Our white papers are provided to help you learn more about solving business and technical issues with Seapine solutions.
|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 your data.
|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 already difficult process of developing and managing product requirements. Discover how traceability-based risk management practices can help you both reduce the time spent assessing and managing risk and support device approval by the FDA and other agencies. This 3-page white paper covers best practices and tips to expose product risk throughout your product development lifecycle.
|Five Traceability Components Essential to Driving Business Results|
Documenting and sharing requirements and changes among product development team members can be complex and 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 your team members the clarity and visibility they need to drive business results.
|Linking and Traceability with TestTrack|
Anyone who has participated in product development projects knows that delivering the right product can be a complex and difficult process. Traceability is the key to building the right software, whether software is the product or just a part of the product. Learn how to to define, capture, and follow links between requirements and other artifacts in TestTrack.
|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. Agile teams welcome change to product requirements throughout the development cycle, with all team members working together to deliver a high quality product. In comparison, the FDA requires concrete documentation to prove that processes were followed, features validated, issues addressed, and risks mitigated. Regulations such as FDA's Quality System Regulation (QSR), and standards such as ISO 13485, provide manufacturers of finished medical devices with a framework of basic requirements to use in establishing a quality management system. So, can Agile be used in an FDA-regulated environment? Yes. Despite the apparent differences, it is possible to successfully adopt Agile practices in regulated environments if the transformation is treated with insight and caution.
|Six Exercises to Strengthen Traceability|
Achieving traceability within a product development lifecycle helps ensure that changes are shared across teams, in order to maintain quality and compliance. Good traceability strategies and best practices help eliminate unforeseen issues and provide a greater assurance of quality and communication. If your traceability isn't measuring up, it's time to pull the stakeholders together and complete the exercises in this paper, which will highlight exactly where your traceability is weakest and help you figure out how to strengthen it.
|Agile Development Methodologies for Testers|
Testers who seek to better understand how testing can impact Agile development methodologies, and their roles in Agile testing, must take the lead in defining just what those roles are. 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.
|Integrating Testing into Agile Development|
To make sure that testing resources are effectively used when adopting an Agile methodology, software development lifecycle managers must define an integral role for testers and take steps to ensure that testing continues its critical role in application development. Learn the steps that software managers can take to define and integrate testing into an Agile environment.
|Recognizing the Danger Signs of Weak Traceability|
You know you need traceability in your product development process to ensure quality and manage the impact of change. Many businesses think their traceability process is strong enough, but there are always areas where improving your traceability practices can help your team meet quality, cost, compliance, and schedule constraints. If your company or department exhibits any of the six symptoms detailed in this paper, your traceability may not be as strong as you think.
|How to Have a Painless FDA Audit|
This white paper discusses the challenges of meeting compliance initiatives and how product development lifecycle management software solutions can help you survive an FDA audit.
|Integrating Quality into Every Stage of Development|
This article provides you with some simple ways to implement quality assurance throughout your development process.
|Analyzing the Impact of Requirement Changes|
This article discusses how TestTrack RM's impact analysis tools provide a clear picture of relationships between items so you can accurately determine the impact of changing requirements.
|Successful Test Case Management: It Takes More Than a Spreadsheet|
This article discusses the differences between using a spreadsheet to manage test cases and using a more modern test case management solution.
|The Benefits of Managing the Build Process with Surround SCM Snapshot Branches|
This article discusses the benefits of using snapshot branches to manage the build and release process in Surround SCM.
|Managing Requirement Reviews with TestTrack RM|
This white paper includes tips for helping teams use TestTrack RM's flexible reviewing options to successfully manage requirement reviews.
|10 Telltale Signs That You've Outgrown Your Requirements Management Tool|
This white paper discusses some of the challenges of using general-purpose Microsoft Office tools to manage requirements and provides recommendations for moving to a dedicated requirements management solution.
|Test-Driven Development: Does writing software backwards really improve quality?|
This white paper examines a project that used both test-driven development and traditional development methods to determine if either method impacts software quality.
|Five Issues that Prevent Software Quality|
This white paper examines five common issues that keep software development organizations from achieving quality.
|QRA Fast Facts: Automate|
This white paper highlights results from the quality-ready assessment and explains how test automation significantly improves an organization's ability to complete the required levels of testing without adding resources, lengthening release cycles, or reducing test coverage.
|QRA Fast Facts Series|
This white paper includes key insights and strategic actions organizations can take to immediately improve software quality and increase development and QA productivity.
|QRA Fast Facts: Change|
This white paper highlights results from the quality-ready assessment and explains how integrating change management with other systems, such as issue tracking, helps software development teams realize significant quality improvements.
|QRA Fast Facts: Test|
This white paper highlights results from the quality-ready assessment and explains how integrating test case management with issue tracking significantly increases proficiency and productivity.
|QRA Fast Facts: Track|
This white paper highlights results from the quality-ready assessment and explains how an issue tracking can allow organizations to shift resources to revenue-producing development while streamlining processes and providing a better understanding of the quality of each release.
|Identifying the Cost of Poor Quality|
This white paper discusses the effects of poor quality in software development and provides recommendations for improving quality.
|Quality-Centric Application Lifecycle Management in a Down Economy|
This white paper examines the value of adopting quality-centric ALM, which integrates quality into every stage of the software development lifecycle.
|All-pairs Testing and TestTrack TCM|
This white paper explains how all-pairs testing, supported by tools like TestTrack TCM, can help you identify the minimum combinations of input variables needed to ensure adequate test coverage while substantially reducing your overall testing effort.
|Software Test Management Tools Defined|
This white paper discusses the challenges of managing the testing process and how a new class of software applications, called software test management tools, will help QA teams manage testing more efficiently, estimate test coverage more accurately, and improve the QA process and resulting product quality.
|Avoiding the Pitfalls of Automated Testing|
This white paper discusses some of the common problems that QA teams should be aware of when selecting an automated testing tool and methodology.
|Better Concurrent Development through Branching and Surround SCM|
This white paper discusses how to successfully implement concurrent development using branching and Surround SCM.
|Successfully Automating Development Workflows|
This white paper explains how the right issue management solution can help automate your development workflow, regardless of team size or workflow complexity.
|Beyond the Wild, Wild West: Successfully Managing Web Development|
This white paper discusses the benefits of using version control, issue management, and automated testing tools to easily and cost effectively manage Web development projects.
|Automated Testing: Is It Money Well Spent?|
This white paper includes a straightforward model to help determine if automated testing will save you money or cost you money.
|Breaking Down the Barriers to Collaborative Software Development|
This white paper discusses the benefits and barriers to the three most common approaches to collaboration, as well as an integrated collaboration solution from Seapine Software.
|Change Management: A Cornerstone of the Capability Maturity Model|
This white paper provides an overview of the Capability Maturity Model Integration for Software (CMMI-SW) and best practices for successful implementation.
|Impact of 21 CFR Part 11 on Product Development|
This white paper describes the benefits of using product development tools that are built with compliance in mind to help create and manage FDA-compliant processes.