"Seapine reviewed our existing SOAP scripts, and made recommendations that greatly improved the reliability and performance of those scripts.
" Markus Korn Software Quality Manager Hirschmann Car Communication |
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Life sciences organizations face constant challenges from competition, government regulations, and productivity and quality issues. To remain competitive, companies must reduce costs, streamline R&D, increase accountability, and accelerate time to market.
Seapine Software solutions help life sciences companies track and manage regulatory compliance initiatives with product development artifacts, verification and validation artifacts, internal validated IT systems, and other mission-critical activities all without interrupting day-to-day activities. Our solutions enable organizations to effortlessly start processes, access work requests, complete tasks, track artifacts, and generate management reports. Our integrated approach makes it easy to automate and enforce workflow processes in order to establish clear accountability, ensure repeatability, and provide complete traceability. Seapine offerings can easily be configured to manage and track regulatory compliance standards such as FDA (USA), PDMA (Japan), MEDDEV (Europe), CMDR (Canada), HIPAA, ISO, and Sarbanes-Oxley.
Below are a few key areas Seapine can specifically help you manage:
- Product Development Lifecycle learn more...
Seapine Solutions for the Product Development Lifecycle
Life sciences companies developing new products are making breakthroughs every day in the ability to treat and prevent illnesses. These products being developed every day help to save and increase the quality of lives. Following the ever-changing Current Good Manufacturing Practice (CGMP) requirements imposed by the FDA and other international standards, following good documentation procedures, and meeting compliance requirements, is all in a day's work. Whether it is creating an artificial heart, or the latest in remote surgery devices, the medical device industry. To bring products to market fast, efficiently and profitable, a well organized strategic method for development, approval, and production is needed.
The FDA requires objective evidence to prove compliance with the creation of requirements documents that illustrate intended use, documented completed test cases, and step-by-step amendment of nonconformities.
Medical device and biotechnology companies are required by the FDA to track any and all changes during the development and quality assurance phases of Class II and Class III devices. There are some incidents where Class I devices may require similar auditing and compliance. Regardless, it is always beneficial to provide the best quality control measures to insure success and your future market potential, because some Class I devices may transition to Class II devices.
Over 60% of the top 10 medical device manufacturers leverage Seapine Software solutions, as well as smaller medical device and biotechnology companies. Many of these smaller life sciences companies cannot afford the risk or time of a non-integrated approach, 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 are taking place with the right people at the right time. Assuring your regulatory team, management team, and investors that appropriate notifications, escalations, auditing, and electronic signatures are incorporated into your daily development and quality assurance processes lessen your risk exposure.
Seapine Software solutions can help create an intuitive and more effective development and quality assurance processes by managing requirements, feature requests, source code, digital assets, issues, test cases, test runs, and automated tests. One huge advantage and value Seapine can deliver is traceability - the nebulous requirement the FDA is auditing on a more frequent basis.
- Validated IT Systems learn more...
Seapine Solutions for the Validating IT Systems
Managing change with purchased or internally developed software systems that require validation, typically require tracking and auditing capabilities for FDA and/or Sarbanes-Oxley compliance. Verification that the changes adhere to GxP is essential with validated systems to assure 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. Since most of these software systems are mission-critical to the success of the organization from a legality and financial standpoint, good change control is essential, regardless if they are validated or not.
Seapine Software solutions can help assure automated notifications are distributed to the team based on specific changes to the system at the same time providing full auditing capabilities and electronic signatures where appropriate.
- Web Site Development learn more...
Seapine Solutions for the Web Site Development
Since the advent of the Internet, pharmaceutical companies have been leveraging web sites to reach out to millions of consumers worldwide to promote the health benefits. Along with this great avenue to market their products, comes more scrutiny from the FDA to insure the appropriate claims, disclosures, and warning are being presented to the public as well. The FDA treats websites more like labeling than advertising, because of the positioning of the product's intended use.
Life sciences companies that leverage the web to market their products need to provide good change control processes during the web site development process. Most of these teams require cross-platform support, as most of the graphical pieces are usually created by Mac users, which we fully support.
Seapine Software solutions can help create an exceptional change control process with a higher level of accountability to insure specific compliance measures are tracked.
Many of the industry's leading biotechnology, clinical research, medical device, and pharmaceutical organizations rely on Seapine Software solutions to manage their core processes, drive results, and gain a competitive edge.
Seapine's comprehensive and flexible solutions offer:
- Centralized data storage
- Role-based security model
- Audit logging and electronic signatures
- Configurable workflow
- Process automation and validation
- Requirements management
- Traceability linking
- Trace matrices
- Impact analysis
- Test case management
- Automated functional testing
- Load testing
- Task and issue management
- Configuration management
- Revision control
- Historical tracking
- Verification and validation
- Quality metrics and reporting for management
Seapine Software solutions are configurable to meet or exceed FDA 21 CFR Part 11 requirements, 21 CFR 210, 211, CGMP, aid in 21 CFR Part 820 compliance, and meet GxP requirements.
A unique approach with Seapine Software is the ease of configuring the offerings and the ability to provide transparent traceability to the users. Since the offering can be purchased together or separate, you'll always have built-in integration for the future or the ability to integrate with other systems using our SDK.
White papers, case studies, etc.
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The most common Seapine Software offerings leveraged by life sciences companies are:
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TestTrack RM for managing requirements and trace matrices
TestTrack RM is a requirements management solution that manages requirements and requirements documents, supports coverage and impact analysis, and provides complete artifact traceability. |
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TestTrack TCM for managing test cases and execution of test runs
TestTrack TCM is a test case management solution that manages all facets of the product testing process including test case creation, scheduling, execution [of automated tests], measurement and reporting. |
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TestTrack Pro for managing feature requests and issue tracking
TestTrack Pro is an issue management solution that tracks and manages defects, feature requests, tasks, change requests, and other development-related issues. |
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QA Wizard Pro for automating functional testing and load testing
QA Wizard Pro is a testing solution that automates functional testing of Windows, Java, and Web applications, and load testing of Web applications. |
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Surround SCM for managing source code and other digital assets
Surround SCM is a source code control solution that tracks and manages changes to source code, documents, test data and results, and other digital assets.
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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.
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