Compliance

WHITE PAPERS AND CASE STUDIES

• Have Confidence In Your Bio/Pharma Data

  The pharmaceutical industry has grown from simple aspirins to IV delivery, antibiotics and, most recently, cell and gene therapy. Products are more complex, tailored and varied than ever and the associated amount of data is growing - which requires a new level of attention to detail. Learn what features tolook for when choosing a data management system to establish compliant data visibility across teams, sites and partners and establish data integrity throughout the product life cycle.

• Ensuring On-Time Release Of CAR-T Cell Treatment In Spain

  Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.

• Nemours Children's Health System Enhances Patient Experience With HID Global EPCS Solution

  HID Global Solution Enables DEA-compliant Electronic Prescriptions of Controlled Substances (EPCS)

• Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
• Replacing A Paper-Based GMP System With An Electronic Monitoring System

  As a trusted source of innovative solutions in clinical diagnostics, Fujirebio Diagnostics' sought to replace an its paper-based GMP record system and manual process with an electronic monitoring system.

• Focus On Your Core Business Strategy

  Learn how a large manufacturing client helped to focus on their core business with a solution that transitioned approximately 60% of the workforce and capitalized on the initial training investment.

• GFI Case Study: Montclair Board of Education Montclair Public School District, is recognized by the United States Department of Education as one of the six best magnet school districts in the country with a group of schools falling under this umbrella name that accept students ranging from ages 5–16. Over 2,000 employees using email extensively and with...
• TEDS Releases Compliance And Competencies Case Study On Dominion Resources. By Bersin & Associates' Chris Howard, Principal Analyst. TEDS, originator of the only fully integrated enterprise-wide talent management solution, recently released a case study highlighting the strength of its powerful LMS, Learning on Demand and TEDS RTC Power, a highly robust compliance and competency management tool
• TAKE Solutions' Team Announces Conatus Pharmaceuticals The Winner In PharmaReady Best Case Study Contest Recently, TAKE Solutions' PharmaReady team announced Conatus Pharmaceuticals the winner in its best case study contest. Of the numerous award submissions, Conatus won by presenting a detailed look into their search for an eSubmissions solution, including their initial criteria, marketplace comparisons and the end results.
• Accelerated Development Of Solid Oral Dosage Formulation For IND Submission

  This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

• Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA. Submitted by PANalytical
• Tickford Engelhard Makes Catalyst Conform w/o Recalibrating An automaker in the Far East had a mature 2-L model that already met the U.S. transitional low-emissions-vehicle (TLEV) standards...