Recently I was part of the FDA 21 Code of Federal Regulations Part 11 (Part 11) audit of one of our custom software development projects. Part 11 audit is mandatory for any pharmaceutical system that uses electronic records and signatures in lieu of paper records. Our audit went surprisingly smoothly, and overall a positive experience for the team, reaffirming my beliefs about the benefits of established development processes and tools. This post briefly covers what contributed to the success of this audit.

Part 11 requires a software development process to be defined and followed. The process should have specific requirements, such as reviews of all the key milestones (e.g. System Requirements), and a well defined Validation phase (functional testing).

One of our internal product development processes was a good starting point for the definition of the process required for this customer project. As all our processes are stored in IRIS Process Author (IPA) in a reusable form, at the outset of the project, we were able to easily make the required adjustments to the selected base process to better suit the project. The process was then shared with the project team in a published form—in the project portal. During the audit, the external auditors carefully reviewed the details of this process and were fully satisfied with its coverage.

I was also required to demonstrate to the external auditors that our team was aware and followed the process. We use Microsoft Visual Studio Team Foundation Server (VSTS) as the development tool. IPA can generate VSTS process templates. In doing so, each activity of the process becomes a work item. In addition, all the process information such as description, steps, and roles, are captured as work items ensuring that every member of the team has access to process information when they need it. Hence the project team was steeped in the process being enacted. This showed the external auditors that the process was fully internalized by the project team and would not be abandoned at times of stress.

VSTS was also used for planning and managing issues, risks, and tasks, a single repository for all project artifacts. As VSTS is tightly integrated with MS Project, project managers were able to generate schedules and track the team’s progress.

In one of my sessions with the auditors, I did not have printouts for all issues and defects with me. When the auditors asked for evidence for certain scenarios, I was able to use VSTS (through web interface), and generate excel spreadsheet for the requested scenarios on the spot. This drove home for me the importance of having a central repository that instantly provide access to all project artifacts, which can be used as direct evidence during the audit process.

I believe process and tools are like two wings of a bird. To fly this bird needs both. Having a well-defined process in place is a great first step but unless the team has the tools that seamlessly incorporate the process into their daily work, the process is not internalized. High performance teams such as ours value being process-centric and disciplined, as long as processes are not a drag on their daily work. The integration of processes with tools not only helps with a positive audit experience, it also results in a motivated and disciplined development organization.

I am pleased to announce the availability of IRIS Process Central Sandbox. This is an online process community to promote discussions on process improvements through collaborative input. Its goal is to bring together process modelers, process consumers, and other stakeholders to freely share information on existing processes and create new process mash-ups.

To facilitate these discussions, we have included several processes on sandbox including MSF for CMMI, OpenUP, and Agile. Where possible, we have provided variety of formats for each process as well as enactment templates.

You can participate by providing your feedback through blogs, discussions boards or modifying the content of the processes. We are eager to get your feedback and will make every effort to ensure that IRIS Process Central Sandbox becomes a valuable asset to you and your organization. Click IRIS Process Central Sandbox to access the sandbox.

IRIS Process Central Sandbox demonstrates how IRIS Process Central which is included as part of IRIS Process Author can help an organization improve their process tailoring in a collaborative environment.

It is our strong belief that through awareness and involvement of process community, there is a great chance of increasing adaptation of processes across the organization. We feel that IRIS Process Central is an important step towards this goal.

We are looking forward to the community participation in IRIS Process Central Sandbox or any suggestions regarding IRIS Process Central product.

On Tuesday October 23rd, I attended the Jazz session in CASCON 07. John Wiegand demonstrated Team Concert which is built on Jazz platform and he took the audience through some project scenarios, mostly from developers’ point of view. I was impressed by Team Concert and liked the user interface, however, as a project manager I was disappointed about the lack of project management support planned for the initial release of Team Concert.

In the beginning of the session, John had mentioned the pain areas that Jazz was addressing, one of which was project management. So I was looking forward to seeing the extend of this support. The functionalities that were demonstrated mostly focused on IDE as well as team collaboration and communication. Project management support was clearly missing, even simple interface to MS Project or MS Excel. I asked John after the session regarding their plan for interfacing to MS Project or MS Excel, he confirmed that it is not part of the initial release of the tool but it is part of their long term plan. He hinted that it is not high in their list of priorities.

From my point of view, for a tool to be used for a small or medium size project, there has to be some project management support. One way to achieve this is by interfacing to MS Project or MS Excel. This would be much simpler than building the support internally and majority of the companies use MS Project and MS Excel. The same way IDE is critical for developer community, interfacing to project management tools is essential for project managements.

We have been using VSTS for enactment of our internal projects and its interface to MS Project is important, although there should be more improvements in this area. I feel that in order for Team Concert to be used in small/medium size team, there needs to be some project management support in place.

In recent years we have seen a trend of software companies, regardless of their size, realizing the benefits of having well defined software development processes in order to increase the success rate of their projects. One cannot argue that when it comes to software processes, one process does not fit all. With this understanding comes the challenge of how to ensure that an organization with a number of software development processes can ensure process selection is made properly.

At the very minimum, an organization needs to have a central place where consumers of the processes can view all available processes and search based on criteria such as process families (e.g. RUP) and process recommendations (e.g. team size). The richer the information included in this process hub, the easier it will be for interested individuals to find the appropriate process. By implementing this central place for processes, companies will see an increase in usage of their software development processes.

The next logical step is for an organization to promote its process center as a vehicle to improve processes through collaborative community input. Traditionally software processes are designed by elite group of highly skilled individuals, often in isolation. Without a feedback mechanism in place, there is no real chance for processes to evolve or survive. With the dynamic nature of software development projects and without the two way approach, processes quickly become obsolete and there will surely be resistance amongst project consumers to follow the processes. Organizations can easily over come this major issue by bringing together the process authors and consumers. Process centre can be a gateway for both parties to come together to share and collaborate on existing processes. The type of feedback can range from the most informal method such as rating system to most constructive such as recommendation on the specific process element or step. By having the wide range of options available, consumers can choose the method which suites them.

A natural way to implement this type of system is through the newly popular Web 2.0 technologies known as the second generation of web-based communities and collaboration tools. This trend in technology and industry addresses the need for collaborative way for the entire organization to work together towards evolving their software development processes and ultimately to increase the success rate of projects. I am pleased to say that we are currently working on a process portal based on Web 2.0 technology which is complimentory to IRIS Process Author. Stay tuned for more blogs regarding IRIS Process Central.