Tag Archive for: Test Management

 

Biofidelity, Genomic Technology Innovator, Selects Jama Connect to Inject Efficiency and Adaptability into the Requirements and Test Management Process Customer Story

Biofidelity chooses Jama Connect to enhance the process previously managed manually with Jira and documents.

Biofidelity, headquartered in Cambridge, United Kingdom, provides innovative technologies that unleash the potential of genomics for fast and accurate targeting and monitoring of cancer treatment.

Biofidelity was founded in 2019 with the goal of enabling millions of lives to be transformed through access to vital information needed for accurate targeting and monitoring of treatments for cancer and other illnesses. They develop innovative molecular technologies that remove the noise from genomic data to make analysis simpler, faster, and more adaptable. Healthcare providers, laboratories, patients, and biopharma firms rely on Biofidelity solutions to provide only the information needed to enable swift decision-making and ensure the best possible outcomes.

Biofidelity’s first product, Aspyre® Lung Reagents, is a research use only (RUO) product that enables simple, fast, and reliable detection of established biomarkers in tissue or blood for use in non-small cell lung cancer research. It includes the lab assay and turnkey cloud analysis software designed to be integrated into a customer’s laboratory. The company’s second product, Aspyre® Clinical Test for Lung, is a laboratory-developed test (LDT) that clinicians use to submit tissue or blood specimens to Biofidelity’s CAP-accredited, CLIA-certified lab for analysis with a quick two-day turnaround time from sample to result.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Challenges

  • No automated change control and review process for requirements and tests
  • Documentation preparation took seven to ten days every quarter
  • Needed to be ready to adapt to changes in regulatory environment

Biofidelity’s competitive edge is in developing products offering simplicity, speed, low failure rates, and sensitivity. As a startup beginning to scale, the company developed their products using a combination of general-purpose platforms, manually tracking requirements and tests, and checking traceability. Managing this information across several documents in separate systems required manual connections, leading to lack of formal traceability between tools. Additionally, while the team could view the history of changes and comments in Jira, there was no established process for reviewing and approving requirements. Significant effort was needed to correctly gather the approved content for release documentation.

For each quarterly product release, the company needed to ensure that all actions were complete and that all information was accurate. However, using Jira made it extremely challenging to consolidate and display all the requirements, test items, and their upstream and downstream relationships. Jira only provided a basic draft table of user needs for verification and left the validation process to be handled manually using a spreadsheet.

The resulting process of generating documents took seven to ten days each quarter. “When we were developing a release, we spent a lot of time creating a traceability matrix by hand in Excel. Trying to connect all the requirements and test item types that were separate in Jira was hugely time consuming,” said Adam French, Associate Director of Software & IT, Biofidelity.

Although mandatory FDA oversight of LDTs were originally slated for 2025, Biofidelity demonstrated foresight by recognizing the need to stay ahead of the evolving regulatory landscape. They took proactive steps to improve their product development processes to ensure they could demonstrate compliance.

The need for better processes was driven by the company’s aim to make Aspyre technology accessible to millions of people affected by cancer each year, which requires the ability to adapt to new target markets more
quickly and easily.

When we were developing a release, we spent a lot of time creating a traceability matrix by hand in Excel. Trying to connect all the requirements and test item types that were separate in Jira was hugely time consuming. – Adam French, Associate Director of Software & IT at Biofidelity

RELATED: Jama Connect Features in Five: SaMD Framework

Evaluation

  • Alignment of requirements with Jira issues
  • Automation of requirements and tests change control
  • Process for reviewing and approving requirements
  • Faster generation of documentation

The company initially set out to find a test management system. However, they quickly discovered that general-purpose project management software, even with plugins, lacked features for requirements management, collaboration, and traceability. In searching for application lifecycle management systems for medical device development, they found Jama Connect, MatrixALM, and Visure Requirements.

After an evaluation involving the software development team, Jama Connect was chosen for its superior configuration, control, and review of changes, and documentation capabilities. Jama Connect and its Software as a Medical Device (SaMD) framework offered flexibility and a depth of configuration that included templates and pre-configured out-of-the-box item types that closely aligned with the team’s existing Jira issues.

