Content Video
ValGenesis iVal™: Faster Validation. Smarter Execution. Always Audit-Ready.
0:11 Manual validation slows you down and adds risk.
0:14 It’s time for a more innovative, faster way to validate and accelerate speed to market with intelligent automation and connected data.
0:24 ValGenesis iVal is an AI-assisted validation lifecycle management system that automates validation processes, accelerates execution, and ensures compliance — all in one place.
0:35 It supports Agile CSV and CSA, delivers comprehensive CQV, and leverages AI to reduce cycle times by up to 80%.
0:44 From intelligent document generation to anomaly detection, iVal reduces manual effort and improves validation quality.
0:51 And when it comes to compliance, iVal ensures audit readiness with real-time traceability and secure access control.
0:59 ValGenesis iVal — AI-powered validation to ensure compliance, optimize resources, and accelerate your speed to market.
Summary
Manual validation slows teams down and adds risk. Valgenesis iVal™ replaces this with an AI-assisted validation lifecycle management system that brings automation and connected data into one place.
It supports Agile CSV and CSA, delivers comprehensive CQV, and uses AI to cut cycle times by up to 80%. Features like intelligent document generation, anomaly detection, real-time traceability, and secure access control help keep you audit-ready.
Key takeaways
• Replace manual validation work with AI-assisted workflows and connected data in one system.
• Support Agile CSV and CSA while delivering comprehensive CQV and reducing cycle times by up to 80%.
• Stay audit-ready with real-time traceability and secure access control, plus features like anomaly detection and intelligent document generation.
Who is this for
• Validation managers and qualification engineers (CQV/CSV/CSA)
• Quality assurance and compliance leaders preparing for audits
• Computer system validation and assurance specialists adopting CSA
• Manufacturing and operations teams executing and approving validation documentation
• Engineering and automation teams managing equipment and system validation activities
• Regulatory affairs professionals supporting inspection readiness and evidence packages
Relevant entities and links
• FDA draft guidance: Computer Software Assurance for Production and Quality System Software: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software
• 21 CFR Part 11: Electronic Records; Electronic Signatures (eCFR): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
• EU GMP Annex 11: Computerised Systems (European Commission PDF): https://health.ec.europa.eu/system/files/2016-11/annex11_01-2011_en_0.pdf
• MHRA GxP data integrity guidance (UK Government PDF): https://assets.publishing.service.gov.uk/media/5aa2b9ede5274a3e391e37f3/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf
• PIC/S: Guidance on Data Integrity: https://picscheme.org/docview/4234
