Orcanos ALM and QMS is a comprehensive software solution designed to streamline the processes of Application Lifecycle Management (ALM) and Quality Management System (QMS) for organisations, particularly in the medical device and life sciences sectors. With its focus on compliance with regulatory standards, Orcanos integrates tools for project management, risk assessment, document control, and collaboration, ensuring that teams can efficiently manage their product development lifecycle while maintaining quality and compliance.
Core Features
- Integrated ALM and QMS: Seamless integration of application lifecycle management and quality management processes.
- Regulatory Compliance: Built to meet stringent standards such as ISO 13485, FDA 21 CFR Part 820, and other global regulations.
- Document Control: Centralised management of documents, ensuring version control and accessibility for all stakeholders.
- Risk Management: Comprehensive tools for identifying, assessing, and mitigating risks throughout the product lifecycle.
- Traceability: Enhanced traceability features that link requirements, tests, and issues, facilitating easier audits.
- Customisable Workflows: Flexibility to tailor workflows to suit specific organisational processes and requirements.
- Collaboration Tools: Features that support teamwork and communication across departments, improving project outcomes.
Benefits
- Increased Efficiency: Streamlines workflows and reduces redundancies, allowing teams to focus on critical tasks and speed up product delivery.
- Enhanced Compliance: Ensures adherence to industry regulations, significantly reducing the risk of non-compliance penalties.
- Improved Quality: Facilitates a culture of quality assurance, leading to better product outcomes and customer satisfaction.
- Cost-Effective: Reduces costs associated with compliance management and project delays by providing a single platform for all processes.
- Scalability: Suitable for organisations of all sizes, from startups to large enterprises, allowing for growth without the need for significant system changes.