Business Process Management

WHITE PAPERS AND CASE STUDIES

• A Guide To Smart KPI Tracking For Service Companies Using Remote Visual Assistance

  Key metrics every service company should track for optimal data-driven decision making that supports core business objectives.

• Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up

  In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.

• The Secret Sauce In Successful Clinical Trial Payments Programs

  More than 80 percent of sites surveyed want to get paid in 30 days, and many clinical technology companies offer specialized software solutions to help manage several components of the site payments process. However, these systems still require a large effort by the sponsor to operate. What is the secret sauce for success?

• The Evolving Role Of The GxP Archivist

  Customers and regulators expect the highest level of data integrity. This white paper asserts that storing GLP data in the cloud is acceptable, provided certain conditions are met.

• Long-Term Simulation Scenarios, Compelling Visual Results, Accurate Flow Assessments

  Two wastewater treatment plants (WWTP) needed hydraulic model assessments, and plant managers needed to ensure their facilities could maintain water flows running at their current capacity and determine whether or not improvements were required.

• Engaging Stakeholders With Visualization And Analytics

  The National Pollutant Discharge Elimination System (NPDES) permit program, created in 1972 by the Clean Water Act (CWA), helps address water pollution by regulating point sources that discharge pollutants into the waters of the United States.

• Transforming From Supply-Led To A Demand-Led Model To Support Commercial Gene Therapies

  In gene therapies supply chains, the focus is entirely patient-centric and the ‘volumes’ can often be as low as 1 dose per batch/lot, so the supply and distribution model needs to be much more flexible and precise.

• How To Build A Modern Field Service Technology Stack

  To enable your field service organization to serve your customers better and faster, you need to utilize modern technology that defines and supports the execution of established processes and provides the flexibility required to evolve when those processes change. Doing so improves operations and customer satisfaction immediately, but it also positions your field service organization for long-term growth.

• Mechanistic Modeling Of Chromatography To Speed Up Process Development

  Catch up on the current opportunities and challenges for using mechanistic modeling to simulate and predict chromatographic behavior and experiments in silico. 

• Ensuring Compliance With Part 11: A Site’s Perspective

  As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.

• Removing The Barriers To eConsent Adoption

  eConsent technology has existed for nearly 20 years in various iterations. Read how sponsors have taken a cautious approach to using eConsent, piloting it on individual studies but refraining from incorporating it across all pipelines in clinical operations.

• Chemistry, Component Optimization In Early-Stage Development

  Learn why media chemistry optimization is an important consideration to ensure your cell culture medium can perform well at scale and support a high cell density.