Digital Brochure - PLS
Digitalize, optimize, and ensure product quality through risk-based process lifecycle management
See how the suite supports process development, scale-up, tech transfer, and continued monitoring so you stay inspection-ready from early development through commercial manufacturing.
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What’s in it
This brochure explains how ValGenesis Process Lifecycle Suite supports end-to-end process development across the lifecycle, using QbD-driven workflows to move from early design to commercial manufacturing. It outlines centralized, science-based risk assessments for better traceability and early risk control, plus real-time monitoring of CMAs, CPPs, and CQAs with automated alerts and visualizations through Valgenesis iCPV™.
You’ll also see how Valgenesis iCMC™ supports process and method development structure and analytics, along with options to generate regulatory-ready reports using customizable templates, scheduled updates, and automated version control. The brochure also covers built-in compliance features for global regulatory expectations, audit-ready workflows, and ALCOA+ data integrity, as well as integration with systems such as LIMS, MES, ERP, SAP, and QMS, and secure scaling with cloud-native access controls and encrypted data.
Who this is for
- MSAT leaders and process scientists responsible for process development, scale-up, and tech transfer
- Continued process verification (CPV) owners managing CPP/CQA monitoring and trending
- Quality assurance and quality systems leaders focused on inspection readiness and data integrity
- Regulatory affairs and compliance professionals supporting audit readiness and global alignment
- Manufacturing and technical operations leaders accountable for ongoing process control and performance
- IT, digital manufacturing, and systems integration teams connecting LIMS, MES, ERP/SAP, and QMS
What it helps with
- Streamlines process development with QbD-driven workflows from early design through commercial manufacturing
- Reduces risk and improves traceability with centralized data and science-based risk assessments
- Monitors CMAs, CPPs, and CQAs in real time using automated alerts and visualizations (Valgenesis iCPV™)
- Supports process and method development structure and analytics (Valgenesis iCMC™)
- Produces regulatory-ready reports with templates, scheduled updates, and automated version control
- Connects with LIMS, MES, ERP/SAP, and QMS for real-time data sharing across systems
- Maintains audit-ready workflows and ALCOA+ data integrity to support global compliance
- Scales securely with cloud-native architecture, access controls, and encrypted data
Customer Testimonials
We work with ValGenesis iCMC to digitalize our QbD framework within GSK for the development of new vaccines. We are confident that iCMC will be key for simplification, acceleration, and knowledge management.
Hervé Gressard
Head of Global Project Statistics CMC Technical R&D
Implementing ValGenesis iCPV has transformed our approach to CPV. The integration of our data systems and the comprehensive training from the ValGenesis team have empowered our users, ensuring we meet regulatory standards while enhancing efficiency and data integrity.
Patricia Watanabe
Validation Supervisor