COMPLIANCE
MANAGEMENT

Risk Management

Audit-Ready

Post Marketing Surveillance

Complaince management
Compliance Based-ALMAdaptive QMS

Compliance Based-ALM

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Compliance Requirements Management

Requirements Management

Manage all product requirements from various aspects in one place, supporting two points of view - compliance and development.
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Orcanos Requirements Management Tool simplifies any process related to requirements tracking. Flexible and powerful enough for both enterprise-size organizations and SMBs, the Design Input (DI) and Design Output (DO) tool has what you need to save time and costs within the process. Automated features make it easier to meet compliance requirements and save “bureaucracy time” that keeps the developer focused on developing.

Features
  • End-to-end traceability, such as requirements to risk items for mitigation and link requirements to test cases for verification and validation
  • Change impact analysis
  • Audit trail and electronic signature according to the 21 CFR part 11
  • One-click Document generator to export your DHF to ready-to-submit MS-Office files
  • Use baselines and branches to manage your product releases better and track version changes and support an effective sequential or parallel development.
  • Enable real-time collaboration between teams, such as product managers, developers, Engineers, QA Members, etc.
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Test Management

Assure any validation and verification in any phase.
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Orcanos brings lifecycle compliance vision to every part of the SDLC process. Plan and execute test cases, record, and report the results, and track defects using the integrated bug tracking tool. It is tightly integrated into compliance management.
Using Orcanos assures full traceability in one single repository. All test executions result can be viewed in informative dashboards, making it easy to manage and put decisions and efforts into the right place.

Features
  • Assure a complete test coverage of requirements
  • Eeaily pln. organize and execute test cases.
  • Simply integrate into any automation environment
  • Ability to generate reports such as test design and test results ready for submission
  • Use test management parameters as a powerful tool for managing complex test environments and multiple configurations.
  • Automate the defect reporting from a test run until fix and validation in one streamlined process to shorten resolution time
Compliance Management Features
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