As approved business partners, Modality Solutions and DeltaTrak will offer their life science customers implementation and validation services in conjunction with cold chain monitoring device technology in order to ensure regulatory compliance.
Modality Solutions, a company that delivers integrated cold chain management solutions for highly regulated industries, is pleased to announce its approved business partnership with DeltaTrak. The companies identified the need for life science companies using cold chain monitoring device technology to have both an implementation plan and validation process in place to ensure regulatory compliance.
Life science cold chain management is the plan, process, monitoring technology and validation of the supply and distribution of pharmaceuticals, vaccines, biologics, and medical device combination products. All of which must be kept at optimum temperature and humidity levels throughout storage and shipping cycles in order to maintain their efficacy. If, at any time a temperature-sensitive product is exposed to temperatures outside its defined range, irreversible damage can occur, resulting in loss of product, profit and ultimately patient safety.
Based on more than 100 combined years of career experience in the biotechnology and life science arena, Modality Solutions’ subject-matter experts play a leadership role in several industry-recognized associations (PDA and IQPC) and standards-based organizations (ISTA and ASTM). They integrate cold chain management solutions by providing insight into cold chain thermal package engineering, transport validation, and controlled-environment logistics. Modality Solutions delivers solutions that define and then minimize or eliminate transportation environmental hazards in the supply chain.
DeltaTrak offers front end devices and solutions for monitoring temperatures during storage, shipping and handling. Its in-transit data loggers record critical time and temperature data during transportation, with Shadow Log , a fail-safe feature that guarantees data recording even if the operator fails to activate the unit. In addition, DeltaTrak’s ColdTrak Data Central is a cloud-based software solution that provides validation and quality assurance functionality. It helps customers retrieve, view, analyze and share critical temperature data during transportation or facility storage throughout the world, 24/7, and it can send alerts to designated personnel via text message, email or voice mail when temperature excursions occur. The company’s FlashPDF software is designed to help download data loggers to PCs and then upload this information into a client’s ColdTrak account. This service allows a client to integrate data from its data loggers into existing 3rd party enterprise resource planning (ERP) and material requirements planning (MRP) systems used for purchasing, inventory control and manufacturing processes.
Having a value-added partner like Modality Solutions provides DeltaTrak clients with an applications solutions partner. Their implementation services ensure a compliant transition of technology, including qualification/validation, change control, and corrective actions and preventive actions (CAPA) management. In addition Modality Solutions can identify and validate new global routes and shipping lanes, as well as help with audit preparations and assistance on CAPAs from previous audits.
“Any temperature abuse, either above or below the safe limit, can result in compromised efficacy or even total loss of products,” said Modality Solutions President Gary Hutchinson. “DeltaTrak has the technology, and we have the expertise in cold chain implementation and validation. Partnering with DeltaTrak allows us to provide cost-effective in-transit monitoring solutions to help improve cold chain management from manufacturing to distribution.”
“Assuring the integrity of temperature sensitive products in all of the critical control points of a cold chain is imperative in today’s business world,” said DeltaTrak Director of Business Development, Peter Norton. “With Modality Solutions as an approved business partner, we are now able to enhance our clients’ reputations by ensuring regulatory compliance, product quality and consumer safety from discovery to distribution.”
About Modality Solutions
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. For more information, visit http://www.modality-solutions.com.
Founded in 1989, DeltaTrak is a leading innovator offering end-to-end cold chain management, environmental monitoring and food safety solutions for the food, pharmaceutical, life sciences and chemical industries. These include high quality instruments and cloud-based software and services, providing visibility of temperature conditions during storage, transport and handling of temperature sensitive commodities. For more information, visit http://www.deltatrak.com.
SOURCE: Modality Solutions