Title21 Software offers a smarter software solution for Life Science firms. Title21 Software Quality Manager is the most user-friendly, turn-key quality management platform with Document Control, Quality Data Management and Training modules. Whether you prefer to tailor our pre-configured, out-of-the box solutions or configure a specific solution, you will improve quality and compliance while realizing a faster ROI.
Our unique Business Process Management platform manages any of your processes, so you realize the benefits of control, visibility, measurement, quality, compliance and accountability. Our feature-rich system ensures communication is timely; information is accessible; redundancy is eliminated; and loops are closed. Our familiar tools enable solutions to be implemented with ease and speed. And our products were designed for firms in FDA and ISO regulated environments. Accordingly, our software is 21 CFR Part 11 compliant.
Notable features include WYSIWYG (what-you-see-is-what-you-get) “drag-and-drop” forms and process design, Personnel Dashboards, automated report creation and distribution, trending, automatic e-mail notifications and escalations as well as a full security model. Title21 Software allows seamless integration with ERP, MRP, LIMS, EDMS or CRM system.
Industry Solutions:
Document Control, Training, Customer Complaints, Call Center, CAPA, Investigations, Equipment Calibration and Maintenance, Audits, Change Control, Deviations, Adverse Events
Medical Device Solutions:
DHR (Incoming inspection, in-process and Finished Device inspection/test), Risk Management, Design Controls, Supplier Control, Non-conforming Product/MRB, ECR/ECO’s, Field Service, Return Material Processing, Traceability, Service Records
Pharma/Biologics Solutions:
Clinical Trials Data Management (Study/Protocol development/review, site management, CRF, etc.), Batch Records; OOS, Post-market surveillance, COA
Specialties
Process Improvement, Learning Management, Document Management, Cell Therapy, Business Process Management, Cloud Saas