go-live. T21 has met all of our needs and we would chose them again in a heartbeat!"
Nicole Liautaud
QA Associate
Stanford Blood Center
"Title21 Software reconfigured our system based on our changing requirements and were extremely responsive. Title21 was able to meet our requirements and aggressive timeline. It's reassuring to know that we invested in a system and a company that is able and willing to respond to our dynamic business needs."
Ken Hall
Director, Information Technology
Blood Bank of Delmarva
"We were amazed how much Title21 Software could do. They met all of our requirements to manage a lot of complex data and reporting for our clinical trial for cancer vaccine development. I’ve recommended them to colleagues at other research labs without reservation and I’d purchase their software again."
Linda D. Beutel, B.S.
Program Manager
Regulatory Compliance and Quality Assurance
Cell Biology Laboratory
Hoag Memorial Hospital Presbyterian
Cancer Institute
"Working with the people at Title21 has been a great experience. I've learned a lot and I'm looking forward to putting all of our processes into Quality Manager."
Joann Evans
Quality Systems Manager
Bonfils Blood Center
"We launched Title21 Software's Quality Manager in January 2007 and it has made a huge impact in the way our QA group conducts business at Palatin Technologies. QM installation had minimal interruption to our IT staff and integrated seamless with our current network. We are currently using the software to handle all deviations, change requests, CAPA's and document management including SOPs, specifications, protocols, reports, etc. Training was well received, users were pleased with how easy it is to access information and I was quite surprised how fast employees adjusted to the new system. The system is making everyone at Palatin more accountable with respect to quality; it is becoming a great tool for reporting metrics, and it is allowing us to focus on other areas of continuous improvement. Quality Manager was the solution we needed to assure Palatin maintains a high level of compliance."
Nicole Pederson
Quality Assurance Compliance Manager
Palatin Technologies, Inc
"We've been using Title21 Software's Quality Manager since January 2006 and we've been extremely pleased with our increased productivity. Quality Manager allowed us to virtually eliminate the paper documentation associated with our Device History Record by letting users input the various data directly into the system. Its unique capability to accurately reproduce our paper forms into an electronic version minimizes the training needed for operators to use the system. Plus, we've also implemented Quality Manager to capture our Return/Repair, Customer Complaint and CAPA systems into a single, comprehensive system that facilitates tracking, linking, processing and trending. Data is maintained in a secure environment and is available with just a few mouse clicks."
Jesse Gasaway
RA/QA Director
SSCOR, Inc.
"Title21 Software has allowed us to take our customer issue, complaint and corrective action processes to the next level. It has improved the responsiveness to our customers and has significantly decreased the number of man-hours spent on processing customer issues..."
Eric Earnst
Engineering Manager
Healthcare/Hospitals
Title21 Software is implemented and live at large healthcare institutions. From Cell Biology Labs to a Clinical Trial Labs, Title21 Software offers a wide variety of capabilities to automate processes, documents and training. T21 allows you to manage any process across departments and hospital sites with the flexible and dynamic solution to achieve compliance and harmonization. Some of Title21 Software partners include Hoag Memorial Hospital and Washington Hospital, Medstar Health.
Blood, Tissue, and Biologics
Title21 Software is the exclusive preferred Quality Management Solutions of Group Services for America’s Blood Centers, GSABC. Title21 Software is the leader and preferred solution in serving major blood centers and labs across the county.
Title21 Software Partners:
- Bonfils Blood Center
- Blood Bank of Delmarva
- Community Blood Center, Kansas City
- Indiana University
- Institute for Transfusion Medicine- ITxM, Central Blood Bank of Pittsburgh, LifeSource
- LifeShare
- Lifeblood
- Miller Keystone Blood Center
- Mississippi Valley Regional Blood Center
- Northern California Community Blood Bank
- Rock River Valley Blood Center
- San Diego Blood Center
- Stanford Blood Center
- QualTex Laboratories
Cell Therapy
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!
Manage your cell therapy lab with a powerful solution that is able to expand your labs capacity and grow with your lab as your requirements may change. Schedule a demo to see what is possible and ready to implement in your lab.
Medical Device
Title21 Software helps medical device manufactures define and automate their processes like Design Review, Change Control, Device History Records, and Audits to help them gain their Pre Market Approval from the FDA. The powerful and agile solution also handles Incoming and In-Process Inspections, Non-Conformance Reporting and Recalls. So no matter what your business need may be and no matter how complex your requirements may be, Title21 Software can provide a best-in-class solution that delivers on your unique set of requirements. Title21 Software has been successfully running at Medtronics Ablation Frontiers, and SSCOR medical device companies to help them manage their change control, design history, training, document control, audits and many other processes.
Pharmaceuticals
Compliance is critical in maintaining compliance and attaining approvals. Title21 offers a complete and integrated solution for pharmaceutical company to help manage revision-controlled documents, SOPs, training and any process. Title21 Software helps pharmaceutical companies, both small and large, gain their pre-market approval and to be well-prepared for FDA inspections.
Contract Research Organizations
Title21 Software offers a complete solution for CROs to help manage and comply with the varied regulations and sponsor requirements demanded of your organization. From controlling documents and SOPs, studies, equipment maintenance and managing audits, CROs can rely on Title21 Software as their go-to solution to improve productivity and compliance, leading to better inspection and audit outcomes. Title21 Software solutions give you the control, visibility, accountability and traceability that the your organization demands
Neutraceutical
Compliance is also important in the Neutraceutical vertical. Title21 Software can support Document Management, Change Requests, Product Development, and Inventory Management to ensure compliance, deliver quality and improve profitability.
Food & Beverage
Ensure compliance, deliver quality and secure brand protection with a system that helps manage your HACCP, Recipe Development, Recall process and many other processes. Title21 Software is easy to implement the out of the box templates or Title21 will configure and automate your paper process.
|
