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Considering adopting Electronic Requirements Management?

​​​​​​Article by Principal Consultant Thomas Hornbæk Svendsen, NNIT​

The process of analyzing, defining, and agreeing on the requirements for IT systems is often a complex and recursive endeavor. Using an Electronic Requirements Management (ERM) system might not resolve these challenges – but it might help facilitate a better overview, make tracking of requirements more efficient and establish a platform for improved collaboration. This article explores what key features an ERM system should encompass – and what to look for when considering moving away from paper-based requirements management.

Managing requirements is traditionally a process that involves using Word for documenting the requirements and Excel for tracking the status. Naturally, you can succeed using Word and Excel, but any experienced requirements manager will tell you that the process is both cumbersome and potentially error prone. In addition, any requirements manager will probably tell you that their job would be easier if the tools at hand provided for the automatic tracking of requirements, their status and references to test scenarios.​

​Such tools actually exist, providing a reliable and superior alternative to the traditional Word- and Excel-based setup. Electronic Requirements Management systems (ERM) can help you reduce the number of errors occurring during the requirements gathering process – as well as help you advance overview. Mature ERM systems can do so because they exploit the strongpoints of database systems by managing requirements as singular data entities that can be combined, tracked, and manipulated as needed.​

This opens up for a whole new way of working with requirements. When requirements can be managed individually – and not as part of a monolithic Word document – updates become much easier and the risk of accidently changing or removing a requirement is significantly reduced.

So what should you look for when assessing the effectiveness and completeness of an ERM system? Although requirements vary from organization to organization, the list below outlines the key functionality that should be available in an ERM system:​

  • Requirements tracking – the ability to create, manage, track, and reference requirements, including version control and revoking deletions. Likewise, it should be easy to move requirements within and between specifications, update contents, and make requirements part of different test paradigms​
  • Base lining – provide efficient tracking of released versions of specifications and facilitate that tests (e.g. IQ, OQ, and PQ) can be managed and tracked against uniquely referable requirements (including handling of different requirement versions)​
  • Configurability – allow administrators to configure and enforce mandatory processes and provide support for users to setup views, menus, and reports based on individual needs. It should also be possible to enforce 21 CFR Part 11 compliant signatures for the appropriate steps
  • Collaboration – enable stakeholders within and outside the organization to engage in collaboration using the ERM system directly or via controlled content exports or collaborative applications
  • Presentation – accommodate needs for presenting requirements using multiple contextual views, allow for advanced reporting, and provide the presentation of specifications in a “document-like” manner that does not compromise the overview when preparing and reviewing requirements

These features can also possibly be provided by using Word and Excel, but when meas

ured against a well-functioning ERM system it will be more cumbersome and error prone. If you sketch the strengths and weaknesses of ERM and Paper-based Requirements Management (PRM) systems in a radar-diagram as shown below, the difference becomes clear. In most aspects, the ERM system will provide a better option for the requirements manager than the PRM system. Requirements tracking, base lining, configuration, and collaboration are far easier to facilitate using an ERM system than Word and Excel. However, Word and Excel may appeal more to the infrequent user who will be able to prepare easy-to-read documents and reports using existing skills.​​​


How to get started with ERM

Start out by determining what type of ERM system to implement. When ready, it is recommended to select a set of requirements that can act as a pilot project, import the requirements to the ERM system, and then explore how they can be organized and referenced. Some ERM systems offer a modular approach where different types of specifications can be arranged in modules that help facilitate an overview.
To ensure that requirements are always organized using the same structure
– regardless of the IT system in question – it is recommended to define and enforce the use of specific templates for different kind of purposes. It is likely that the structure of e.g. a user requirements specification will be different than the structure for a functional specification. Setting up appropriate measures for user access is also recommended, thereby ensuring that the requirements can only be created, updated, and deleted by individuals with the appropriate permissions.


NNIT has extensive experience working with requirements management within the life sciences, including the observance of the regulations stipulated by competent authorities, and always incorporating the relevant subject matter expertise. Our experience covers all of the aspects within requirements gathering, including identification and confirmation of the scope, risk assessments, and traceability to test cases. We are well-versed in working with both PRM and ERM methodology as required.

Article written: May 2018 





Niels Buch Leander +45 3075 5339nbln@nnit.comManaging Consultant Buch Leander



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