Welcome back to the second discussion and example document generation of a User Requirement Specification!  I had promised to go over an example system and help craft a draft URS but first there needs to be a standard for documenting what types of systems need which documentation.  For a good reference on how to generate your documentation to Life Science and Pharmaceutical industry standards see the International Society of Pharmaceutical Engineers or ISPE website (www.ispe.org) for quality documentation on all types of systems.  ISPE has many guides on how to mitigate risks, qualify systems, and create documentation that will be able to stand up to Food and Drug Administration, customers, and internal audits! 

Now that a foundation has been built for our system, what type of information needs to be documented within the URS?  Company procedures should always be followed as each will have different documentation for what sections are required, not required or optional.  The following sections can be inserted into the URS depending on the complexity of the system: 

• Purpose: This describes why this document is being created, for who, what, where and when.
• Scope: This is what system or combined systems will be mentioned in the document.  An equipment summary is also included describing the scope of the project. 
• Definitions: For Acronyms or abbreviations this section is a table to define each term. 
• References:  If when creating this document, you reference certain documentation it can be referenced here with document number and a description.
• Functions: This section is the meat of the document and describes each user requirement with a requirement number, requirement description, and criticality type.  There will be subsections within the “function section” which are dependent on the system.  These sections could be general, process/product, utilities, operational, data, security, safety and so on.