The advent of more widely distributed supply chains demands greater investment in tools, expertise, and most importantly, human capital," said President Gary Hutchinson.
HOUSTON, Texas (PRWEB) September 18, 2018
Modality Solutions cold chain experts recently published and made available for free its new Cold Chain Process Validation Guide. The full-service engineering firm saw a need to address cold chain drug product process validation for the handling, storage, transportation, and global distribution for life sciences industries. The principles presented in the guide apply to the validation of a pharmaceutical, biologic or combination medical device in today’s regulatory environment.
With Modality Solutions, three types of firms – cold chain regulatory filing authority, logistics network operations, and an integrated expertise staffing firm – combine as a single source of cold chain management engineering for the life sciences industry. Its new Cold Chain Process Validation Guide is intended to help cold chain logistics teams make sure their product supply chain handling processes are being performed appropriately for temperature, humidity, pressure, shock, vibration and other relevant environmental conditions.
The validation guide supports global cold chain regulatory requirements and addresses economic and regulatory pressures, accelerating costs, technology changes and the need to constantly adapt the business model. It provides solutions that deliver value while enhancing your regulatory reputation. It helps management see how to integrate its cold chain network to ensure all processes are working together to achieve the common goal of delivering quality medicines to the patients who need them.
The Cold Chain Process Validation Guide provides:
- Appropriate expertise and techniques to assess, control, and communicate risk as part of an ongoing management review process.
- A lifecycle approach to process validation including design, qualification, and verification.
- Better integration of product formulation, controlled environment logistics, and packaging design.
- Innovative, forward-looking quality controls, corrective and preventive actions (CAPAs) strategies, and root cause analyses for once straightforward processes that are highly complex today.
- Application of technology to achieve greater gains in all areas, including compliance, quality, and safety.
“Competing priorities, changing expectations, cost pressures, sustainability initiatives, emerging markets--these are just some of the challenges facing cold chain management professionals every day,” said Modality Solutions President Gary Hutchinson. “The advent of more widely distributed supply chains demands greater investment in tools, expertise, and most importantly, human capital. For this reason, we pooled our expertise, knowledge and industry resources to create this important guide.”
Click here to download the Cold Chain Process Validation Guide.
For more information about Modality Solutions, visit https://www.modality-solutions.com
About Modality Solutions, LLC
Founded in 2011 Modality Solutions integrates cold chain operations systems ensuring regulatory compliance, product quality, and patient safety by combining best practices of process validation, systems qualification, and risk assessment. Modality Solutions delivers proper documentation for qualification, validation and training aligned with the necessary procedural controls, visual controls, and monitoring. Key areas of service are: ensuring regulatory compliance; delivering cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conducting transport simulation testing; providing staffing augmentation; decreasing development cycle times for a faster route-to-market; developing transport validation strategies to support global regulatory applications; and clinical trial operations. For more information, visit https://www.modality-solutions.com.