QUALITY ASSURANCE SOLUTIONS

• Quality, Compliance, And Regulatory Services For Life Sciences

  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.

• Should You Digitalize Your CQV Process?

  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.

• Pharmaceutical Water Activity Analyzer: FMS Brochure

  The FMS-Water Activity Analyzer is a non-destructive gas analyzer for making water activity measurements of solid dosage drug product samples.

• Enterprise Calibration Management

  Optimize calibration processes with a paperless, enterprise-ready platform to ensure compliance, improve accuracy, and boost efficiency with automated workflows and KPI insights.

• Build A Skilled Workforce With Operator Training Programs

  Human error is the leading cause of poor outcomes after equipment failure in biopharma. Learn how self-paced training, 3D models, and VR simulations can boost operator confidence and process reliability.

• The Next Generation Of The Number One Enterprise Quality Management System (QMS)
• Compliant Storage For Chemicals, Process Liquids, And Buffers
• Small-Scale GMP Manufacturing With ÄKTA Ready™ Chromatography 450 System
• Two Decades Of Sterile Manufacturing Excellence