Regulatory Compliance Solutions

  1. A Novel Platform for DNA-Seq Library Preparation 10/24/2025

    Efficiently prepare high-quality DNA libraries from ultralow inputs with a fast, automatable workflow to eliminate adaptor dimers, reduce cleanup steps, and achieve broad GC coverage.

  2. Moving Visual Inspection Into Pharma 4.0 With The Identifier Software 8/25/2025

    Move your visual inspection processes into the Pharma 4.0 era with a digital system that provides data integrity and full audit trails to aid in compliance.

  3. Single-Use Supply Chain: The Distinct Advantage Of The Advanced Central Management System (ACMS) 6/6/2022

    This fully validated solution to support a Quality by Design approach to single-use assembly design and production. It ensures the delivery of high-quality, fit-for-purpose, single-use systems with strong documentation packages.

  4. Accelerate The Development Of Your Biotherapeutic Drugs 9/10/2025

    Accelerate biotherapeutic development with a platform that integrates data across CLD, USP, DSP, and analytics, which supports advanced technologies, ensures compliance, and streamlines workflows.

  5. Instrument For Accurate Filter Integrity Testing 3/10/2022

    The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.

  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. Culture Media For Biological Indicators 3/1/2024

    Soybean Casein Digest Broth is the recommended media for use with Biological Indicators. The use of another media may detrimentally affect the outgrowth of spores.

  8. FDA 21 CFR Part 11-Compliant Software 2/28/2023

    Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?

    Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.

  9. 21 CFR Part 11 Compliance Checklist For A Universal Pump 5/7/2024

    This checklist provides a detailed look at the requirements of 21 CFR Part 11 and highlights how the Sterisart® Universal | Gen 4 - Advanced supports your efforts to meet these regulatory demands.

  10. Quality, Compliance, And Regulatory Services For Life Sciences 12/21/2020

    The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.