Compliance

PRODUCTS

  • Scaling your drug product from concept to commercial supply requires having the expertise to ask the right questions about your end goals, from the start.

  • At Ideagen, we're committed to empowering seamless collaboration and enhancing your document review process. Through strategic alliances with leading technology providers across the life science industry, we offer integrations that amplify the efficiency and effectiveness of your workflows.

  • PHCbi brand's 24.2 cu.ft (684 L) upright pharmacy refrigerator offers a practical solution for storage with adjustable shelves and a wide setpoint range for varying laboratory applications, including biomedical storage and processing. The interior layout makes it ideal for running experiments that require changeable shelf configurations. The shelves can be arranged to accommodate all heights, and deep and strong enough to hold processing equipment and most devices.

  • Enable co-location of cell culture media and buffer manufacturing and bioproduction with Krakatoa K500, the first bioreactor-scale pod-based manufacturing system. Produce up to 500 liters of sterile solutions on-demand in less than 3 hours.

  • When it comes to your fill-finish workflow, sterility and efficiency are key. Denest and renest with confidence! Our ready-to-use (RTU) denesting equipment is here to help you separate and reassemble your products with ease. Rest assured the Hull i-Dositecno Denesting Equipment is robust and efficient, so your sterile, clean, ready to fill (SCF) components are transported smoothly through your fill-finish workflow.

WHITE PAPERS AND CASE STUDIES

  • 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.
  • Safeguarding The Viability Of Pharmaceutical Samples Within 42 Hours

    The distribution of critical cell samples requires an agile strategy with contingency planning and regulatory expertise to ensure seamless delivery on-time and within specifications.

  • Managing Hospitality And Entertainment Spending The ability for hospitality and entertainment enterprises to effectively source, procure, and manage their spend must keep pace with the demand for promptness and compliance in supplier relationship management (SRM). Submitted by Epicor Software Corporation
  • Case Study: Success Of Saipan's Solid Waste Management System Serving As Example To Other South Pacific Islands An integrated solid waste management system implemented on the island of Saipan has proven so successful that other neighboring South Pacific islands may follow suit. The goal for a new solid waste system was to not only bring Saipan into compliance with federal environmental regulations, but also utilize state-of-the-art waste reduction and diversion technologies
  • Comparative Analysis For Non-IND Sites

    A cancer research organization that facilitates multi-national clinical trials was in the planning and coordination of a Phase III drug trial and wanted to expand the trial to include German sites. Conducted under an IND, the trial was going according to plan until German regulations changed.

     

     

  • Utility Companies Prepare for the Year 2000 Companies across the nation are working on Y2K compliance programs to prepare for 12:00 a.m. on Jan. 1, 2000...
  • Liquid Handling Solutions For Bulk Drug Substance Management

    How modern containment technologies optimize and streamline bulk drug substance management workflows while ensuring substance integrity and safety.

  • GFI Case Study: Elgin Community College Uses GFI MailArchiver To Comply With E-Discovery Laws Elgin Community College is an educational institution in Elgin, Illinois offering first-class education from certificate to degree level. Changes to compliance and e-discovery regulations meant that the college required a system that allowed it to be in a position to provide electronic data should it be required as evidence in a civil or criminal legal case. To this end, the College installed GFI MailArchiver, an email management and archiving software.
  • Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx
  • LP Execution: Train, Test, Comply An LP (loss prevention) training, testing, and compliance monitoring solution helped $2.2 billion Pep Boys reduce shrink by as much as 10% and cut DC accidents by 50%. Used with permission from Integrated Solutions For Retailers magazine
  • USP Acceptable TOC Levels For Pharmaceutical Water: How To Achieve Them? Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the Pharmaceutical industry must develop economical and competitive production and cleaning methods, which in turn will help the industry develop appropriate operational methods. Submitted by Shimadzu Scientific Instruments
  • White Paper: The 5 Pitfalls Of Implementing Project And Workflow Management Software The benefits of implementing an end-to-end project and workflow management system may seem like a panacea to executives and senior managers. Operational efficiencies and increased collaboration among employees may result, along with improved compliance and a comprehensive real-time view of operations for rapid executive decision making.

NEWS