Indelio - 2026 Pricing, Features, Reviews & Alternatives

Indelio is an AI-native electronic quality management system designed to provide comprehensive quality management capabilities for medical device and biotechnology organizations. The platform delivers a fully integrated quality system that encompasses controlled documents, corrective and preventive actions, audits, risk management, training, and supplier management in a unified environment. It supports compliance with twenty-one CFR Part eleven and GAMP five and aligns with ISO thirteen thousand four hundred eighty-five. The system incorporates two-component electronic signatures and maintains an immutable hash-chained audit trail to ensure data integrity and regulatory adherence. It is designed for device and biotech teams operating at a scale below enterprise-level solutions and deploys within days with validation included.

The platform comprises twelve interconnected modules that operate as a cohesive quality ecosystem rather than isolated tools. The Document Control module manages the controlled document lifecycle with electronic signature capabilities and controlled PDF generation. The Change Control module provides impact assessment and approval workflows. The Customer Complaints module handles intake, investigation, and medical device reporting decision processes. The CAPA module guides users through root cause analysis, corrective and preventive actions, and effectiveness checks while linking related quality events. Additional modules include Nonconformances for disposition and closure management, Design Controls for design history file maintenance with traceability, verification, and validation activities, and Risk Management aligned with ISO fourteen nine seven one standards for hazard identification, severity and probability assessment, and control measures.

The Training module enforces read-and-understand protocols tied to approved documents. The Supplier Qualification module maintains qualification records and the approved supplier list. The Audits module generates findings that can initiate CAPA records and produces signed audit reports. The Projects and Validation module provides dedicated workspaces for user requirements specifications, installation qualification, operational qualification, and performance qualification documentation. The Management Review module facilitates signed executive reviews of the quality management system. The underlying architecture ensures that actions in one module trigger responses in related modules, such as audit findings opening CAPA records, supplier audits populating supplier files, or document updates flagging retraining requirements.

Artificial intelligence capabilities support drafting standard operating procedures, performing regulatory redlining, and migrating legacy documentation while requiring human oversight through mandatory signatures on all records. The system enforces twenty-one CFR Part eleven compliance at the database level with segregation of duties, role-based access controls with multi-factor authentication, and database-enforced data isolation. Each subscription includes a comprehensive validation package containing the validation plan, system requirements specification, Part eleven traceability matrix, installation and performance qualification protocols, and a suite of automated tests that customers execute against their own instances with vendor support. Security measures protect quality records and ensure appropriate access restrictions across the organization.