Articles
Writing on how user requirements are derived, specified and qualified for regulated manufacturing equipment. Everything here is free to read.
What Annex 1 (2022) changed for equipment user requirement specifications
The revised Annex 1 made the contamination control strategy the organising principle for sterile manufacturing. Here is what that means, requirement by requirement, when specifying equipment.
Writing testable requirements: eliminating adequate, suitable and user-friendly
A requirement that cannot fail cannot be tested. How to convert vague qualifiers into acceptance criteria a qualification protocol can verify.
The six parameters you should never assume in a vial filling URS
Six values that decide whether a filling line is fit for the product, and which are almost always inherited from the last project rather than derived from this one.
100,000 vials per day is not a specification — deriving machine speed for a filling line
A daily output figure hides shift pattern, changeover, line efficiency and rejects. Here is the arithmetic that turns it into a nominal machine speed a supplier can quote against.
Why a URS written from a vendor specification fails Design Qualification
A user requirement specification copied from a supplier's technical proposal cannot demonstrate that the design meets the user's needs, because the design and the requirement have the same author.
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