Category: Energy and Resources

Implementing an electronic signature in ALM


This is where organisations like the FDA (Food and Drug Administration in the United States) and TGA (Therapeutic Goods Administration in Australia) come in, enforcing regulatory controls around all aspects of the manufacturing process to minimise risk and ensure a high level of quality.

These regulatory bodies understand that effective quality assurance goes much further than just regulating the raw materials and manufacturing process. Any software used to control or support the manufacturing process must also adhere to strict quality standards, because a bug in the software can lead to problems in manufacturing with real-world consequences for patients. Software quality assurance can therefore literally be a matter of life or death l.

To ensure that medical manufacturers conduct satisfactory software testing and maintain the required quality assurance standards, the FDA have published the General Principles of Software Validation document which “outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.”

The JDS solution

JDS Australia recently implemented HPE Application Lifecycle Management (ALM) for one of our clients, a manufacturer of medicine delivering more than 10,000 patient doses per week to hospitals in Australia and overseas. ALM is a software testing tool that assists with the end-to-end management of the software testing lifecycle. This includes defining functional and non-functional requirements for a given application and creating test cases to confirm those requirements are met. It also manages all aspects of test execution, the recording and managing of defects, and reporting across the entire testing effort. ALM enables an organisation to implement and enforce their test strategy in a controlled and structured manner, while providing a complete audit trail of all the testing that was performed.

To comply with the FDA requirements, our client required customisation of ALM to facilitate approvals and sign-off of various testing artefacts (test cases, test executions, and defects). The FDA stipulates that approvals must incorporate an electronic signature that validates the user’s identity to ensure the integrity of the process. As an out-of-the-box implementation, ALM does not provide users with the ability to electronically sign artefacts. JDS developed the eSignature add-in to provide this capability and ensure that our client conforms to the regulatory requirements of the FDA.

The JDS eSignature Add-in was developed in C# and consists of a small COM-aware dll file that is installed and registered on the client machine together with the standard ALM client. The eSignature component handles basic field-level checks and credential validation, while all other business rules are managed from the ALM Workflow Customisation. This gives JDS the ability to implement the electronic signature requirements as stipulated by the FDA, while giving us the flexibility to develop customer-specific customisations and implement future enhancements without the need to recompile and reinstall the eSignature component.

Let’s look at a simple test manager approval for a test case to see how it works.

To start with, new “approval” custom fields are added to the Test Plan module which may contain data such as the approval status, a reason/comment and the date and time that the approval was made. These fields are read-only with their values set through the eSignature Workflow customisation. A new “Approve Test” button is added to the toolbar. When the user clicks this button, the Test Approvals form is presented to the user who selects the appropriate approval status, provides a comment, and enters their credentials. When the OK button is clicked, the eSignature component authenticates the user in ALM using an API function from the HPE Open Test Architecture (OTA) COM library.

If the user is successfully authenticated, eSignature passes the relevant information to the ALM workflow script which sets the appropriate field values. The approvals functionality can be further customised to do things such as making the test case read-only or sending an email to the next approver in line to review and approve the test case.

As it currently stands, the eSignature has been implemented in three modules of ALM – Test Plan for test cases that require two levels of review and approval, Test Lab for test execution records that require three levels of review and approval, and Defects to manage the assignment and approvals of defects. This can easily be expanded to include other modules, such as the approvals of test requirements or software releases.

The JDS eSignature add-in has a very small footprint, is easy to install and configure, and provides our clients with the ability to effectively implement an electronic signature capability as part of their software testing strategy.

If you have compliance requirements or are seeking ways to automate your test management processes, contact our support team at JDS Australia. Our consultants are highly skilled across a range of software suites and IT platforms, and we will work with your business to develop custom solutions that work for you.

Contact us at:

T: 1300 780 432

E: [email protected]

Case Study: CitiPower and Powercor take action to ensure quality

“Technology underpins the ability of CitiPower and Powercor to safely and effectively deliver power to more than a million customers. It’s critical that our applications are current, functioning and available,” says Fiona Hocking, CSA assurance team leader, Powercor.