The team valued how Jama Connect offers efficient and reliable control over changes to requirements and tests through traceability. In Jama Connect, impact analysis identifies all upstream and downstream traced items affected by a change. Additionally, suspect links are automatically created after changes are made to designated fields, flagging all downstream requirements that may no longer be accurate, complete, or verified.

“Adding control of changes and relations between all item types was the most important thing for us. You can put relationships between Jira issues, but it doesn’t give you the suspect link notification, review process, or control to check upstream and downstream items after you change a source item,” said Max Artomenko, Software Engineer, Biofidelity.

Aside from the Jama Connect product, there were two other reasons for the choice. The Jama Software team spent a significant amount of time answering and asking questions that went to the heart of what the Biofidelity team needed. In addition, a member of the software development team had previous practical experience of how Jama Connect could be effectively integrated into the software development process.

RELATED: QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485

Outcomes

  • Reduced documentation preparation time by 33 – 50%
  • Increased standardization and automation of requirements change control
  • Development process that’s ready for dynamic regulatory
  • Ability to expand into risk analysis and additional teams, products, and markets

With Jama Connect, Biofidelity has reduced documentation preparation time for each release from seven to ten days down to two to three days, a 33-50% reduction. More importantly than the time savings, the team remains confident that the information is correct and ready for FDA audits due to the automated traceability, suspect link notifications, and review processes in Jama Connect.

Jama Connect has standardized how and where all the different teams create and store content. That helps ensure the team is alerted when changes are made and manage changes to team makeup. “Most important for the company is to have one source of truth for all user needs relating to software and hardware requirements, even when the teams change,” said Artomenko.

Unlike in the past, the team can do its traceability analysis in Jama Connect at any moment, even during development. This provides greater control of changes that affect the state of software requirements.

The company successfully transitioned their issue types from Jira into Jama Connect item types and experienced improvements in managing them. The plan is to further expand the management of requirements and tests in Jama Connect by incorporating risk management using the FMEA item type, which is readily available in Jama Connect’s SaMD framework.

By shifting risk analysis from Excel to Jama Connect, the team anticipates gaining more efficient control over risks, including immediate ways to demonstrate that all risk items have mitigations that are implemented and tested.

While the software team was the first to use Jama Connect, additional R&D teams are evaluating Jama Connect to potentially manage their user needs, requirements, and tests for other related products. Jama Connect’s support for reuse of existing requirements and tests could translate into faster development of new products and entry into new markets. “One of the key advantages of Jama Connect is that it improves our processes and makes it easier for us to move into new markets and adapt as regulations change,” said French.

“As we move into a regulated space in the future, we expect to be audited more frequently. With the help of Jama Connect’s SaMD framework, we are getting ready to be able to demonstrate that the quality is there every time.” – Adam French, Associate Director of Software & IT at Biofidelity

DOWNLOAD THE ENTIRE CUSTOMER STORY HERE:
Biofidelity, Genomic Technology Innovator, Selects Jama Connect to Inject Efficiency and Adaptability into the Requirements and Test Management Process

Finnish Red Cross Leverages End-to-End Traceability for Complex Blood Information Project

No organization can thrive for nearly 70 years without evolving its processes, and Finnish Red Cross Blood Service (FRCBS) is no exception. The FRCBS’s Vein-to-Vein project is a prime example of how the organization has evolved to meet the digital age in order to provide the best care possible for those in need.

In 2016, FRCBS began to build the Vein-to-Vein system, a new information system for blood supply chain that covers blood donation and blood product manufacture, storage, and delivery to hospitals nationwide. Blood test results are also integrated into the information system. For the Vein-to-Vein information system project to be successful, data on blood products must work together seamlessly and the chain of data must remain unbroken, making the need for end-to-end traceability an incredibly important component.

This was one of many reasons the FRCBS began their search for a requirements and test management solution that could help them manage the complexity of the project. Their current test management solution, a pieced together system of Microsoft Excel and Microsoft Word documents, could not link risks and requirements to testing. Traceability was lacking, and the team knew the project’s success hinged on a solution that could clearly trace stakeholder requirements through testing, verification, and validation.

Like most organizations in 2020, FRCBS are working remotely throughout the country. Communication and collaboration were top priorities for the team. They knew that version control and review cycles would be compromised if they continued to use Excel and Word for their requirements and test management.

