Enhance efficiency for robustness and effectiveness of validation using risk-base platform, from validation concept to documentation, validation execution, storage, approval, to audit correspondence, ensuring in one platform.
ValGenesis Lifecycle Suite
Validation Lifecycle Management System The system incorporates various regulations and risk-based approaches from validation concept stage to audits and disposal, and supports the creation of various documents such as URS, CSV, CQV using Yes/No charts. Requirements, URS, SOP can be accessed and viewed with hyperlinks, ensuring accuracy and time saving.
Electronic Execution
Regardless of whether online or offline, various CQVs can be excuted using terminals appropriate to the site using CQV documents created by VLMS.
Import and upload data from cameras and measuring instruments directly to CQV documents, and finally submit to users or approvers, and seamlessly combine electronically until approval.
Rapid Audit Response
When validating a wide range of manufacturing processes, paper-based validation audits are extremely difficult.
Preparing documents, coordinating with related departments, linking various documents, and responding to audits based on related standards, laws, and requirements was also a burden.
With VLMS, you can access related documents and records not only from the document flow, but also from the hyperlinks of individual documents, and you can print documents requested by the auditor, significantly reducing the time required for audit preparation.
Centralized Management of Service Vendors' CQV
CQV outsourcing management can also be done with VLMS.
Say goodbye to the wide variety of document formats provided by each vendor.
Grant VLMS accounts and permissions to vendors to seamlessly connect document exchanges between users and vendors.
Use hyperlink to instantly check URS, other related documents, and facilities.
Comprehensive Application
iVal
Supercharge validation with ValGenesis iVal™. AI-powered authoring, automated execution, live anomaly flags, and bulletproof traceability slash cycles by up to 80% and cut observations by 90%. From CQV to CSA, you’ll be audit-ready and market-ready faster than ever. iVal takes digital validation to the next level.
iClean
Halve cleaning validation timelines and wipe out manual math with ValGenesis iClean™. Automated MACO calculations, ADE-aligned limits, 2D/3D equipment maps, and rule-driven workflows deliver digital, inspection-ready files across all sites. Standardize globally, flex locally, and gain real-time oversight - discover iClean today.
iOps
Leave paper logbooks behind with ValGenesis iOps™. Mobile, QR-enabled forms capture every use, cleaning, and calibration event in real time; automated reviews, deviations, and alerts seal compliance gaps. Achieve 100% traceability, trim documentation labor by 70%, and connect ops to quality with iOps today.