Regulatory Compliance Solutions

  1. 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.

  2. Composable MES For Pharma 6/30/2025

    The Composable MES for Pharmaceuticals provides a starting point for you to implement a tailored, connected production system with end-to-end traceability and right-the-first-time electronic batch records (eBR).

  3. Enhanced Intelligent Batch Records 5/28/2025

    Aizon Execute V2.1.0 is here — and it’s packed with powerful new capabilities designed to make digital batch execution even more flexible, efficient, and intelligent.

  4. Columns To Optimize Your GC Analysis 6/14/2023

    Optimize Your GC Analysis with Zebron GC Columns

    Zebron GC columns are engineered with quality of analysis in mind to better support scientists' research and regulatory analysis for environmental, food safety, food quality, forensics, pharma, fuels, and specialty chemicals.

  5. Solutions For Modern Labs To Advance Science And Healthcare 10/1/2025

    Discover how collaboration and reliability drive meaningful impact across the healthcare and life sciences industries by empowering innovation from lab to clinic.

  6. The Industrial DataOps Solution For Industry 4.0 1/22/2024

    HighByte Intelligence Hub is a DataOps software solution purpose-built for industrial data. The Intelligence Hub enables manufacturers to securely connect, model, condition, and flow valuable industrial data to and from IT systems without writing or maintaining code. The software is deployed at the Edge to merge real-time, transactional, and time-series data into a single payload for consuming applications.

    With the Intelligence Hub, users can speed system integration time, rapidly leverage contextualized data for analytics, AI, and ML applications, and govern data standards across the enterprise. HighByte Intelligence Hub provides the critical data infrastructure for Pharma 4.0.

  7. Eight Channel Absorbance Readers With Advanced LED Technology 10/24/2025

    Learn about fast, reliable ELISA readings with LED optics, robust data analysis, and automation-ready design that is validated for IVDR and FDA compliance to support efficient lab operations.

  8. 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.

  9. High-Quality Raw Materials For Cell And Gene Therapy Manufacturing 6/7/2024

    Explore growth factors and cytokines for regenerative medicine and cell and gene therapies offered in both GMP and preclinical grades.

  10. Highly Potent And Complex API Contract Manufacturing 4/23/2024

    Equipped with a diverse array of scales, our seasoned experts possess the finesse and acumen necessary to tackle even the most intricate and potent API projects.