Records Management

PRODUCTS

  • Track and manage defects and non-conformances – such as SOP deviations or missing data – from identification to resolution.

  • Standalone, turnkey, process ready cGMP modular cleanrooms

    Germfree cGMP modular cleanrooms are a platform solution that unlock standalone manufacturing capacity for a variety of applications. Serving processes from cell therapy to sterile fill-finish manufacturing cGMP modular facilities offer unmatched finishes, layout flexibility, controls, timeline assurance, and cost benefits for the biopharmaceutical industry. This is why Germfree has been chosen by 12 of the top 20 biopharmaceutical companies as their modular cleanroom providers.

    Modular cleanrooms highlights: Biopharma, International building codes, IBC, NFPA, ISO. BSL-2 BMBL, FDA, EMA, cGMP compliant

    Applications: Aseptic Filling, Cell Therapy, Gene Therapy, Viral Vector, Plasmids

  • Enforce standardized workflows while collecting data in real time, giving you the visibility you need to prevent deviations, review exceptions, and release batches faster.

  • Neither traditional nor hybrid clinical trials can operate on rigid EDC systems.

    They require flexible data collection systems that support protocol amendments without downtime and accept mobile data without hassle. As a cloud-native solution, TrialKit bends to accommodate mid-study changes. And as the first full-featured EDC platform available as a native mobile app, TrialKit flexes to meet the demands of traditional, hybrid/decentralized, and completely remote clinical trials.

    Give your team the freedom to build, deploy, and manage their studies, their way—weeks faster than with rigid EDCs and for a fraction of the cost of the major players.

  • A global team of trusted experts for multi-phase clinical development.

WHITE PAPERS AND CASE STUDIES

NEWS