Course Code: ELM-127-01

The 4 Golden Rules When Creating User Requirements [Video]

Requirements should be specific and appropriate for the desired system.

Remember get S-M-A-R-T SMART when developing your requirements.

Each requirement should be:

  • Specific
  • Measurable
  • Achievable
  • Realistic
  • Testable

Clear & Concise

Requirements should be documented in a clear concise manner for the vendors or suppliers.

Do not leave any room for ambiguous requirements allowing scope for the vendors to suggest their product meets the requirement when it doesn’t.

One Requirement at a Time

Do not double up on requirements; make it clear in your URS one requirement at a time.
It will be easier for you to see how the requirement is handled and it will also make it easier for you to test one requirement at a time.

Change Control

Changes to requirements should be controlled.

Change control in requirements management is the process by which any changes needed to the requirements baseline are managed.

Whether the change is big and complex or small and simple they still need to travel the same initial route into the change control process.

Testable

Requirements should be written such that they can be tested.

Individual requirements should be traceable through their entire life cycle.

The use of a trace matrix is a powerful tool to track where each requirement should be tested

For example, either in the:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Or the Performance Qualification (PQ)

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP