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Don't place multiple requirements in a single section. This makes it hard to test and validate each independent requirement.
Each requirement should be numbered and stand on its own.
Don't duplicate requirements in multiple sections. You don't want the same requirements repeated in five different sections
of the document. This causes unnecessary work. Rather, collect the requirements in a general section and test them once.
Need help preparing a URS?
Additional guidance may be found in the International Society for Pharmaceutical Engineering's (ISPE [3]) Good Automated
Manufacturing Practice (GAMP)Guide for Validation of Automated Systems. The JETT [4] (Joint Equipment Transition Team)
Consortium, a special interest group of ISPE, has developed documents and templates to help facilitate the URS process.
--By Kassandra Kania
Kassandra Kania is a freelance writer based in Charlotte, NC. She has covered healthcare packaging for several years, most
recently as a trade publication editor.
SOURCE: http://www.healthcarepackaging.com/five-dos-and-donts-writing-urs
Links:
[1] http://www.rockwellautomation.com
[2] http://www.remmele.com
[3] http://www.ispe.org
[4] http://www.jettconsortium.com
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