University of Minnesota Molecular and Cellular Therapeutics Unit enters technology partnership with Title21 Health Solutions to support quality process control and high-quality manufacturing of cGMP and cGTP biotherapeutic products
April 26, 2018 – Pleasanton, CA – Title21 Health Solutions, “Title21”, a provider of integrated enterprise software solutions supporting the health sciences to provide high-quality and world-class patient care announces its selection as the enterprise technology partner to support University of Minnesota’s Molecular and Cellular Therapeutics Unit (MCT).
“The Molecular and Cellular Therapeutics, a biotherapeutic manufacturing facility at the University of Minnesota, has selected Title21 as a service provider of an electronic quality system database,” stated Diane Kadidlo, MCT Facility Director. “In early 2017, we embarked on a comprehensive evaluation of commercial quality system software and after much consideration we decided upon Title21’s software primarily because their database package included multiple quality system modules that are integrated and configurable to our internal processes and their ability to meet FDA 21 CFR part 11 requirements.”
Title21’s configurable and integrated platform delivers process control and workflow management, promotes regulatory compliance, and facilitates faster, safer, manufacturing and product development. Clinical programs and manufacturers can meet current and future process control needs with an electronic solution focused on compliance, efficiency and, most importantly, patient safety. Integrated modules in the Title21 EQMS platform include Equipment Maintenance & Calibration, Training Management, Document Control, Change Management, Audit Management and more.
In addition to enterprise quality management software, Title21 delivers specialized electronic solutions to support regenerative medicine, cell and gene therapy operations to manage diverse data sets and processes across clinical and laboratory operations. This combination of technical capabilities and focus enables blood and marrow transplant programs as well as cell and gene therapy firms to utilize an integrated electronic strategy to reduce paperwork, improve efficiency and compliance throughout their operation.
“Title21 is dedicated to working with industry members who are at the forefront of advancing treatment options and improving patient care. Our goal is to support organizations like University of Minnesota to compress development timelines and support high quality operations throughout the translation of research into novel clinical products that improve patient care and outcomes,” remarked Lynn Fischer, Title21 CEO.
Title21 maintains a unique position in the cell, gene and regenerative medicine software marketplace as the sole technology provider capable of data management across core operations beyond quality management, including clinical, laboratory, supplies, equipment and inventory. The software’s ability to replace paper with electronic forms, integrate with clinical systems through HL7 channels, and print ISBT 128 compliant labels streamlines workflow and enables more time and focus on innovation and patient care.