Our Process The Orion Process has been refined from our experience in clinical diagnostics and consumer health care, developing products requiring FDA 510K submissions and requiring a validated development process.  Because the Orion Process is practical and effective, we apply this same method to advantage on all projects we undertake, regardless of the industry or the application. The result is a predictable process with reliable outcomes that can be measured and continuously improved. The Orion Process is both agile and validated, allowing work to proceed un-encumbered, while maintaining a completely validated and traceable effort. We also offer a web-accessible quality management tracking system to keep clients appraised of open issues for advanced development projects.

While the Orion Process is not yet available to the general public, we offer here a partial list of our manuals and Standard Operating Procedures (SOPs) maintained as the rubicon of our Quality System - and serving as the blueprint of our development process: Document Description Quality Manual Quality system manual and overview of quality system Quality Meeting Record Standard templates for meeting records and minutes Quality Organization Roles Roles and responsibilities Quality Statement Corporate quality statement Quality System Documentation Matrix Quality system documentation matrix SOP Defect Tracking Standard procedures for defect tracking SOP for Document Retention Standard procedures for documentation mantainence SOP for HIPAA Standard procedures for HIPAA compliance SOP for Personal Conduct Standard procedures for personal conduct and behavior of employees and contractors SOP for System Backup Standard procedures for system backup and recovery plus contingency plans SOP for System Privacy Standard procedures for system privacy (HIPAA) SOP for System Review Standard procedures for system review and audit SOP for System Security Standard procedures for system security (HIPAA) SOP for System Testing Standard procedures for system testing for products and client projects SOP for Software Code Inspections Standard procedures for peer code inspections/review SOP for Software Coding Standard procedures for coding guidelines and standards SOP for Software Design Reviews Standard procedures for peer software design reviews SOP for Software Development SOP Software Labeling Standard procedures for software product labeling ... ... While the Orion Process benefits any development effort, it obviously leverages our understanding of the healthcare industry to follow methodologies that are sensitive to HIPAA and FDA requirements.  Our technical team is trained in the regulatory issues surrounding IT development and documentation, and we maintain thorough Standard Operating Procedures (SOP) for software development.  In addition to improving overall quality and efficiency, our SOPs are structured to support FDA regulatory guidelines, including full traceability.