Do you need a starting point for a Serialization User Requirement Spec (URS)?

October 10, 2012

One of the challenges to starting any User Requirement Specification (URS) is to envision a structure which can allow for traceability as the project continues.  The attached sample URS is a starting point which is laid out in tabular format to allow easy integration into a Requirements Traceability Matrix (RTM).  The URS is separated into logical sections to prompt the writer to consider what requirements are appropriate for their specific implementation an organized way.  Requirement examples provided in each section are intended to provide some initial ideas which can be further embellished and added to as appropriate for a project.

Once a structure has been established, the other major challenge is to write good requirements. The key attributes of good requirements are:
 
  • Each requirement should be concise.  No more than 200 words.
  • Each requirement should be measurable.  Requirements like “User Friendly” are hard to test.
  • Requirements should only be stated once.  Multiple requirements stating the same need are often contradictory.

This document does not necessarily include all the requirements for your system, but I hope you find this a better starting point than a blank screen!

Download the Microsoft Word version here:

Screenshot of 'Considering URS document'

TAGS:

Pen lying on a paper graph.

Risk-Averse Schedule for Project Management

Is your project schedule ready to pass the Project Management Institute’s (PMI) "litmus test"? Not sure? Well, the Project Management Team at ProPharma is here to lend a helping hand. Below are some...

FDA Proposes New Rule for Distribution Compliance

FDA has announced the availability of a proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs). The proposed rule sets...

The Use of a Target Product Profile Early in Drug Development - A Great Program Management Tool

Let’s face it, drug development is a very long process. It is often hard for scientists in a laboratory to picture their drug actually being manufactured at large scale let alone to imagine it in a...