Government

PRODUCTS

  • Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation

    SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.

  • ProPharma has deep expertise across all signal detection and management activities, including validation, prioritization, and assessment using data from a wide range of sources that are relevant for signal detection for the individual product(s). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.

  • With our global network of facilities and services, Cryoport Systems is a strategic partner of choice for temperature-controlled supply chain management of critical materials.

  • Legacy paper trails are a compliance nightmare.

    Missing documents, illegible handwriting, and inconsistent data leave you scrambling and vulnerable during audits. Digital CQV captures data and objective evidence in real time, ensuring a crystal-clear audit trail with time-stamped entries and electronic signatures that meet 21 CFR Part 11 requirements.

  • TrialKit requires minimal training for quick deployment. Its open API integrates seamlessly with databases, ideal for fast patient registry studies and high-quality data.

WHITE PAPERS AND CASE STUDIES

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