Seapine Software’s integrated life sciences solutions help companies manage regulatory compliance initiatives by tracking and linking product development artifacts, verification and validation artifacts, internal validated IT systems, and other mission-critical activities—all without interrupting daily activities. Our solutions, which can be configured to meet regulatory compliance standards, such as EU, FDA, IEC, ISO, HIPAA, ISO, and Sarbanes-Oxley, enable organizations to effortlessly start processes, access work requests, complete tasks, track artifacts, and generate qualitative and analytical reports for management.
Following are a few of the key life sciences areas that Seapine can help you manage:
Product Development Lifecycle Learn More
Validated IT Systems Learn More
Web Site Development Learn More
Leading biotechnology, clinical research, medical device, and pharmaceutical organizations rely on Seapine Software solutions to manage their core processes, drive innovation, and gain a competitive edge. Seapine solutions are configurable to meet or exceed 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.
Seapine’s comprehensive and flexible solutions offer:
- Centralized data storage with a role-based security model
- Audit logging and electronic signatures
- Configurable and enforceable workflows
- Process automation and validation
- Requirements capture and change tracking
- Risk management
- Automatic artifact linking and traceability matrices
- Data, impact, gap, and risk analysis
- Creation and tracking of test cases
- Automated testing and load testing of applications
- Management of issues and tasks
- Configuration management
- Revision control
- Historical tracking
- Verification and validation
- Quality metrics and reporting
- Built-in integration and open interfaces
Our scalable, team-based tools can be used separately or seamlessly integrated for end-to-end traceability of artifacts and more efficient control of the development process. You can also easily integrate Seapine’s tools into your existing applications through a variety of open interfaces, including APIs and an SDK.
Establish clear accountability, ensure repeatability, and provide transparent traceability with Seapine Software.
- Leveraging Traceability in Your Risk Management Strategy
- Leveraging Reusability and Traceability in Medical Device Development
- Gain More Than FDA Compliance Through Traceability
- FDA Expectations for Traceability in Device & Diagnostic Design
- Recording Objective Evidence with TestTrack
- Achieving Electronic FDA Compliance with TestTrack
- Reporting with Seapine's TestTrack for FDA Submissions & Validation
White papers and customer stories:
- Life Sciences Solutions Brief
- How to Have a Painless FDA Audit
- Impact of 21 CFR Part 11 on Software Development
- Recognizing the Danger Signs of Weak Traceability
- Six Exercises to Strengthen Traceability
- Five Traceability Components Essential to Driving Business Results
- Agile in FDA-Regulated Environments
- OPTI Medical Systems Trains Their Team in Agile
- VirtualScopics Gains Enhanced Product Development Visibility
- Why are most life science companies still using 1990s technology?
- When should I start better managing my development artifacts?
- Traceability Exercises to Help Avoid an FDA 483 Warning
The most common Seapine Software solutions used by life sciences companies are:
- Surround SCM - Manage changes to source code, documents, test data and results, and other digital assets. Learn More
- TestTrack - Manage product development with end-to-end traceability of requirements, risk, trace matrices, change requests, issues, defects, tasks, test cases, test runs, and test results. Learn More
- QA Wizard Pro - Automate functional and regression testing of Windows and web applications and the load testing of web applications. Learn More
- Seapine ALM RP - Gain insight into every stage of the product development lifecycle, enabling fact-based reviews of each project and team. Learn More
To learn more about how Seapine Software can help your organization, please contact your business development manager to explore an easier way to manage daily activities and remain compliant.