To deliver top-quality, high-performing business applications that are current, functioning and available


Develop an effective Quality Assurance (QA) discipline for application lifecycles across the enterprise

IT improvements

  • Provides HP Quality Centre (QC) to application groups with zero outages
  • Provides a holistic view of an application testing status
  • Allows application teams to manage up to 30 test cycles with 500 test cases, resulting in the management of over 6,500 defects

About the Client

CitiPower and Powercor are Australia’s leading electricity distributors owned by Cheung Kong Infrastructure Ltd (CKI) and Power Assets Holdings Ltd. Combined, the group operates the largest electricity distribution network in the state of Victoria, servicing over a million customers.

Operating in a highly controlled industry and tasked with providing critical services around the clock, the group relies heavily on its IT infrastructure to deliver energy to customers and to meet regulatory requirements.

This infrastructure is complex to say the least. With over 11 critical business applications, 2,000 users, and multifaceted interfaces to a central information hub for the business facing systems alone, delivery expectations on the IT department are high. Field staff, the group and the government regulator all need real-time information from the electricity network, such as usage patterns, meter data and consumption. Information accuracy and availability can mean the difference between someone getting power or not. Significant penalties apply for missing the mark, so it’s important that the IT department gets it right.



Primary software

  • HP Quality Center

High availability

To deliver on its strategic objectives, the group mandates that its IT department provides high-performing business applications with a 99.8 percent availability rate. There is zero tolerance for level one defects.

As an internal service provider, the Quality Assurance Team had to define how to best facilitate enterprise testing capabilities with limited resources and tight timeframes. At any one time, an application could be managing 20 to 30 test cycles, with over 6,500 defects being handled across its project lifecycle. The Quality Assurance (QA) Team quickly identified that HP Quality Centre (QC) could be of immediate benefit to application owners. Providing a holistic view of an application’s testing status would allow an application owner to assess priorities, allocate resources and deliver quality applications on time and to specification.

In order to be effective and highly responsive when called upon by stakeholders, the QA Team identified three key areas for HP QC success. Firstly, they enlisted support services from HP Platinum Partner JDS Australia to ensure that HP QC continued to be operational with fast issue resolution.

“When it comes to HP Quality Center, JDS keeps the lights switched on. We simply don’t have to worry about HP QC not being available or operational. JDS ensures that we are aware of product developments, new features and functions, and that our system is kept healthy. I know that any time I call them, they can answer my questions. Our HP QC users have aggressive targets, and using JDS as support means that we can keep our users happy,” said Hocking.

Tester training

Secondly, the QA Team packaged training programs that could be easily rolled out when required. As each testing requirement is based on secondment, an application owner can nominate different testers as deemed appropriate. Given that testing groups have often never used testing tools, the QA Team has to equip new testers with the skills needed to get the job done.

“HP QC is very customisable to meet the needs of each specific project. This means that we have to be nimble enough to roll out project-specific training,” says Hocking. “The fact HP QC is intuitive makes the training process easier. In some cases, we can train large groups on the basics in less than thirty minutes. Thirdly, the QA Team assists project teams by helping define testing requirements, developing test scripts, and leveraging HP QC for optimal outcomes.

“Since we were tasked with rolling out HP QC capabilities across the enterprise, we have increased its use by 78 percent and improved user-uptake by 67 per cent.”
With a solid QA platform in place that is supported by JDS, CitiPower and Powercor are now better placed to maintain quality applications under pressure and amidst rapid change.

When the government of Victoria announced its smart meter program for improved accuracy of billing, faster connections and disconnections and real-time usage information, the group welcomed the challenge. The project includes a tight time-frame for the installation of 1.2 million smart meters that can transmit two-way data to a central repository.

Leveraging the capabilities provided by the QA Team, the Advanced Metering Infrastructure (AMI) Network Management System (NMS) support team used HP QC to drive the testing. HP QC is used to ensure that a third-party vendor meets Service Level Agreements (SLAs), that the AMI NMS application (Utility IQ) functions as it is supposed to, and that changes to the application do not present performance risks. HP QC allows the application owner to deliver quality solutions that meet company standards.

