Regulatory Compliance Solutions

  1. Compliance Program For EU Annex 1 Container Closure Requirements

    Discover a program designed to comply with Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. This holistic, science-based approach generates robust data throughout the product life cycle.

  2. Process Safety, Dust Explosion Testing Capabilities 6/18/2025

    Ensure safer, scalable chemical processes by integrating "Safety by Design" with expert process hazard analysis and robust risk mitigation from development through commercial manufacturing.

  3. MultiWash+ Microplate 96- And 384-Well Automated Washers 6/20/2023

    Compact microplate washer with maximum flexibility in a minimum footprint

    The MultiWash+™ Microplate Washer is an automated, compact, quiet, efficient washer with 20 different wash protocol options. The variations include adjustable speed and volume, adjustable aspiration speed and time, adjustable soak times, and three modes of shaking. Four wash/rinse bottles are included and configurable for both 96- and 384-well plates.

  4. Biopharma Manufacturing Process Data Made Simple 9/6/2023

    PIMS makes BioPharma manufacturing process data accessible, transferable and meaningful

  5. Organoid-Based Drug Screening Services 6/20/2025

    With a focus on scientific rigor and adaptability, our organoid solutions empower researchers to optimize candidate selection and accelerate development timelines.

  6. IDBS PIMS And Regulatory Compliance 4/4/2025

    Approach for US FDA 21 CFR Part 11 electronic records and electronic signatures: IDBS PIMS has been designed, developed and tested to enable compliance to 21 CFR Part 11 to accommodate the regulatory needs of its users.

  7. 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.

  8. Corrective Action Preventive Action (CAPA) Software For Life Sciences 8/23/2021

    Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

  9. An Introduction To Validation Of Aseptic Fill/Finish And Related Processes 12/27/2024

    Discover innovative monitoring solutions for aseptic filling processes, ensuring sterility through equipment, environment, and product validation to optimize safety and regulatory compliance.

  10. Software To Automate And Digitalize Data Recording Steps In QC Workflows 5/2/2023

    Explore the technicalities of the M-Trace™ Electronic Test Record Software, a solution that automizes and digitalizes all data recording steps during sterility testing and other quality control workflows.