Solutions for Government Systems Development and Integration Testing
Helping Solve Product Development Challenges at Government Organizations
Government organizations have diverse responsibilities, but their software development needs share the common requirements for highly secure solutions, complete forward and backward traceability, and low cost of implementation and ownership.
When compliance is critical, Seapine's solutions have you covered. From Sarbanes-Oxley, to FDA regulation 21 CFR Part 11, to aircraft safety-critical software regulation DO-178B, Seapine solutions track all aspects of development to ensure you have secure processes, complete data integrity, full traceability reports, and management transparency.
Benefits and Highlights
- Gain complete traceability and auditability across all development-related artifacts.
- Automate and enforce workflow processes to establish clear accountability and ensure repeatability.
- Improve the visibility of risk mitigation artifacts across teams, leaving no risk forgotten.
- Increase productivity by automatically creating and maintaining traceability matrices and documentation in minutes.
- Keep all stakeholders informed of new and changed requirements with centralized requirements management.
- Simplify the requirement review process and ensure everyone understands the impact of proposed changes.
- Mitigate your risk exposure with automatic notifications and escalations, automatic audit logging, and electronic signatures that are incorporated into your organization's daily development and quality assurance processes.
- Gain insight into the impact of changes with real-time data visibility, change notifications, and gap and risk analysis.
- Enforce adherence to development processes and best practices with enforceable and secure automated workflows.
- Quickly check on project progress, research specific user and product requirements when needed, and automatically be notified of requirements changes you did not initiate.
- Accurately forecast schedules and enable better decision-making with real-time visibility of project status information.
White Papers & Guides
This guide discusses how TestTrack's impact analysis tools provide a clear picture of relationships between items so you can accurately determine the impact of changing requirements.
This white paper will help you understand the impact of FDA ruling 21 CFR Part 11, and learn how good processes and the right product development management solution tool can help you achieve compliance.
At its core, Agile is a set of concepts and beliefs that stress flexibility and shared responsibility over rigid rules and formal processes. So, can Agile be used in an FDA-regulated environment? Yes. Read this white paper to learn how.
To improve product quality, reduce production costs, and get to market faster, many organizations in safety-critical environments are exploring Agile. Read this white paper to learn about the challenges you may face, and how to overcome them and successfully transition to Agile.
Join Seapine Software life sciences solutions engineer, Michael Sieve, for a 45-minute webinar and learn how to prepare for and survive an audit. Michael will discuss how real-time traceability, gap analysis, and content reuse can help you make your product development process seamless, while enabling you to produce information for the FDA and international auditors at a moment's notice.
When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission?too late to capture the benefits a well-maintained matrix can deliver. During this webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, will discuss five of the benefits gained by maintaining a matrix throughout the project.
Identifying, managing, mitigating, analyzing, and tracing risk is recommended for medical device development by ISO 14971 and the FDA. But how do you ensure risk is visible throughout your development cycle? Traceability is one way you can easily expose these risk artifacts as part of your overall risk strategy.
The FDA and other international standards encourage life sciences organizations to adopt strong traceability practices to help with compliance. Once you learn how to capture key data and create reusable, traceable requirements, what does your organization gain beyond compliance?
The government template demonstrates the TestTrack features that help organizations meet change, quality, technology, and information management requirements. It is pre-configured with workflows, security groups, automation rules, folders, and other features—all of which can be further customized to meet your specific needs. The government template was built from observations in several markets that are known for requiring a high degree of compliance and regulation standards and protocols.
Customer Success Stories
TALX uses TestTrack to help manage compliance with Sarbanes-Oxley and SAS 70.
XL Capital improved tracking of regulatory compliance issues and management of the development process workflow with TestTrack.
8,500+ worldwide customers rely on Seapine Software
The Commonwealth of Kentucky
Federal Bureau of Investigation (FBI)
Federal Emergency Management Agency (FEMA)
LA County Employees Retirement Association
Missile Defense Agency
National Institutes of Health
National Renewable Energy Laboratory
National Weather Service
Sandia National Labs
Tennesse Dept. of Transportation
Tennesse Dept. of Treasury
US Air Force
US Army Corps of Engineers
US Department of Defense
US Department of Homeland Security
US Department of State
Utah Department of Transportation
Utah Tax Commission
Washington Office of Financial Management
Washington State Department of Health