Analytical Method Transfer (USP 1224) Guideline

Analytical Method Transfer (also called ‘Method Transfer’): A documented process that qualifies a laboratory (i.e., the Receiving Unit) to use an analytical test procedure that originated in another laboratory (i.e.,…

Continue ReadingAnalytical Method Transfer (USP 1224) Guideline

User Requirement Specification (URS) Handling SOP

Standard Operating Procedure (SOP) for Handling of User Requirement Specification (URS) for a computerized system or Instrument / Equipment. User Requirement Specification (URS) is a document that informs the software…

Continue ReadingUser Requirement Specification (URS) Handling SOP