DNA barcoding is the molecular identity method that amplifies and sequences a short standard locus (ITS2, rbcL, matK, psbA-trnH) and matches it to a reference library to confirm botanical species. It is powerful for raw whole or coarsely milled botanicals (NY AG 2015 herbal-supplement findings made it famous), but it does not work on extracts where DNA is degraded or removed — there it must be paired with HPTLC or marker-compound HPLC for a defensible 111.75 identity record.

Regulatory anchors

21 CFR 111.75

How V5 handles it

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.