Compliance

WHITE PAPERS AND CASE STUDIES

• Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System When Peter J. Mueller, Manager of Global Quality Information Systems selected a global CAPA (Corrective and Preventive Action) system for his company, he knew exactly what he was looking for...
• Set Up And Qualify GMP Laboratories

  See how a GMP microbiology lab was established and qualified in Ireland, providing expertise, staffing, training, and project management to ensure compliant operations and client success.

• Become A High-Performing Clinical Site: Tools For Hospitals, Clinics, And Academic Centers

  This paper will give you the keys to set up a new clinical site, find the right model, pass the sponsors’ feasibility processes, acquire the right technologies, familiarize yourself with rules and regulations, and successfully mitigate risks.

• The Importance Of Quality In Raw Material Selection

  Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization. 

• Physicians Medical Group Cuts Processing Time With Datacap Taskmaster Physicians Medical Group of Santa Cruz County (PMG) cut its claims processing time by more than half and provided faster access to data, fewer compliance concerns, happier employees and more satisfied customers with an integrated solution from Datacap and Bowe Bell & Howell. Submitted by Datacap
• Strategic Hiring For Scalable Success

  Discover how a people-first talent strategy, purpose-driven culture, and cross-functional collaboration come together to support scalable growth and operational excellence in commercial manufacturing.

• Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot

  Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research efficiency.

• New EH&E White Paper Evaluates Web-based Environmental Health & Safety Training For Laboratory Applications A new free white paper entitled “The Role of Web-based Health and Safety Training in Laboratory Facilities,” is available to help companies, institutions, and universities evaluate the efficacy of using web-based environmental health and safety (EH&S) training to meet their compliance requirements
• 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
• 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)

• Case Study: 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.
• Data Collaboration Helps Novavax Accelerate Vaccine Production

  How and why this late-stage biotech implemented a data collaboration platform, Driven by its COVID-19 vaccine development and manufacturing data management complexities.