White Papers & Guides


Balancing the Product Development Process

Before you switch to a new product development method or tool, make sure you're balancing development, regulatory and quality, and overall business needs. Learn how balancing these three functional areas will help you improve development speed, foster greater collaboration, and more nimbly respond to change.
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6 Best Practices for Requirements Reuse

To accelerate time to market and reduce costs, many development teams reuse requirements written for previous similar projects. Learn 6 best practices to help you easily reuse requirements.
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All-pairs Testing and TestTrack

In the real world, there is not enough time or enough testers to test every combination of every variable in your application. Learn how all-pairs testing can help you test the right combinations to ensure you covered enough without testing everything.
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5 Practices for Reducing Requirements Churn

Requirements churn or changes to a product's requirements is inevitable, but there are ways to keep it from becoming excessive. Learn 5 practices that will help you reduce unnecessary churn and keep your project on time and on budget.
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9 Tips for Writing Useful Requirements

If you work for a company that has explicitly defined standards for writing product requirements, consider yourself lucky. However, if you're like the rest of us and don't have the benefit of documented standards, the following nine tips can help you write clear, concise, useful requirements.
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Effective Traceability for Embedded Systems Development

For embedded systems developers, documenting and sharing requirements and changes can be complex and costly when traditional, manual methods are used. Learn how an automated product development solution can trace every relationship and change, and provide visibility into data for all team members.
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Achieving IEC 61508 Compliance with Seapine Software

Safety-critical companies can quickly and cost-effectively prove compliance with the IEC 61508 standard by using an integrated solution to manage product development. Read this guide to learn how to meet the requirements and challenges of proving compliance with IEC 61508.
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Managing ISO 26262 Compliance with Seapine Software

Carmakers, their suppliers, and developers of automotive components face new challenges in functional safety and proving compliance with ISO 26262. Learn how to make ISO 26262 compliance verification easier and less error prone with Seapine's product development management solution.
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Reducing Risk With Exploratory Testing

Scripted testing may not find hidden or divergent risks in a product under development. Exploratory testing, however, can expose these risks because it incorporates intuition and experience into testing. Learn how exploratory testing can improve test coverage and help reduce risk in this white paper.
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Risk Management Is Easier Than You Think

Is your team maximizing the time it spends on risk management? Probably not. Identifying, assessing, and mitigating risk is complex and time consuming. Read this white paper to learn how automated traceability can improve safety while reducing the time and cost of your risk management process.
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Managing FMEAs with TestTrack

Failure modes and effects analysis (FMEA) helps companies discover the risks that could occur with a product?both built-in risks and issues that might happen due to how users interact with the product. Learn 7 ways TestTrack improves risk management by making FMEAs more visible.
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Transitioning to Agile Safety-Critical Environments

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.
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Six Tips for System Integration Testing

Learn how to avoid common challenges and conduct a successful system integration test every time with the 6 best practices discussed in this guide.
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Using Root Cause Analysis and TestTrack for Powerful Defect Prevention

Many product development teams use root cause analysis (RCA) to identify the origin of defects and prevent them from recurring. Learn how TestTrack and RCA can help you identify the root cause of issues, evaluate the impact of corrective actions, and monitor their effectiveness.
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Essential Traceability Components for Medical Device Development

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.
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Exposing Risk Throughout Your Product Development Lifecycle

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.
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Five Traceability Components Essential to Driving Business Results

Sharing requirements and changes among development team members can be costly when traditional, manual methods are used. Learn how traceability software can deliver an integrated product development solution that automatically manages complex relationships and artifacts, giving team members the clarity and visibility they need to drive business results.
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Agile in FDA-Regulated Environments

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.
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Six Exercises to Strengthen Traceability

Good traceability strategies and best practices help eliminate unforeseen issues and provide a greater assurance of quality and communication. Complete the exercises in this paper to learn where your traceability is weakest and how to strengthen it.
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Agile Development Methodologies for Testers

By understanding Agile development processes and how testing can improve quality in these processes, testers can define their role as essential to building quality software. Learn how to redefine testing and ensure testing is an essential part of any Agile process.
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Integrating Testing into Agile Development

To ensure that testing resources are effectively used when adopting Agile, managers must plan for the critical role testing has in application development. Learn the steps that you can take to define and integrate testing into an Agile environment.
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Recognizing the Danger Signs of Weak Traceability

Many organizations think their traceability practices are strong enough, but there are always areas for improvement. If your company or department exhibits any of the six symptoms discussed in this paper, your traceability may not be as strong as you think.
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How to Have a Painless FDA Audit

This guide discusses the challenges of meeting compliance initiatives and how product development lifecycle management software solutions can help you survive an FDA audit.
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Analyzing the Impact of Requirement Changes

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.
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Successful Test Case Management: It Takes More Than a Spreadsheet

As software complexity increases and development schedules become more aggressive, teams can be overwhelmed by trying to manage testing with a spreadsheet. Learn more about the benefits of implementing a test case management solution to manage testing.
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Managing Requirement Reviews with TestTrack

Capturing requirement feedback ensures that requirements are complete and team members agree on what will be delivered before implementation begins. This guide discusses the optimal way to request and capture review feedback with TestTrack.
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10 Telltale Signs That You've Outgrown Your Requirements Management Tool

How do you know when it?s time to upgrade to a dedicated requirements management solution? The 10 signs in this guide can help you decide.
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Impact of 21 CFR Part 11 on Product Development

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.
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