With the Vein-to-Vein information system, we are building the foundation for the digital future of the blood supply chain. It was abundantly clear to us that Word and Excel could not handle the amount of test cases and plans this project required.”

– Susanna Pöhö Development Manager, Digital Services at FRCBS

Finnish Red Cross Blood Services Sees Improved Traceability, Communication, and Collaboration

In June of 2018 FRCBS began onboarding Jama Connect and with the help of CGI Finland — and Jama Software’s easy-to-use platform — they were up and running in 6 months. The FRCBS now uses Jama Connect for testing and risk management.

FRCBS estimates that the testing team has improved their communication and collaboration by 50%, and with the improved communication, the team estimates that their review cycles have been shortened by 80%.

“With Jama Connect, we can link high-level system requirements and risks and test cases. Jama Connect makes it possible to ensure the test cases cover the entire information system, and nothing is being overlooked.”

– Susanna Majuri, System Specialist at FRCBS

Jama Connect has enabled improved end-to-end traceability and test management and allowed the teams to put more efficient processes in place. Because of Jama Connect, FRCBS estimates that the testing team has improved their communication and collaboration by 50%, and with the improved communication, the team estimates that their review cycles have been shortened by 80%.

RELATED: Your Guide to Selecting a Medical Device Development Platform

Audit Preparation Simplified and Shortened

While the system is not technically a CE-marked medical device, the Vein-to-Vein system must meet high quality standards, including GxP quality guidelines and other key regulations. Jama Connect has allowed them to easily demonstrate compliance in a digital format. The FRCBS team estimates that Jama Connect has helped reduce audit preparation time by more than 50%.

“Jama Connect plays a central role in our audit process. We’re able to easily show executed tests, and the whole hierarchy of high-level system requirements, risks, test cases, and scenarios,” said Pöhö.

Finnish Red Cross’ Digital Future with Jama Connect

As the Finnish Red Cross organization continues its efforts to digitize development projects, FRCBS sets a great example with their implementation of Jama Connect.

“We implemented Jama Connect in the middle of large-scale information system project. Our only regret is that we didn’t implement it sooner in the project so we could leverage Jama Connect’s full capabilities,” said Pöhö. “In the future, it will be easier once we widen the range of usage across the organization.” “We’d like to broaden our use of Jama Connect across the company, especially for testing and validation. It’s a new, modern way of working that’s improved our processes immensely,” said Pöhö.

To see more information about the importance of traceability in complex product development, we’ve compiled a handy list of valuable resources for you!

SEE MORE RESOURCES

Safety Standard Compliance

Companies are facing immense pressure to deliver complex products to market faster while balancing rigorous safety standard compliance with standards like ISO 26262 in the automotive industry and DO-178C in aerospace.

Testing plays a key role in the successful development of safety-critical systems. However, many organizations still perform testing manually which can lead to the introduction of errors, inconsistencies in code analysis, delays in project timelines, and increased chances of recalls or failure to meet safety standard compliance.

Teams and managers need to feel audit-ready and confident they are meeting the objectives in these standards. Execution teams need the flexibility to work in their preferred tools to maintain efficiency. Striking the right balance is crucial.

On January 15th, we teamed up with Liverpool Data Research Associates (LDRA) for a webinar discussing how — through a direct integration between the Jama Connect™ and LDRA tool suites — organizations can better strike this balance.

Watch the full webinar here or read the highlights below.

 

Integrating Jama Connect & LDRA for Increased Confidence

Jama Connect makes it easy for teams to define, align, and execute on requirements (high level to low level), tests and other assets across the product development lifecycle. Jama Connect’s built-in traceability can help organizations identify coverage gaps in the product development process. Jama Connect’s Test Management Center supports workflows for manual testing enabling engineering and quality assurance teams to organize and execute requirements-based test plans and test cases to ensure quality and compliance. As products become more complex and automation becomes required, Jama Connect integrates to automated testing tools to support a cost-effective, scalable, and flexible solution

The LDRA tool suite specializes in automated software verification, including the analysis of standards compliance and of structural coverage. The LDRA tool suite can run unit tests, dynamic tests, and static code analysis on embedded software code used to power complex products and systems in regulated industries.

