Resources
Free tools, downloads and reference material for anyone writing user requirements for regulated manufacturing systems. Nothing here needs an account.
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Free tools
GMP Impact Assessment
Six plain questions that classify a system as Direct Impact, Indirect Impact or No Impact, with the reasoning path and what it means for qualification scope.
Start the assessmentURS structure preview
Read the full section structure, requirement categories and approvals block on screen before you download anything.
View the structureFree downloads
URS Template Pack (Word)
Blank Word URS: thirteen sections, document control, revision history, traceability matrix and assumptions register.
Get the templateSample URS and Design Qualification
A complete URS and the DQ written against it, for the same WFI storage and distribution system. Read both end to end, or download the pair as one package.
Open the sample packageReference reading
The validation document lifecycle
Every document from URS to periodic review: what each is for, who writes it and which regulation asks for it.
Read the catalogueHow your data is handled
Data residency, retention, encryption and the list of subprocessors.
Read the security page