V5 Ultimate
Records

BPR elements per 21 CFR 111.255

TL;DR

The Batch Production Record (BPR) under 21 CFR 111.255 is the executed record for one batch, prepared from and matching the MMR. It must capture identity & weight/measure of each component used, in-process and finished-product specifications, equipment used, date and time of e...

The Batch Production Record (BPR) under 21 CFR 111.255 is the executed record for one batch, prepared from and matching the MMR. It must capture identity & weight/measure of each component used, in-process and finished-product specifications, equipment used, date and time of each significant step, identity of each person performing/verifying, sampling/test results, label reconciliation, deviations and their investigation outcome, and the QA disposition signature.

Regulatory anchors
  • 21 CFR 111.255
  • 21 CFR 111.260
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.
Related terms
MMR elements per 21 CFR 111.205
Want to see BPR elements per 21 CFR 111.255 in V5?

Free trial, no credit card, onboard in days, not months.

Start freeBook a demo
Back to glossary