ONES vs Orcanos

ONES combines project management and knowledge management in one platform, available on web, API, and self-hosted environments. ONES Project covers requirements and issue management, sprints, progress tracking, test management, resource management, automation, and program management. ONES Wiki provides documentation spaces and pages with permissions, search, and team collaboration. ONES Assistant connects Project and Wiki; it can generate reports, break requirements into tasks, summarize notifications, and answer questions using selected Wiki pages. Code Integration supports GitHub, GitLab, private GitLab, SVN, and private Bitbucket repositories. A Slack integration links accounts and can send notifications about followed issues and selected activity. ONES describes SAML 2.0 single sign-on, login MFA, and audit logs, and says its cloud service meets SOC 2 Type II criteria and adheres to ISO 27018 and ISO 27001. Data can be hosted in AWS data centers in North America, Japan, and Southeast Asia, or on private servers. The free plan is free forever for up to 30 seats. Standard costs $80.50 a year, billed annually; a 30-day trial supports up to 20 users.

Orcanos combines quality management and application lifecycle management for medical device R&D and Quality teams. Its ALM tools cover requirements and design controls, ISO 14971 risk management, testing, traceability, and defect tracking linked to the design history file. The eQMS module handles document control, CAPA and complaints, audits, suppliers, and training. It also lists approval workflows, nonconformance tracking, and compliance records. Ask Paul provides AI-assisted requirement writing, risk-gap detection, audit summaries, regulatory-change monitoring, and natural-language traceability queries. Orcanos describes workflows supporting ISO 13485, EU MDR, FDA 21 CFR Part 11, and ISO 14971. Integrations include GitHub, Jira, and Azure DevOps. The cloud service uses AWS and lists HTTPS transfer, role-based access, IP restrictions, SAML/SSO, ISO 27001:2022 certification, and scheduled backups. Plans range from Starter limits to Professional API access and custom processes; pricing is on request.