Streamline validation, empower compliance, and maximize CAPEX value

What's in it

This datasheet gives an overview of Valgenesis iVal™ and its core benefits, including moving from paper to digital workflows, integrated risk assessment, always-on audit trails, and AI-enabled automation that can reduce validation cycle times by up to 80%.

It also lists the main product features, such as centralized document control, configurable templates and workflows, risk-based CSV/CSA support, offline execution with sync, anomaly detection, dashboards and reporting, and change control integration.

You will find integration notes (LIMS, MES, ERP, QMS), scalability details (multisite, cloud compatibility, configurable workflows), and technical specifications covering deployment options (cloud or on-premises), standards and regulatory support (21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+), and quality/security certifications (ISO 9001:2015 and ISO 27001:2013).

Who this is for

• Validation and CQV teams responsible for qualification and validation execution
• CSV/CSA teams and IT quality teams managing computerized system assurance and evidence
• Quality assurance leaders and quality systems managers focused on inspection readiness and traceability
• Engineering and facilities teams delivering CAPEX projects and equipment qualification
• Manufacturing and operations leaders accountable for throughput, downtime, and compliant execution
• Regulatory/compliance stakeholders who review Part 11, Annex 11, and data integrity controls
• Project/program managers coordinating cross-team validation timelines and deliverables

What it helps with

• Speeds initial evaluation by putting benefits, features, and technical specs in one short document
• Supports internal buy-in by summarizing cycle-time and manual-effort reduction claims in a shareable format
• Makes IT and QA review easier with clear notes on integrations, audit trails, e-signatures, and security controls
• Helps procurement and vendor assessment by outlining deployment options (cloud vs on-prem) and certifications
• Preps teams for a more focused demo by clarifying what to ask about workflows, offline execution, dashboards, and change control links