Automated Testing is now commonplace, not only in the unregulated software space, but in safety critical products and systems as well. Manual testing simply will not scale as products become more complex with embedded software. These automated tests and results of automated test runs need to be traced to requirements for compliance and safety reasons.

Through an integration between Jama Connect and LDRA, organizations can combine the strengths of a market leading, fit-for-purpose requirements management tool and a powerful, automated testing tool.

Driving Value

But why integrate? What value does this bring to organizations and teams?

Firstly, by integrating these tools, teams gain efficiency. This integration removes manual export/import processes that waste time and can lead to errors. The nature of the integration gives testing teams greater control over the movement of assets across tools and builds confidence in the overall compliance process.

Additionally, this integration strengthens traceability across tools. Requirements, tests, and test results are published in both tools. Traceability reports can be produced in both tools to review results and analyze system coverage. Teams can gain confidence that the entire system is covered, from requirements down to code.

Lastly, this integration eases the path to compliance and helps strike the balance between speed and safety. Improved efficiency through the integration lets teams work in their tools of choice and makes results available in both tools. Through strengthened traceability, teams will feel more “audit ready” and will help meet the objectives set in rigorous compliance standards like ISO 26262 and DO-178C.

To learn more about how the ISO 26262 standard impacts automotive development, download our white paper.

 

Test Automation and Artificial Intelligence

As we enter a new decade of technological advancements, Jama Software asked select thought leaders from various industries for the trends and events they foresee unfolding over the next 10 years.

In the fifth installment of our 2020s Predictions series, we’re featuring software testing predictions from Ricardo Camacho, Technical Product Marketing Manager at LDRA.

Jama Software: What are the biggest trends you’re seeing in software testing and how are they impacting product development?

Ricardo Camacho: I’m seeing a continued trend in the embracing of test automation. Not just to keep pace with the adoption and refinement in DevOps and Agile practices, but also due to increasing demands in software safety and security which is of great concern in today’s world. Each industry has different challenges, so different needs or focuses in test automation solutions are being sought.

One example of this is in the automotive industry, and particularly in the Advanced Driver-Assistance Systems (ADAS) – a prime example of a complex and evolutionary type of system.  Here you have development of advanced magnetics position sensor in the electronic power steering application, and there are other sensors like speed, inertial, and image which factor into that ecosystem.

These systems are also distributed systems and the components are being provided by different suppliers with different software stacks, using different software development methodologies made up of millions of lines of code. Test automation by way of adhering to a common coding standard for product development for all suppliers establishes a standard platform. In other words, a universal software development platform for vehicle software across all suppliers that address safety, security, and defect-free product goals. Not only have some automotive companies developed their own coding standards to enforce this, but we also see it by the movement and merger of MISRA and the AUTOSAR industry standards.

JS: Are there any technological advancements that you are seeing in software testing

RC: I’m seeing the emerging use of Artificial intelligence (AI) and machine learning for software testing, which continues to evolve and will make an enormous impact. Today, in most organizations, thousands of test cases are created, many are redundant, and some have defects. Also, test scripts are not intelligent enough to determine state conditions of the system under test, so sleep or wait instructions need to be added to properly fulfill testing needs. The interdependencies between test scripts further adds more complexity which tends to cause test failures and script changes. Furthermore, some testing continues to require human interaction, or visual inspection, which makes it error prone. So, AI is the next evolutionary step in software testing.

Artificial intelligence provides many efficiencies and fills many of the missing gaps in software testing. One of the biggest impacts will be through spidering. Where the AI will crawl the application, collecting data and even taking screen shots to learn about the expected behavior of the application. The AI can then compare future runs to known patterns, exposing deviations quickly. AI similarly addresses Application Program Interface (API) testing by recording and mocking responses which significantly reduces the time it takes to perform API testing. Additionally, AI is not limited to just text comparisons in validation. AI can validate all types of data (e.g. video, audio, images).

Therefore, with AI’s help, more robust and reliable test cases are produced and in less time. AI improves test coverage, accuracy, and provides superior insight into the health of the application. AI is bringing a transformation in software testing and it’s here in the horizon. Thus, 2020 will bring forward these types of needed solutions.

Learn how Jama Software is partnering with LDRA to deliver a test validation and verification solution for safety- and security-critical embedded software by watching this video.