Resources

Four places to go deeper than this lesson, or to check a citation yourself before it goes in a real Lakeshore document. All four were checked and loading at the time this page was written.

• FDA guidance page: Blood Establishment Computer System Validation in the User’s Facility — FDA’s own guidance-database listing for the document this lesson quotes throughout (final, April 2013, CBER). Use this page to confirm you’re citing the current, final version, and to download the PDF directly from FDA rather than a mirror.

• 21 CFR 211.68, Cornell Legal Information Institute — the regulation behind “validation before routine use” and the record-retention citation this lesson names (211.68(b)). Cornell’s free, citable, plain-text CFR mirror — use it when you need to hand someone the regulation itself without an eCFR login or PDF.

• 21 CFR 606.160, Cornell Legal Information Institute — the quality-control-records section (606.160(b)(5)(ii)) that FDA’s BECS guidance cites alongside 211.68(b) and 211.100(b) for retaining validation records. Read it when you need the retention requirement’s own regulatory text, not just the guidance’s citation of it.

• FDA guidance page: General Principles of Software Validation — the January 2002 guidance FDA’s BECS guidance itself points to (as “Ref. 1”) for concepts like “level of confidence” and software regression testing. Written for device manufacturers, not user facilities like Lakeshore, but useful background on where the BECS guidance’s own vocabulary comes from.