Regulatory Compliance Solutions

  1. 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.

  2. Out Of Specification (OOS) Software For Life Sciences 8/23/2021

    The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

  3. Pharmacovigilance 5/28/2024

    The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence. Our global and scalable safety solutions are designed to be efficient, affordable, and fully compliant, giving you flexibility and peace of mind in a complex clinical environment.

  4. Quality Management And Compliance Consulting 4/29/2024

    Explore an extensive range of GxP services spanning CQV, Technical Consulting & Training, Quality Systems & Compliance, and Auditing for seamless project delivery and strategic support.

  5. Cleaning Validation 4/27/2022

    Kymanox understands that cleaning validation, as with all CGMP activities, should be a controlled, quality-driven process that manages risk and ultimately ensures a safe and effective product for the patient. Our science-driven and planning-focused approach delivers Right First Time (RFT) results.

  6. Optimize Your Contamination Control Strategy 10/21/2024

    An optimized and effective Contamination Control Strategy (CCS) helps you organization spend less time cleaning and more time manufacturing. Ecolab Life Sciences experts are dedicated to helping you drive the best possible strategy to meet and exceed the GMO Annex 1 CCS requirements.

  7. Quality Assurance + Compliance 4/27/2022

    Kymanox has a diverse background covering biotechnology, pharmaceuticals, medical devices, in vitro diagnostics, and combination products. Turnkey solutions are available to support your objectives as you progress from early stage clinical development through commercialization and post-commercialization. Our experts can support specific projects or augment staffing for defined periods of time.

  8. Cleanrooms And Equipment For Cell Therapy Drug Manufacturing 6/9/2023

    Delivering on the promise of cell and gene therapy through Germfree products and services.

    Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.

  9. The Next Generation Of The Number One Enterprise Quality Management System (QMS) 9/2/2021

    MasterControl has been delivering quality excellence for over 25 years. We continue to improve our quality management solution to meet the needs of highly regulated industries - like life sciences - as they embrace new levels of digitization and automation and require quality management practices that are more dynamic, connected and scalable.

  10. Dynamic Vapor Sorption Analyzer 4/17/2023

    Discover a system for advanced engineering and attention to detail that provides enhancements in every aspect of DVS technology as well as a new level of user experience.