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WHITE PAPERS AND CASE STUDIES

• A Guide to Annex 1 Requirements For Particle Monitoring

  The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.

• Trend Analysis Of Total And Viable Particle Monitoring Data And Definition Of Alert And Action Limits

  Routine review and analysis of environmental monitoring data for trends at an appropriate frequency is essential to aid in the interpretation of process stability and assess overall environmental control performance.

• MSP Saves $75k With Liongard

  Established in 2001, ES Consulting takes a holistic approach to serving its customers and helping them grow. This includes extensive industry expertise, adherence to best practices, and investing in its infrastructure to automate for greater efficiency. The nationally renowned MSP has been featured on Inc.’s lists of Best Workplaces and Top 5,000 fastest-growing privately held companies, and has become a mainstay on Channel Futures’ MSP 501 annual list of top managed service providers in the world.

• Alnylam Puts Sites And Patients First With IQVIA Technologies Investigator Site Portal

  When Alnylam Pharmaceuticals began development of medicines for rare diseases with few or no treatment options, the company’s leaders knew they needed to design clinical trials that kept patient well-being and disease burden at the forefront. As Alnylam’s first clinical program began in 2014, the study team saw emerging site-facing technologies as a foundation for those trusted relationships, starting with a purpose-built communication channel and easy-to-use study conduct tools to support a complex protocol.

• InfoAsset Planner Helps The Largest US Water And Wastewater Utility Save 10% A Year

  Large utilities need to maintain high levels of service when it comes to water and wastewater systems. If they do not they risk failures, fines, and costly reactive maintenance. This specific organization was looking to find a solution that could improve decision support models and monitoring data integrity.

• Phase Stability, Loss Stability, And Shielding Effectiveness

  This white paper addresses phase stability, loss stability, and shielding effectiveness in cable assemblies exceeding 20 feet. Stability and shielding effectiveness behavior in such assemblies are not well documented due to low demand for such assembly types and the lack of standardized test procedures. 

• Artificial Intelligence Can Boost Reliability And Speed Of Medical Imaging Analysis In Clinical Trials

  Pharmaceutical firms face many challenges in bringing their products through clinical trials — from enrollment delays to data quality issues — and every advantage can make a difference. In image analysis, sponsors can gain a critical advantage by leveraging artificial intelligence (AI) or machine learning (ML) — computer solutions that mimic human intelligence and are continually enhanced and updated to become more accurate as they take in more data.

• Evidence Generation Strategic Partnership For Heart Failure Studies

  Read how a pharmaceutical support services company helped a large pharmaceutical company manage a portfolio of 5 heart failure studies, with over 500 investigator sites and 7,000 patients, to accompany an evidence generation program for a new product launch.

• AI-Assisted Indexing Improves TMF Management

  The timely and accurate filing and indexing of documents for the Trial Master File is one of the most significant compliance challenges facing organizations today. In this case study, learn how Phlexglobal’s advanced machine learning technologies reduced a pharmaceutical company’s document processing time by 16% while maintaining 98% accuracy.

• Carbonite Endpoint Encryption: An In-Depth Look At The Encryption Technology Behind Our Premium Endpoint Backup Solution

  As one of our core pillars, addressing the end-to-end security and privacy of data is a primary requirement of Carbonite Endpoint. By utilizing our automated key management and encryption technology in conjunction with our unique data deduplication, both efficiency of data deduplication and security of data can be accomplished. This document describes the end-to-end encryption process and encryption key life cycle management.

• Meeting Quality Standards With Multiple Global Manufacturing Locations

  With 66 global locations from Kansas to Krakow, Fagron needed a way to ensure each facility could stay in compliance with the regulations of every market they serve. The variety of processing by regulating authorities based on the country led to inconsistent processes. By implementing a software solution the team has reduced over 450 hours per year spent on preparing paper-based training materials, saving more than 500 sheets of paper per week at those sites.

• Seal-Scan Medical Device Case Study

  High product costs and superior quality requirements are the two single reasons for successful integration of airborne ultrasound seal inspection for medical device packaging. This case study focuses on the use of Seal-Scan® for final seal quality verification for an implantable sterilized medical device.