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Orcanos

by Orcanos · Since 2015
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ActiveAvailable globally
Quick facts
VendorOrcanos
Year launched2015
StatusActive
LocationOrcanos Ltd. Ariel Sharon 4 A, Ha’Shachar Tower Givatayim Israel
Countries servedGlobal
Languages1
Integrations10+
Free tierN/A
Free trialN/A
Contact salesN/A

About Orcanos

Orcanos is a quality management software from Orcanos that supports the development of complex products in regulated industries. It provides document management, requirements management, and risk management so teams can maintain compliance with industry standards. With Orcanos, users can simplify project documentation and ensure traceability throughout the product lifecycle. The software facilitates collaboration among team members by allowing for real-time updates and access to important documentation. Key capabilities: document management requirements management risk management compliance tracking project collaboration Best for: organizations in regulated sectors that need to manage quality and compliance efficiently.

Orcanos Quality Management Software offers a comprehensive solution designed specifically for the regulatory compliance needs of industries such as medical devices, pharmaceuticals, automotive, and aerospace manufacturing. Founded in 2015 and headquartered in Givatyim, Israel, Orcanos has quickly established itself as a vital player in the field of software development for quality management systems (QMS) and application lifecycle management (ALM). With a focus on automating design control and quality management processes, Orcanos helps organizations transition from cumbersome paper-based systems to streamlined, digital solutions. The primary strength of Orcanos lies in its ability to address the challenges faced by manufacturers dealing with manual traceability management. Many organizations find themselves hindered by traditional quality systems that can lead to inefficiencies and increased risk. Orcanos effectively mitigates these issues by providing a single platform that integrates multiple functions necessary for regulatory compliance, such as document control, risk management, and audit management.

Pros & Cons

Pros
  • Comprehensive QMS functionality.
  • Strong focus on regulatory compliance (ISO 13485, FDA).
  • User-friendly interface with powerful customization options.
  • Integrated risk and document management
Cons
  • Pricing may not be transparent without direct inquiry.
  • Some users report a learning curve associated with more advanced features

Features

Key features

Document Control

Automates compliance processes and document routing.

Risk Management

Integrates ISO 14971 risk management throughout the lifecycle.

Change Management

Streamlines the release of new document revisions.

Complaints Handling

Manages complaint investigations and resolutions.

CAPA Management

Ensures compliance with corrective and preventive action procedures.

Audit Management

Prepares users for audits with thorough documentation.

Training Management

Facilitates employee training tracking and compliance.

Integrated Dashboards

Provides analytics and project tracking through customizable dashboards

Additional features

Document Control

Automates the management and approval of quality documents to ensure compliance and efficiency.

Risk Management

Integrates risk assessment practices to adhere to ISO 14971, enhancing safety and compliance throughout the product lifecycle.

Change Management

Streamlines the process of managing changes in documentation and procedures, enabling quick revisions and updates.

Complaints Handling

Provides a systematic approach to manage customer complaints, from investigation to resolution, improving customer satisfaction.

CAPA Management

Facilitates corrective and preventive actions to address non-conformances and maintain quality standards.

Audit Management

Prepares organizations for audits by managing documentation and providing tools for internal and external audits.

Training Management

Tracks employee training requirements and compliance, ensuring staff are qualified and knowledgeable.

Supplier Qualification

Manages supplier information, performance, and compliance to ensure quality across the supply chain.

Nonconformance Management

Simplifies the identification and resolution of non-conformance issues, helping to maintain product quality.

Customizable Workflows

Allows users to tailor workflows to meet specific quality processes and company procedures.

Electronic Signature Compliance

Supports compliance with 21 CFR Part 11 for electronic records and signatures, ensuring regulatory adherence.

Analytics and Reporting

Provides customizable dashboards and reports for tracking performance and quality metrics.

Integrated ALM (Application Lifecycle Management)

Combines quality management with lifecycle management for a comprehensive view of product development

Pricing

Free trial
Free version
Request a quote
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Countries & Languages

Global
Countries served
1
Interface languages
18
Billing currencies

Interface languages

English

Billing currencies

🇺🇸USD🇪🇺EUR🇬🇧GBP🇦🇺AUD🇨🇦CAD🇯🇵JPY🇨🇭CHF🇨🇳CNY🇭🇰HKD🇸🇪SEK🇸🇬SGD🇮🇳INR🇧🇷BRL🇿🇦ZAR🇦🇪AED🇲🇽MXN🇳🇿NZD🇰🇷KRW

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