INSIGHTS ON QUALITY ASSURANCE

QUALITY ASSURANCE SOLUTIONS

  • LIGHTHOUSE’s FMS-Water Activity Analyzer measures the water activity (% RH) of drug product samples.

  • 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.

  • Finding a strategic CDMO partner that will offer tailored solutions for your late phase clinical and commercial needs, mitigate risks, and bolster your supply chain is crucial for meeting project milestones on time.

  • Proactively manage risks of pharmaceuticals, medical devices and other products with TrackWise Digital. The built-in templates comply with ISO 14971 and ICH Q9 allowing manufacturers to manage risks throughout the entire product lifecycle directly within TrackWise Digital.

  • West is a leading global manufacturer in the design and production of technologically advanced, high quality, integrated containment and delivery systems for injectable medicines. We are a trusted partner to the world’s top pharmaceutical and biotechnology companies—working by their side to improve patient health.