What is a URS (User Requirements Specification)? (Part 2)

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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! 

When crafting a URS a quality representative needs to make sure the equipment or system actually needs a URS or other crucial validation documentation (Validation Master Plan, IQ/OQ/PQ, etc).  A great example in this case is a pH meter.  A pH meter can be placed within a solution to give or record a pH reading which is numbered from 0 to 14 (0 =very acidic, 14= very basic).  In the market today there are many types of pH meters available, from very simple pH meters that take a reading, shows a digital number but does not store any electronic data, to very complex pH meters that take a reading, has password protection, stores the last 200 data entries and can be connected to a printer.  Both systems can be off the shelf purchased systems, but one system needs to have a URS created because of computerized complexity.  In ISPE terms the simple pH meter is categorized as GAMP5 Category 1 piece of equipment which has minimal complexity, while the second pH meter is categorized as a GAMP5 Category 3 computerized off the shelf system as its complexity is elevated because of storage of electronic data and certain programmability.   
 
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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. 
Check out the example URS of the testo 190 Validation Loggers with 21 CFR Part 11 certified software for a more informative step by step process into creating a robust URS!
 

More Info

testo Saveris Pharma

Life Science

Central monitoring of audit-relevant environmental parameters.
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Application Example:

Check out an example URS of the testo 190 Validation Loggers with 21 CFR Part 11 certified software.


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