Newsletter | September 18, 2020

09.18.20 -- Process Data Management Strategies For Clinical And Commercial Manufacturing

 
Using Software Systems To Drive A Successful CPV Program
 

An area of life sciences that has recently received significant attention around data, its integrity, and its management processes, is manufacturing. This article covers pharma manufacturing data management systems, with insights on how purpose-built systems incorporated into your continued process verification (CPV) program meet FDA requirements and protect your business.

Optimizing Processes And Accelerating Success In Cell And Gene Therapy Development And Manufacturing
 

Cell and gene therapy companies are rapidly moving toward larger scale manufacturing operations. Adopting a process information system that creates a digital data spine early in process and product development to establish a persistent, dynamic knowledge library throughout the product life cycle is critical to cell and gene therapy development, commercialization, and wide scale adoption.

Key Factors For Successful Technology Transfer
 

Successful technology transfer is reliant on a few key variables including robust process characterization and communication and collaboration among multiple teams and sites. The key determinant to achieving success is the exchange of accurate, compliant data in a relevant time frame.

How To Establish Process Data Visibility In Contract Manufacturing Networks
 

This webinar explores the challenges within today’s increasingly decentralized and complex supply chain and how sponsors and CDMOs plan to address them. Examples of client business cases utilizing a data collaboration platform are also presented.

Selecting The Right Tool For Product-Process Data Management, Moving Beyond Excel
 

The use of spreadsheets in life sciences development and manufacturing carries high tangible costs that may not be so obvious: manual data entry, competing data sets entered by different users, version control, security, and delayed data migration to Part 11 compliant systems. Learn how a data management tool that rapidly integrates with multiple commercial products can simplify your processes.

How Data Collaboration Is Helping Novavax Accelerate Vaccine Production
 

Driven by its COVID-19 vaccine development and manufacturing data management complexities, this late-stage biotechnology company wanted to harden its data infrastructure, discontinue wide-scale use of Excel for batch/process/product data management, and accelerate data sharing among a large external network. A data collaboration platform was their solution.