Regulatory Compliance Solutions

  1. A QMS Software That Enhances Operational Excellence 3/24/2025

    Ideagen Quality Management is a modular SaaS solution designed with the needs of quality managers in mind. Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards.

  2. Enterprise Maintenance Management 8/8/2025

    Streamline maintenance with a paperless platform that boosts uptime, ensures GMP compliance, and improves efficiency through automation, mobility, and KPI-driven insights.

  3. Manufacture High-Quality Products With Streamlined Compliance 6/26/2025

    Manufacture high-quality products with streamlined compliance.

  4. Increase Employee Retention And Compliance By Investing In Quality Training From Waters 7/14/2022

    Learn how to utilize enabling technologies, including instruments, informatics, and chemistry/consumables with our budget-friendly educational services.

  5. A First-Of-Its-Kind Advanced Qualification Dossier 10/29/2024

    This unique and comprehensive “On-Demand” dossier is designed to address the qualification requirements and provide all the information needed for your specific assembly in one location.

  6. Rapid Sterility Testing: Actionable Results In Less Than 5 Hours 6/20/2024

    Use a real-time PCR (qPCR) solution for testing cell therapy products that provides sterility results in less than 5 hours.

  7. Cleanrooms And Equipment For 503B Outsourcing Facilities 6/9/2023

    Germfree understands the unique challenges associated with 503B sterile drug compounding

    Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.

  8. As Biopharma Advances, So Must Our Data Integrity 10/4/2024

    Therapies 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.

  9. Partner With The Experts In Annex 1 10/15/2024

    Prepare for Annex 1 compliance with expert-led support in contamination control, featuring solutions that cover risk assessment, validation, and training to ensure cleanroom safety and compliance.

  10. Adopting Enabling Informatics Technologies To Drive Digital Transformation And Data Integrity 7/14/2022

    Learn how to transform your contract organization into a completely paperless, connected lab with our informatics solutions, which deliver robust, proven results and reduce regulatory risk.