Content Video
ValGenesis PLS™: Process Excellence. From Design to Verification.
[0:19] It's time to modernize process development and verification with a digital platform that ensures quality, compliance, and control from early development to commercial manufacturing.
[0:33] ValGenesis Process Lifecycle Suite is an integrated, cloud-based solution that connects every step of your process lifecycle through QbD-driven structure, real-time data, and intelligent risk assessment.
[0:46] Build robust processes with iCMC, track performance, detect deviations, and generate reports with iCPV.
[0:54] Automate risk assessments using built-in templates and intelligent analytics to prevent issues before they impact quality.
[1:02] The suite ensures ALCOA+ compliance, centralized knowledge, and seamless integration with your LIMS, MES, and ERP systems.
[1:09] ValGenesis Process Lifecycle Suite: your intelligent foundation for risk-based development, proactive deviation control, and sustained product quality.
Summary
Spreadsheets, siloed systems, and reactive risk management slow process development and verification. This video introduces ValGenesis Process Lifecycle Suite, a cloud platform built around QbD structure, real-time data, and risk assessment.
Use Valgenesis iCMC™ to design processes and analytical methods with structured workflows, and Valgenesis iCPV™ to monitor CPPs and CQAs, detect deviations early, and generate reports. The suite supports ALCOA+ compliance and integrates with LIMS, MES, and ERP.
Key takeaways
• Replace spreadsheets and disconnected tools with a cloud platform for process development and verification.
• Use Valgenesis iCMC™ for structured QbD workflows and Valgenesis iCPV™ for real-time monitoring of CPPs and CQAs with automated reporting.
• Support inspection readiness with ALCOA+ data integrity, centralized knowledge, and integration with LIMS, MES, and ERP systems.
Who is this for
• Process development scientists
• CMC leads and managers
• MSAT (Manufacturing Science and Technology) engineers
• Continued process verification (CPV) and process monitoring analysts
• Quality assurance (QA) and quality systems professionals
• Manufacturing engineers and operations leaders
• Analytical development leads
Relevant entities and links
• FDA – Process Validation: General Principles and Practices (Guidance for Industry): https://www.fda.gov/files/drugs/published/Process-Validation--General-Principles-and-Practices.pdf
• ICH Q8(R2) – Pharmaceutical Development: https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf
• ICH Q9(R1) – Quality Risk Management: https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2022_1219.pdf
• ICH Q10 – Pharmaceutical Quality System: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf
• MHRA – Guidance on GxP data integrity (covers ALCOA/ALCOA+ expectations): https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity
