July 19, 2016

Why You Should Stop Using Microsoft Office to Manage Your R&D Process

Helix ALM
Agile

Organizations in safety- and quality-critical environments cannot overcome the barriers to Agile adoption if they’re using Word and Excel

Many organizations are reluctant to join the Agile revolution—especially if they operate in safety- and quality-critical environments. While these organizations recognize the potential benefits of Agile, they believe that there are significant and insurmountable barriers to its adoption. These organizations can succeed with Agile, however—if they’re willing to move away from Microsoft Office.

What Are the Barriers?

When organizations hesitate to adopt Agile development methods, they often voice three specific concerns:
  • Lack of documentation and record-keeping
  • Loss of traceability
  • Inability to demonstrate control of process (regulatory compliance)
Adopting Agile practices doesn’t mean you can’t plan, document, or control your process. However, a key characteristic of any Agile process is the necessity to embrace change as the project progresses, and that is why these areas of concern can be barriers to Agile adoption. Safety- and quality-critical organizations know how difficult change management can be. But are these concerns insurmountable barriers? They can be, if the organization is using the most common approach to managing their R&D process: Microsoft Word and Excel files stored in a document management system. Why? Because the effort required to manage the level of change in Agile processes is simply impractical using these technologies.

The Problem with Office

The fundamental problem with a document-centric approach using Word and Excel is that it does not allow you to adapt to change rapidly enough and still maintain the control and traceability you need. In a complex product, you need to be able to manage and trace requirements, tests, risks, tasks, and other items as individual records. Such a high degree of management is important for many reasons, but it’s critical for change management. Using Word and Excel limits you to managing these items only as parts of documents. A huge effort and significant manual procedures are therefore required to separately determine the status and traceability of, for example, the individual requirements that make up a spec and the tests related to them. That is hard enough to do as a one-off Waterfall event, but becomes increasingly difficult the more changes you introduce, especially later in the lifecycle. This complexity makes life difficult regardless of your development method, but it makes Agile nearly impossible—because Agile relies on an ability to make iterative changes and adaptations as the project progresses.

Breaking Down the Barriers

The only way to break down the barriers to Agile adoption is to stop using Microsoft Office products to manage your R&D process, and start using a suitable tool like TestTrack that can manage and trace individual work items. TestTrack can be configured to meet regulatory compliance standards, such as EU, FDA, IEC, ISO, HIPAA, ISO, and Sarbanes-Oxley. It can meet or exceed FDA regulations for 21 CFR Part 11, IEC 62304 & 60601, ISO 14971 & 13485, and cGMP, in addition to helping meet 21 CFR Part 820 QSR compliance and completing GxP assessments. Regardless of which tool you select, however, moving away from Word and Excel is a pre-requisite to successfully gaining the benefits to be had in adopting Agile. For a deeper look at adopting Agile watch this webinar, Breaking the Barriers to Agile Adoption in Safety- and Quality-Critical Environments.