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iOps

Digital logbook management for equipment operations, cleaning, calibration, and maintenance with real-time data capture and automated compliance workflows.

Solution by ValGenesis
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Overview

ValGenesis iOps™ is a digital operational execution platform designed for life sciences organizations seeking to replace paper-based logbooks with real-time, traceable digital records. Part of the ValGenesis Validation Lifecycle Suite, iOps digitalizes routine activities such as equipment use, cleaning, calibration, maintenance, and quality checks—capturing critical data with full accuracy, consistency, and GxP compliance. It is purpose-built for pharmaceutical and life sciences operations teams that need SOP-driven workflows, robust audit trails, and seamless integration with enterprise systems.

ValGenesis iOps™ delivers measurable impact, including 100% traceability for equipment lifecycle activities—covering cleaning, calibration, and use—alongside a 70% reduction in effort spent on logbook documentation and reconciliation.

Core Capabilities

  • Replaces paper logbooks with real-time digital forms accessible on any device, including mobile
  • Supports QR code and barcode-based form selection to streamline equipment interaction and log form execution
  • Enables offline data capture through a dedicated mobile app, allowing execution in areas without a secure internet connection
  • Provides no-code configuration to align digital forms with existing SOPs
  • Automates scheduling for recurring tasks to drive consistent execution of operational activities
  • Generates QR codes for equipment and associated log forms to facilitate efficient execution

Compliance and Traceability Features

  • Role-based access controls ensure that only authorized personnel interact with relevant forms and data
  • Timestamped audit trails capture every equipment interaction with digital precision, eliminating documentation gaps
  • Automated alerts and deviation notifications enable proactive compliance management, preventing lapses before they occur
  • Configurable execution, verification, and approval workflows governed by business rules to enforce consistency and regulatory compliance
  • Business rules automate decision-making, manage data capture, handle scheduling, and define dependencies between log forms

Workflow and Integration

  • Automated review workflows reduce manual reconciliation effort and accelerate operational oversight
  • Links equipment usage data to enterprise systems including MES, QMS, LIMS, and CMMS for holistic asset readiness visibility
  • Connects operational data with calibration tools to ensure end-to-end quality oversight
  • Integrates seamlessly within the broader ValGenesis Validation Lifecycle Suite for unified lifecycle management

ValGenesis iOps™ is deployable via mobile app for field and cleanroom environments, supporting both connected and offline scenarios. Its integration with widely used enterprise platforms—MES, QMS, LIMS, and CMMS—makes it suitable for organizations seeking enterprise-wide visibility and control over GxP activities and equipment lifecycle management.

Meta

Domain
Manufacturing & Bioprocessing
Subdomain
Validation & GxP Compliance
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechMedical Devices
Development stage(s)
Manufacturing
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsAutomation Engineer
Compliance standard(s)
21 CFR Part 11GxP