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ROI CalculatorDocument Control is the system to create, review, approve, distribute, revise, and archive quality documents, so only current, authorized versions are used.
FDA 21 CFR 211.100 and 21 CFR 820.40 require written procedures to be controlled, approved, available at point of use, and protected from unintended changes. ISO 13485 and ISO 9001 require documented information to be version-controlled, traceable, and retrievable.
Why it matters: because legacy or poor document control causes procedural errors, audit findings, and invalid batch or device records.
