Summary

Paper-based processes, siloed systems, and manual handoffs slow validation execution, raise risk, and make compliance harder than it needs to be.
ValGenesis Validation Lifecycle Suite connects qualification, cleaning validation, and operational execution in one compliant system, using AI to automate repetitive tasks, reduce delays, and stay audit-ready.

Key Takeaways

•    Digitizes and automates validation steps across qualification, cleaning validation, and operational execution in one connected system.
•    Uses AI to automate repetitive work, reduce delays, and accelerate validation execution across functions.
•    Maintains ALCOA+ data integrity with role-based access, and supports seamless integration across global teams and systems.

Who is this for

•    Validation managers and validation engineers
•    Quality assurance (QA) and compliance leaders
•    CQV teams (facility, utility, and equipment qualification)
•    Cleaning validation specialists
•    Manufacturing operations leaders responsible for execution and records
•    Digital quality / transformation teams implementing connected workflows

Relevant Entities and Links

•    MHRA – Guidance on GxP data integrity (ALCOA+)
•    FDA – Data Integrity and Compliance With Drug CGMP: Questions and Answers
•    FDA – Validation of Cleaning Processes (7/93) inspection guide
•    FDA – Process Validation: General Principles and Practices (PDF)