Resources

Three places to go deeper than this lesson, or to check a citation yourself before it goes in a real Lakeshore document. All three 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 864.9165, Cornell Legal Information Institute — the regulation that defines BECS (Blood Establishment Computer Software) as a device and classifies it Class II. 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, or to check the special controls this lesson named but didn’t quote (that’s next module’s text).

• 21 CFR 606.60, Cornell Legal Information Institute — the equipment section FDA’s BECS guidance stretches to cover computer systems. Read it in full to see for yourself that its own text and table (centrifuges, thermometers, water baths) were written for physical lab equipment, not software — the guidance is what extends it, not the section’s own wording.