ALM AND QMS

The quality journey for medical device companies is rarely simple. There are likely to be numerous hurdles to clear, many of which can have a bearing on how quickly a product comes to market. More often than not, the product lifecycle needs boxes to be ticked from the moment that an idea is born until the time it becomes a working device in the healthcare sector.

Orcanos integrates Design Control (Application Lifecycle Management), a formalized Quality Management System (QMS) and the keys to Regulatory Compliance in one central access point. End users can also generate data into Microsoft Office tools at any point, and either export them for e-signature in the Orcanos Document Management System or directly sign the electronic records. 

INTEGRATED RISK MANAGEMENT

Understanding and appreciating risk is an inherent part of any product lifecycle. Continuous visibility for stakeholders is key, and identified hazards must be mitigated before a product failure becomes a problem. 

Orcanos audit tools integrate Risk Management into the various stages of product development and QMS processes, generating actionable data with a single click. In fact, our research has shown that companies can save up to 30 percent of the resources allocated to manual risk management by leveraging our ISO 14971 compliant software.

CUSTOMIZED E-FORMS

Paper-based QMS processes can be a bottleneck in the race to get a product to market. Orcanos replaces the traditional method of submitting required documentation with electronic forms, which can have a positive impact on both productivity and efficiency. 

Our solution includes the following upgrades to paper-based quality processes:

• Intuitive customization tools that incorporate simple templates
• Support for a wide variety of field types
• Effective workflow routing for e-signature  (21 CFR Part 11 compliant)
• E-form traceability across the entire process
• Ability to set up logical steps to comply with mandatory rules
• Access control for end user inputs such as Add/Edit/View
• Filters 
• Drag and drop interface, no coding required!

Key Features