Manual-Add Confirmation

After the operator adds material to a container on the balance and the reading stabilises in tolerance, the operator confirms the dispense. The confirmation captures: who performed it (operator identity + Part 11 e-signature), what was added (material, lot), how much (gross, tare, net read live from the balance), against what target (recipe nominal, basis, corrected target, tolerance band), when (timestamp), and where (booth, balance, station). The confirmation is the legal record under 21 CFR 211.101 that the charge was 'determined and certified'.

• Triggered when in-tolerance reading is sustained for the configured stable-window.
• Captures live balance reading — never operator-typed.
• Performer signs with Part 11 §11.200 e-signature.
• Verifier (second person or automated system) signs per 211.101(c).
• Posts immediately to the eBR with full context; cannot be deferred or batched.

• Two-person — performer signs; second person signs; both required before the next step. Highest assurance, slowest.
• Automated system verification — barcode-driven lot selection + calibrated balance + automatic capture; FDA accepts this in lieu of second person.
• Hybrid — automated for routine charges, two-person for critical actives or first-of-day.
• Whichever model, the eBR records WHO/WHAT verified, WHEN and AGAINST WHAT.

• Confirmation can never be retro-dated — timestamp is the moment of action.
• Edits after confirmation are corrections (with rationale, e-signature, both old and new values retained) — never overwrites.
• Cancelled confirmations remain in the audit trail with reason captured.
• Operator who performed the dispense cannot also sign as verifier (11.200(b)).
• Offline confirmations (if supported) post on reconnect with original timestamps preserved.

• Operator confirms before in-tolerance is reached — short-charge accepted silently.
• Operator types the net weight instead of reading from the balance — transcription error.
• Same user signs as both performer and verifier — Part 11 violation; common with shared credentials.
• Confirmation deferred to end of shift — 'batch confirmation' breaks contemporaneous data integrity.
• Cancelled confirmation deleted instead of audit-trailed — investigators see only the final attempt.
• Free-text override on tolerance applied without deviation — the limit becomes negotiable.

• Pharma OSD — automated system verification with periodic supervisor review; two-person for first dispense of a new lot.
• Pharma sterile — two-person verification per Annex 1 expectations for aseptic compounding.
• Biopharma — automated for buffer prep; two-person for cell-bank handling.
• Cosmetics — automated; second-person spot-checks.
• Food — gravimetric verification at IPC stations; per-charge confirmation lighter weight.
• Cannabis — per-charge confirmation explicit per state-regulator track-and-trace rules.