Content Video
ValGenesis iCPV™: Proactive Monitoring. Real-Time Insights. Quality Assured.
[0:19] It's time to move beyond manual CPV report preparation and fragmented data management.
[0:25] With a real-time intelligent system built for continuous monitoring, guided workflows, and centralized process control, ValGenesis iCPV monitors CPPs and CQAs across manufacturing lines, automatically detecting trends, generating reports, and reducing process deviations before they escalate.
[0:44] From guided CPV program design to automated statistical analysis, iCPV simplifies reporting, supports compliance, and drives proactive process control.
[0:54] ValGenesis iCPV, your intelligent system for streamlined, audit-ready, and always-on process verification.
[1:01] It detects deviations early and keeps processes under control.
Summary
Manual CPV reporting can be slow and error-prone when data is disconnected and reports are built by hand. This video shows a shift from spreadsheets to a real-time dashboard for continued process verification.
ValGenesis iCPV monitors CPPs and CQAs across manufacturing lines, detects trends early, and automates reporting. Guided program setup and automated statistical analysis help teams keep processes under control and stay audit-ready.
Key takeaways
• Replace manual CPV report prep and fragmented data with real-time monitoring and guided workflows.
• Monitor CPPs and CQAs across manufacturing lines to detect trends early and reduce deviations before they escalate.
• Automate statistical analysis and reporting to support compliance and keep CPV outputs audit-ready.
Who is this for
• Process validation and CPV engineers
• Manufacturing science and technology (MSAT) teams
• Quality assurance and compliance leads
• Manufacturing/operations managers overseeing process performance
• Data analytics or statistical process control specialists
• Tech transfer and lifecycle management teams
• Digital quality and data integrity professionals
Relevant entities and links
• FDA – Process Validation: General Principles and Practices (Stage 3 CPV) – https://www.fda.gov/media/71021/download
• eCFR – 21 CFR Part 11 (Electronic Records; Electronic Signatures) – https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
• eCFR – 21 CFR Parts 210 and 211 (cGMP for drugs) – https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210
• EudraLex Volume 4 – Annex 11 (Computerised Systems) – https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
• EMA (European Medicines Agency) – https://www.ema.europa.eu/en
• MHRA – GxP Data Integrity Guidance (ALCOA/ALCOA+ concepts) – https://www.gov.uk/government/publications/gxp-data-integrity-guidance-and-definitions
• ISPE – GAMP (Good Automated Manufacturing Practice) – https://ispe.org/gamp
• Westgard Rules (statistical rules used in monitoring) – https://www.westgard.com/westgard-rules.htm
