Solving Product Development Challenges at Leading Life Science Companies
Life science companies face constant challenges, including competitors, government regulations, and productivity and quality issues. To remain competitive, these organizations must reduce costs, streamline R&D processes, reduce compliance overhead, and accelerate time to market in a compliant manner.
Seapine solutions can be configured to meet regulatory compliance standards, such as EU, FDA, IEC, ISO, HIPAA, ISO, and Sarbanes-Oxley. This includes meeting or exceeding FDA regulations for 21 CFR Part 11, IEC 62304 & 60601, ISO 14971 & 13485, and cGMP, in addition to helping meet 21 CFR Part 820 QSR compliance and completing GxP assessments.
Benefits and Highlights
- Improve the visibility of risk mitigation artifacts across teams to ensure no risk is left unaddressed.
- Make risk analysis and mitigation processes faster and easier by automating traceability matrices and risk reports.
- Increase productivity by creating and maintaining traceability matrices and documentation in minutes.
- Simplify risk analysis and continually monitor and enforce risk mitigation measures as the product moves through the development cycle.
- 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.
- Help your team work together to create, organize, and run thousands of test cases, track the results, and measure their progress with centralized test management.
- Keep your team in sync regarding outstanding issues, enable analysis and investigation of recurring problems, and trace issues back to their source through centralized issue management.
- Enforce adherence to development processes and best practices with 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.
- Easily integrate Seapine’s tools into your existing applications through a variety of open interfaces, including APIs and an SDK.
White Papers & Guides
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.
Medical device development organizations must manage risks to the safety of patients and medical professionals, adding additional considerations to the process of managing requirements. Learn how traceability-based risk management practices can help you reduce the time spent assessing and managing risk, while supporting device approval.
As you design new medical products, multiple activities, changes, and requirements must be tracked, documented, and responded to by multiple stakeholders. Learn how an automated product development solution can trace every relationship and change, and provide instant visibility into data.
This guide discusses the challenges of meeting compliance initiatives and how product development lifecycle management software solutions can help you survive an FDA audit.
Join Mike Brown, owner at Code Refinery, and Larry Nicholson, life sciences business development manager at Seapine Software, as they share real-world insight into the results of the 2015 State of Medical Device Development Survey.
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.
It's no surprise that the demand for smarter, safer, more connected medical devices has introduced new complexities to the development process. Seapine Software recently surveyed nearly 500 medical device development professionals about the challenges they face getting products to market. Join Larry Nicholson, Life Sciences Business Development Manager at Seapine Software, as he explores these challenges-and more-and what they mean for medical device development professionals.
Join us as John Avellanet, FDA and design compliance expert, provides best practices for incorporating traceability early, inexpensively, and compliantly in medical device development activities, clinical product development, and diagnostic software. You'll learn how you can avoid costly recalls and FDA enforcement by making your traceability practices more productive, without incurring expensive and time-consuming process overhead.
Life Sciences Template
The life sciences template demonstrates the TestTrack features that help medical device and pharmaceutical organizations meet change, quality, and compliance (e.g., FDA 21 CFR 11) 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.
Customer Success Stories
Clinical trials are used to determine if a new drug or medical device is safe and effective. These trials often generate several MRI, CT, ultrasound, and x-ray images, and it's critical to the success of the trial that these images are analyzed and interpreted correctly. VirtualScopics implemented TestTrack to gain greater visibility into their product development lifecycle and improve their compliance efforts.
Ximedica's existing process for artifact submission was labor intensive and costly. With Seapine Software's help, Ximedica created an integrated solution that allowed them to manage compliance artifacts and easily transfer management of that data to clients at the end of a project.
Medical Device Company Adopts Agile for Embedded Systems
2015 Medical Device Development Report
We heard from more than 900 medical device industry professionals, and they had a lot to say. From the current state of medical device development to recommendations for fostering innovation to the future of development, the report covers key takeaways and industry trends learned from this unique survey.