Health Care

Seapine solutions enable healthcare organizations to enforce process, provide complete traceability, and effortlessly document compliance.

Healthcare organizations are under more pressure than ever before with constant challenges from competition, government scrutiny over regulations, adherence to Current Good Manufacturing Practices (CGMP), and productivity and quality issues. The U.S. government has increased the number of FDA investigators, which in turn has increased the probability of an organization being inspected.To become a competitive, established company in these sectors businesses can insulate themselves from possible detrimental outcomes by reducing overall costs, streamlining research and development, increasing employee accountability, driving process traceability, and accelerating time to market.

Seapine solutions enable organizations to document compliance with industry standards and regulations, and provide traceability from the initial documentation of requirements through test cases, test runs, and issue management. Integrated tools make it easy to automate and enforce workflow processes, and establish clear traceability and ownership while providing process repeatability. Seapine solutions are configurable to meet or exceed FDA regulations for 21 CFR Part 11, Part 210, Part 211, ISO 14971, and CGMP, in addition to helping meet 21 CFR Part 820 compliance and completing GxP assessments.

Seapine's comprehensive and flexible solutions offer:

• Requirements management, impact analysis, and traceability
• Centralized, secure data storage
• Task and issue management
• Audit logging and electronic signatures
• Role-based security
• Process automation and validation
• Asset management and preventative maintenance
• Quality metrics and reporting for management
• Improved quality control

Resources

White papers and case studies:

• Case Study: First Choice Health
• Leveraging 21 CFR Part 11 Compliance to Achieve Broader Product/Process Quality
• Impact of 21 CFR Part 11 on Software Development
• Managing Projects for Regulatory Compliance
• Speeding Cancer Research with Seapine Tools
• Seapine Customer List in Medical Devices, Pharma/BioTech, and Health Care

Software Solutions

The most common Seapine Software solutions used by health care organizations are:

• Surround SCM - Source code control solution that tracks and manages changes to source code, documents, test data and results, and other digital assets. Learn More
• TestTrack Pro - Workflow and issue management solution that tracks and manages defects, feature requests, tasks, change requests, and other development-related issues. Learn More
• TestTrack TCM - Test case management and test planning solution that manages all facets of the product testing process including test case creation, scheduling, execution [of automated tests], measurement and reporting. Learn More
• TestTrack RM - Requirements management solution that manages requirements and requirements documents, supports coverage and impact analysis, and provides complete artifact traceability. Learn More
• QA Wizard Pro - Software testing solution that automates functional and regression testing of Windows and web applications and the load testing of web applications. Learn More
• Seapine ALM RP - Reporting platform that gives you and your management team insight into every stage of the development lifecycle, enabling fact-based reviews of each project and team. Seapine ALM RP makes it possible to review the schedule status across active projects, investigate test plan performance across teams, analyze bug counts across release cycles, and so on, helping you stay on top of your quality initiatives. Learn More

To learn more about how Seapine Software can help your organization, please contact your business development manager.