Quality Assurance

INSIGHTS ON QUALITY ASSURANCE

Preparing Global Parenteral Sites For Annex 1 Compliance
Modern sterile manufacturing requires proactive quality risk management. Robust contamination control across facilities, processes, and supply chains supports compliance and patient safety.
Navigating GxP Compliance Challenges
Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.
Cambrex Scientist Spotlight: Elena Bejan
Holding a Ph.D. in organic chemistry from Paris-Sud University and an MBA from the Rotman School of Management, Bejan leads R&D efforts at Cambrex with a focus on scientific innovation.
A Decision Focused Guide To Contamination Control From Design To Opening
Stop treating contamination control as a late-stage detail. Learn how making early, intentional design choices prevents startup delays and ensures your new cleanroom is ready for inspection.

Manufacturing Made More Robust And Customer-Centric
12/11/2025

Discover how regional manufacturing, risk-aware practices, and agile strategies are reshaping supply chains to deliver resilience, transparency, and sustainability in today’s complex global environment.
Top 3 Things To Consider When Designing A Risk-Based Cleaning Validation Process
10/23/2024

Learn how implementing a systematic approach to cleaning validation can significantly enhance compliance and improve your audit readiness.
Selecting A CDMO For Custom Activated PEGs
1/27/2026

Custom-activated PEGs require thoughtful planning and precise analytical control. Discover key considerations for selecting a partner capable of supporting scalable, compliant PEGylation.
Automating Mass Spectrometry Analysis To Accelerate Oligonucleotide Drug Development
1/29/2026

Oligonucleotide therapeutics demand precise and efficient analytical workflows. Explore how automated data processing offers a faster path to understanding metabolites and advancing development.
A Simple Method For Cell Growth Media Preparation
11/3/2025

Explore how powder media and sterile fluid handling can reduce contamination risk and improve efficiency in viral vector production, especially for HEK293-based AAV workflows.

The Business Case For Electronic GxP Management

Spreadsheet-based quality systems carry costs that tend to be underestimated. Electronic GxP management shifts effort from routine compliance tasks toward quality improvement and patient safety.
Transform GMP Data Into Actionable Intelligence

Explore a system that delivers real-time, compliance-ready analytics, which empowers teams with self-service dashboards, embedded reporting, and actionable calibration and maintenance data.
847 Continuum Program: Trusted Replacement Parts And Dedicated Service Solutions

Maximize equipment uptime through a global support network featuring 24/7 technical assistance, genuine replacement parts, and flexible training programs designed to maintain high performance and ensure operational reliability.
Composable MES For Pharma

The Composable MES for Pharmaceuticals provides a starting point for you to implement a tailored, connected production system with end-to-end traceability and right-the-first-time electronic batch records (eBR).
End-To-End Digital Validation

Learn how AI‑driven validation workflows, automated traceability, and customizable risk frameworks can cut effort dramatically while improving accuracy across complex pharma and biotech operations.