Driving innovation and quality simultaneously is a common challenge biotechnology companies face today. These organizations face a multitude of challenges in product development, manufacturing operations, and regulatory compliance, that all include the ever increasing need for faster throughput, higher quality and achieving required cost objectives. In fact, the need in biotech has never been greater for the use of supporting technologies to create a solid foundation and provide for an integrated framework in the development and manufacturing of safe and effective products. San Francisco Bay Area-based Title21 Health Solutions is a company who partners with biotech firms to leverage the power of technology to overcome these important challenges.
Title21 Health Solutions delivers easy-to-use software designed for the biotech industry, with comprehensive systems for operations and laboratory management, document control, quality management, and more. This intuitive technology is designed to speed innovation, improve efficiencies, support compliance and ultimately further life science advancements. Title21 has developed a unique technology offering, taking the “best of both worlds” by harmonizing the ease and accessibility of a cloud-based system with the power and flexibility of a configurable desk-top platform. Each of these interfaces share a common and secure database. This approach is one of the many reasons CIOReview is recognizing Title21 Health Solutions as a Top 20 Most Promising Technologies in Biotech for the second year in a row.
Title21 Health Solutions’ CEO Lynn Fischer described, “Title21 provides a comprehensive platform that automates all compliance-driven processes with a single user log-in, while helping biotech organizations to develop new therapies and products quickly–which are safe and comply with applicable regulations.” All Title21 solutions support 21 CFR Part 11 with electronic signatures, personalized permissions based on a user’s role(s) and a full audit log to ensure inspection readiness. “We provide a solution which enables management to review key performance indicators, conduct reviews and approvals with electronic signatures from the convenience of a web browser, iPad or tablet from anywhere. Data can be accessed and critical tasks can be performed in a few clicks.”
The Power of an Integrated Platform
Title21 solutions are natively integrated in a secure database to facilitate seamless data-sharing among the modules. For example, the Laboratory and Operations Data Management modules communicate directly with the Supplies Module to ensure expired supplies or reagents are not erroneously consumed, or that an out-of-calibration or overdue-on-maintenance piece of equipment is not used. The Customer Complaint Module can initiate investigations and generate corrective actions. Corrective actions can subsequently drive retraining with just a few clicks. Title21 provides the flexibility and scalability to automate one or many complex processes in a simple, user-friendly manner.
“Despite being an industry that thrives on innovation, many biotech firms are manually managing their data through a combination of paper, Excel spreadsheets or homegrown databases.
Title21 solutions are natively integrated in a secure database to facilitate seamless data-sharing among the modules
For those organizations that have implemented some form of an electronic solution, they are invariably implemented as point solutions that cannot share data; commonly referred to as a ‘Data-Silo’. Biotech firms have the need to track, trend and report on data across a multitude of processes, which is a burdensome task if the data is dispersed. Time spent tracking down paper and manually compiling data is time that highly-skilled scientists, technologists and researchers can spend on higher-order work,” explained Lynn.
There are compliance benefits to using an integrated information system. “When disparate technology systems don’t share data, people become the de-facto integrators. Wherever people are shuttling data across systems, there lies potential for compliance gaps and human errors. The possibility for transcription errors or miscalculations undermines the data’s integrity,” explained Fischer. Title21 users only need to learn one system with a single log-in which integrates with Active Directory and manage their work through a consolidated and personalized dashboard. Title21 also offers capabilities to integrate with lab instruments and other electronic systems to push or pull data. “We are customer-centric and believe that validated data should be entered only once.” Title21 deployments include trend alerts, powerful search capabilities, and reports, so the data can be quickly analyzed and managed.
User Adoption is the Key
Title21 recognizes that user adoption is the critical success factor in any software deployment. Ease-of-use is a consistent hallmark of the Title21 system. Functions are implemented to minimize the number of clicks for any given task. All users have their own Dashboard that brings everything they need to perform today together in one place. This design approach results in a shorter learning curve for the user, further enhancing user adoption. “Thanks to our intuitive technology, a well-defined deployment process and our great team, every deployment has been a success with enthusiastic user adoption,”remarked Fischer.
The Need for Speed
In the fast-paced world of biotech, the need to deliver an ROI quickly is critical. Title21 Health Solutions accelerates the ROI through rapid deployments. Customers can utilize Title21’s best-in-class workflows and form templates designed specifically for the biotech industry. “We have streamlined deployments, so we can implement as fast as the customer’s time-line requires” explained Fischer. “Our best-in-class workflows and form templates enable our partners to quickly standardize their processes by utilizing pre-configured solutions that we developed over many years.”
Another benefit that helps biotech firms hit the ground running is Title21’s flexible delivery options, including their SaaS model with their private cloud-based hosting. “We provide the option to deploy the solution on premise or we can host the solutions with our private cloud offering,” said Fischer. “If an organization needs to lean on us for IT support, we support them to make it as easy as possible.”
Title21 Health Solutions’ private cloud differs from the typical cloud offerings because it provides customers complete control over the timing of updates and upgrades. Fischer continued, “In a regulated environment, any updates of validated systems need to be controlled and coordinated on the customer’s time-table.”
Designed for Regulatory Compliance
“Advancing medicine and therapies to improve health care has been our true north since our inception,” remarked Fischer. “All of our solutions are designed specifically for the requirements of health sciences. We have strong expertise and experience with the specific regulations and standards. Biotech organizations are well-prepared for audits and inspections with Title21, because the solutions store all necessary records and documentation needed while users are prompted to stay up-to-date on the necessary compliance tasks.”
At the Forefront in Support of Regenerative Medicine Sciences
Title21 Health Solutions has been delivering integrated and easy-to-use data management solutions for nearly two decades, with a strong focus in recent years towards innovations in the cellular therapy and regenerative medicine space. In 2014, Title21 launched its Title21 Cellular Therapy Solution, which enables complete electronic data management and automation of the complex workflows of a cellular therapy environment spanning from clinical data management, laboratory processing, inventory management and more. “In regenerative medicine, organizations need to leverage the power of technology to create more efficient and streamlined processes,” explained Lynn. “Our technology advancements to support regenerative medicine have translated into robust functionality that simplifies the complexity of the user’s work. The more sophisticated and complex the processes, the greater the opportunity to capitalize on our powerful technology to handle the calculations, algorithms, business rules, tracking, trending and reporting to maximize the organization’s performance and throughput.”
Long-Term Partnerships are the Foundation of the Title21 Experience
Title21 Health Solutions recognizes that a long-term strategic partnership is the key for an organization to maximize their investment with a vendor’s technology platform. This philosophy applied consistently over time has allowed Title21 and its partners to partner in a productive and collaborative framework to solve the organization’s most challenging and complex problems with elegant, easy-to-use solutions. Title21’s strong commitment, innovative technology and outstanding support of the biotechnology industry are some of the many reasons CIOReview is recognizing Title21 Health Solutions as a Top 20 Most Promising Technologies in Biotech for the second year in a row.