Quality Assurance

INSIGHTS ON QUALITY ASSURANCE

How Asia and Europe Are Reshaping Biologics Manufacturing
As biologics manufacturing globalizes, companies must balance cost, capacity, risk, and control when choosing between European and Asian supply bases for clinical and commercial success.
Forge Boosts Efficiency And Compliance During External Collaboration
Streamlined collaboration and unified quality systems are helping CDMOs cut review times. Discover how connected workflows improve compliance and efficiency for faster delivery of life-changing treatments.
NGS In GMP Manufacturing: Reducing Risk, Increasing Return
Global regulators now recognize NGS as a rigorous, GMP‑ready tool for viral safety, driving a shift toward scalable quality strategies. Learn why NGS is becoming central to modern manufacturing.
Master The 2-Point Calibration Process To Maintain Data Integrity
Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.

What The FDA's AI Device Software Guidance Signals For Your Traceability
7/13/2026

FDA draft guidance sets lifecycle expectations for AI/ML medical device software. Review dataset provenance and post-market monitoring strategies to prepare your submissions.
Determining The Limit Of Detection In CCIT
12/18/2025

Accurately determining the smallest detectable defect in pharmaceutical packaging is essential for sterility. Learn how test sensitivity, positive controls, and regulatory standards shape CCI strategies.
Biotech Firm Streamlines Maintenance, Calibration & Validation With RAM
8/8/2025

Explore how a U.S. biotech company uses RAM to centralize maintenance, calibration, and validation to improve compliance, efficiency, and visibility across multiple facilities.
6 Things To Consider During Visual Inspection Operations
7/14/2025

Even with automation, manual visual inspection remains vital in sterile drug manufacturing. Discover six advanced considerations for refining your operations, ensuring compliance, and minimizing costs.
Prevent Batch Failures Before They Happen
6/11/2025

Discover a platform that reduces operator errors and batch failures through automation, real-time monitoring, and intelligent design to ensure greater process reliability and consistent outcomes in your workflow.

Raw Materials For Biopharmaceutical Manufacturing

Reliable production depends on material quality, process fit, and regulatory confidence. Get a practical look at solutions and support across upstream, downstream, and formulation workflows.
Inhalation Products: Technology And Know-How

Move from product concept to validated production with coordinated support across process development, technical implementation, cleanroom testing, approval, startup, and long-term optimization, helping maintain reliability from early laboratory work through commercial manufacturing.
Manage, Analyze, And Visualize Sequencing Data

Simplify NGS workflows with a platform that automates analysis, integrates diverse data types, and supports GMP validation to extract meaningful insights and streamline regulatory documentation.
Proven Product Inspection Solutions

Gain a clear overview of inspection technologies that help reduce contamination risks, verify packaging integrity, and strengthen compliance across diverse manufacturing environments.
Drug Product Fill Finish And Formulation Solutions

Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.