Adhere to strict MDR/FDA regulations and ISO quality standards by eliminating paper-based QMS processes.
Orcanos QMS, an introduction …
As healthcare continues to evolve, medical device companies need to ensure that their quality management processes can keep up with the fast pace of digital innovation. Business optimization strategies must now align with the technology available, replacing archaic paper-based systems and spreadsheets with tools that provide a single view of the relevant information.
Orcanos Quality Management System (QMS) is that tool. Our QMS software holds all of the required data points for compliance, controlling all of the quality processes in a single access point. This focused view enables companies to not only eliminate the paper trail in the quality journey but also allows an organization the insights to adhere to strict FDA regulations and established ISO quality standards.
A key to compliance in the digital age is the removal of paper-based quality information and the integration of automated and optimized solutions.
Required reporting elements such as e-DMS, e-DHR, Complaints Management, FMEA Risk Management, CAPA, ECO, Non-Conformities, Engineering for Verification and Validation (which includes Requirements Management, Test Management and Defect Tracking) can be monitored in a single system.
Removing multiple QMS channels means that companies can quickly ensure that products meet regulations and quality standards.
The Orcanos e-QMS platform is both easy to use and includes professional tools that build a centralized QMS within hours, such as:
- Electronic forms with e-Sign capabilities
- Tractability tool
- Support for ISO 13485 and ISO 9001
- Automatic work flows for QMS forms, including but not limited to CAPA and ECO
- A professional dashboard to track and control information
- Compliance AI engine that monitors data in real-time
Document Control Software System
Orcanos e-DMS is an all-in-one document control software system that has been designed to allow end users to create, trace, search, archive and approve all documentation that is related to every stage of a medical device product launch.
The e-DMS ensures that documents relating to the planning, design, development, manufacturing and service of a particular product can be quickly accessed, increasing the effectiveness of quality processes and reducing the time to market.
In addition, Orcanos’ e-DMS supports any document type, including but not limited to user manuals, procedures, required forms, work orders or instructions, product specifications, inspections test protocols and non-conformity reporting.
ISO 14971: Risk Management
An important and critical part of any effective QMS is risk management. In the medical device sector, this falls under the purview of ISO 14971.
The application of good risk management practices is an integral part of the product lifecycle, starting with research and development and continuing through manufacturing and eventual entry into the marketplace. Risk management does not end when a product is sold, which means that post-marketing observation for any quality-related issues such as CAPA or product recalls due to safety concerns must be taken into account.
The ability to identify risks or real-world problems in a product or processes is a key aspect in the quality journey. Without these insights, companies may be unable to mitigate potential risk or ensure compliance. Importantly, a perceived lack of quality by third parties can have a negative impact on the brand itself.
Orcanos Failure Mode & Effects Analysis (FMEA) module for risk management has been designed to provide a complete and accurate picture of the risk landscape. This insight provides the end user with data relating to product lines and business processes, ensuring that companies have an understanding of potential risk from day one.
The module also includes a traceability tool that can integrate any risk to any e-QMS element. Items such as non-conformity, customer complaints or highlighted design flaws can then be subject to risk mitigation, reducing the time spent on analyzing the effects of risk and limiting the chances of potential product failures.
In fact, the Orcanos Medical FMEA software is just one of dozens of modules within the quality control system.
Change Management (ECO)
Another module that forms a vital part of the quality process, Orcanos Engineering Change Order (ECO) management system means that companies can digitally document and control ongoing change processes within the product lifecycle.
Elements such as Standard Operating Procedures (SOPs) and design specs, for example, can be monitored for pain points, thereby enhancing a company’s productivity levels
Customer complaints are an unwelcome part of the quality process, being able to effectively manage and solve them in a reasonable time frame is critical. Complaint management can also limit the chances of product recall and damage to brand reputation, two factors that can have a significant financial impact on current and future business opportunities.
Orcanos Complaint Management System alleviates these concerns and ensures that companies can continue on their path. The software supports the ISO 13485 post surveillance procedure, with a focus on complaint handling and labeling control
One of the more well-known requirements of the quality management process, CAPA (Corrective and Preventive Actions) is another potential pain point for the unprepared. Medical device companies that don’t eliminate non-conformities or undesirable situations in their products run the risk of these problems recurring both now and in the future.
Orcanos CAPA software not only improves the chances of finding an issue before it becomes a problem, but also automates the CAPA process completely. Routing and notifications, for example, can be integrated and identifying deviations in product quality or events can be caught early.
This module means that companies can be confident that all phases of CAPA are supported, from the time of initiation to investigation closure.