Life Sciences

Life sciences organizations face constant challenges, including competitors, government regulations, and productivity and quality issues. To remain competitive, life sciences companies must reduce costs, streamline R&D, increase accountability, and accelerate time to market.

Seapine Software’s integrated life sciences solutions help companies manage regulatory compliance initiatives by tracking 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 FDA, PDMA, MEDDEV, CMDR, HIPAA, ISO, and Sarbanes-Oxley, enable organizations to effortlessly start processes, access work requests, complete tasks, track artifacts, and generate qualitiative 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

Seapine Solutions for the Product Development Lifecycle

Staying current with the Good Manufacturing Practice (GMP) requirements, following good documentation procedures, and meeting compliance requirements is all in a day's work for life sciences companies. Whether creating an artificial heart or developing the latest in remote surgery devices, medical device organizations need to bring products to market quickly, efficiently, and profitably. To accomplish this, well-organized development, approval, and production processes are needed.

The U.S. FDA requires traceability and objective evidence that proves compliance through the use of requirements documents, which illustrate intended use, risk analysis and mitigation, documented completed test cases, and step-by-step amendment of nonconformities.

Medical device and biotechnology companies must also track all changes during the development and quality assurance phases of Class II and Class III devices. There are some instances where Class I devices may require similar auditing and compliance. Regardless of the level of device you are developing, it is always beneficial to provide the best quality control measures to ensure success and your future market potential.

More and more life sciences companies are adopting faster development cycles using Agile and other forms of Interative Waterfall methodologies to help drive innovation and bring products to market faster. However, they need a solution that doesn’t get in the way of daily tasks and still documents everything to meet compliance requirements.

Over 60% of the top ten medical device manufacturers use Seapine Software solutions, in addition to many smaller medical and biotechnology companies. The smaller life sciences companies cannot afford the risk or time of a non-integrated software solution, especially if they are positioning for a future acquisition from a larger company.

Seapine Software solutions provide the right amount of configurability to ensure good business-driven processes take place with the right people at the right time. Assuring your regulatory team, management team, and investors that automatic notifications and escalations, auditing, and electronic signatures are incorporated into your daily development and quality assurance processes lessens your risk exposure.

With Seapine Software solutions, you can create an intuitive and more effective development and quality assurance process by centrally managing requirements, risk artifacts, feature requests, source code, digital assets, issues, test cases, test runs, and automated tests. One major advantage and value Seapine can deliver is end-to-end traceability of all artifacts–the vague requirement the FDA is auditing on a more frequent basis.

• Validated IT Systems Learn More

Seapine Solutions for the Validating IT Systems

Managing purchased or internally-developed software systems that require validation typically requires tracking and auditing capabilities to meet FDA, Sarbanes-Oxley, or other compliance requirements. Being able to quickly verify that changes adhere to GxP is essential with validated systems to ensure defects or changes do not affect other areas of the system.

Some of the most commonly managed internal IT systems include compliance, clinical tracking, CRM, document management, financial, ERP, marketing, PLM, and sales. Because most of these software systems are mission-critical to the success of the organization from a legal and financial standpoint, good change control is essential.

With Seapine Software solutions, you can automatically notify team members about changes and provide a way to audit those notification processes. You can create an intuitive and more effective process by centrally managing business requirements, compliance requirements, test plans, verification testing, and issue and change management. Demonstrating traceability and analyzing data is also straightforward and easy. Seapine's solutions also provide full auditing capabilities and electronic signatures where appropriate.

• Web Site Development Learn More

Seapine Solutions for the Web Site Development

Life science companies that use web sites to promote the health benefits of their products face additional FDA scrutiny. These companies must ensure the appropriate claims, disclosures, and warnings are also presented to the public. The FDA considers web sites more like labeling than advertising because of the positioning of the product’s intended use.

Life sciences companies that market their products online need to enforce good change control processes during web site development. Our cross-platform solutions can help you create an advanced change control process with a higher level of accountability to ensure specific compliance measures are tracked.

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 , 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:

• Centralized data storage with a role-based security model
• Audit logging and electronic signatures
• Configurable workflows
• Process automation and validation
• Requirements capture and change tracking
• Risk management
• Automatic artifact linking and traceability matrixes
• Impact 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.

Resources

Videos:

• 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 case studies:

• Life Sciences Solutions Brief
• Five Traceability Components Essential to Driving Business Results
• Agile in FDA-Regulated Environments
• Six Exercises to Strengthen Traceability
• Impact of 21 CFR Part 11 on Software Development
• Recognizing the Danger Signs of Weak Traceability
• OPTI Medical Systems Trains Their Team in Agile
• VirtualScopics Gains Enhanced Product Development Visibility
• How to Have a Painless FDA Audit

Blog articles:

• 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

Software Solutions

The most common Seapine Software solutions used by life sciences companies are:

• TestTrack RM for managing requirements and trace matrices
• TestTrack TCM for managing test cases and execution of test runs
• TestTrack Pro for managing feature requests and issue tracking
• Surround SCM for managing source code and other digital assets
• QA Wizard for automating functional and regression testing, and web load testing

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.