Field Mobile Applications

Further adhering to government regulations and business drivers, the group has deployed the Ventyx Service Suite to enable the accurate capture of real-time information from the field through over 500 PDAs. Adopting a thorough end-to-end testing process, the application group has aligned business expectations and security issues with the application itself, according to Alan King, manager, Field Mobile Applications. Incorporating HP QC allowed the team to effectively manage over 500 test cases and improve application functionality with the third-party vendor, based on discovered SLA deficiencies.

“HP QC allows us to manage our vendors and internal customers, as we can negotiate patches and articulate the priorities. It also improves our service levels to our internal customers as they have visibility into the defects and can contribute to the priority fix list,” says King.

Hocking adds: “selecting a high performing tool such as HP QC was the first step but having a skilled group of testing and monitoring consultants behind us makes all the difference. Put simply, JDS keeps the testing technology working so that other critical applications continue to be highly available with minimal defects. We would not have achieved the results without them,” says Hocking.

Powercor and CitiPower will continue to draw upon JDS’s expertise in the areas of technical testing, IT monitoring, and HP Software Support for the future.
“JDS Support has provided outstanding service levels. In the past three years, 60 percent of all support calls have been resolved instantly, and the rest within days,” concludes Hocking. “I can have skilled technicians on-site quickly if I need and can access a large pool of expertise for troubleshooting. With JDS, the Quality Assurance Team has been able to deliver on its service levels and we will continue to work together as we further enhance QA capabilities.”

Business Benefits

  • Rolled out HP Quality Centre across the enterprise to improve uptake of QA processes by 78 percent and increased application performance quality
  • Leveraged HP QC’s capabilities to support application testing for the Smart Meter project
  • Improved quality processes to enable IT application teams to deliver on service levels

Our team on the case

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Why choose JDS?

At JDS, our purpose is to ensure your IT systems work wherever, however, and whenever they are needed. Our expert consultants will help you identify current or potential business issues, and then develop customised solutions to suit you.

JDS is different from other providers in the market. We offer 24/7 monitoring capabilities and support throughout the entire application lifecycle. We give your IT Operations team visibility into the health of your IT systems, enabling them to identify and resolve issues quickly.

We are passionate about what we do, working seamlessly with you to ensure you are getting the best possible performance from your environment. All products sold by JDS are backed by our local Tier One support desk, ensuring a stress-free solution for the entire product lifecycle.

Case Study: Australian Red Cross Blood Service

The prompt and decision

The Australian Red Cross Blood Service performs a critical role in Australia’s health system. It provides quality blood products, essential services and leading edge research to improve the lives of patients. A non-profit organisation with more than 4,000 employees, ARCBS must be ready to respond around the clock to deliver blood and search its extensive records for specialised requirements for particular patients. More than 520,000 Australians are blood donors across 120 collection sites every year.

Over a number of years, and utilising a number of HP Software solutions, JDS has helped the ARCBS adopt a lifecycle approach to quality, performance and availability of key business applications. This has enhanced the ARCBS’s IT capability and there is now a focus on extending the discipline of validation to other systems in the future.

Some of the IT improvements achieved include:

  • Obtaining a single point of truth to for application validation records
  • Unifying functional, performance and quality management
  • Gaining operational efficiencies by migrating to a paperless testing environment
  • Providing visibility into application code issues and the supporting information required for application vendors to ensure a timely fixes

This has provided a number of tangible business benefits such as:

  • Improved ability to meet regulatory audits by access to validation data in hours, rather than days or weeks.
  • Achieving the 99.8 per cent availability service level for the new National Blood Management System (NBMS)

The achievements in this project were realised through the timely and effective deployment of a number of HP Software solutions, including:

  • HP Quality Center as the overarching test management solution
  • HP QuickTest Professional for test automation driven out of Quality Center
  • HP LoadRunner for performance testing across a variety of protocols and application architectures
  • HP Diagnostics to triage performance bottlenecks in application code and configuration
  • HP SiteScope to collect real time metrics from various infrastructure components
  • HP Business Service Management to monitor the performance and availability of the critical applications from both the end user and infrastructure perspectives concurrently.