Back to BatchBuddy 📄 EBR | ENTERPRISE

Paper batch records
fail audits.
Electronic ones don't.

BatchBuddy's Electronic Batch Records enforce every step in your manufacturing process. Operators can't skip steps, sign on behalf of others, or complete a record with missing data. The audit trail is cryptographically chained. Every entry is timestamped, identity-verified, and tamper-evident.

21 CFR Part 11-aligned controls · HMAC v3 e-signatures · FDA 483 defensible
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EBR · BATCH BB-2241 · IN PROGRESS
1. Weigh-in, Turmeric Extract
COMPLETE
2. Blend, 45 min at 800 RPM
COMPLETE
3. QC sampling, 3 points
IN PROGRESS
4. Encapsulation
PENDING
5. QA e-signature release
PENDING
🔒 HMAC hash chain: active, every entry locked on save

Every Compliance Control Is Structural

Not guidelines. Not reminders. The system physically prevents non-compliant actions from being taken.

Mandatory checkpoints
Each step must be completed in sequence. Operators cannot advance past a step without required data entries.
FIFO lot allocation
Ingredients are allocated oldest-lot-first, automatically. Operators don't choose which lot to use. The system does.
Identity-verified e-signatures
Operators authenticate their identity at the point of signature. Signing on someone else's behalf is technically impossible.
Tamper-evident hash chain
Every record entry is hashed and chained to the previous entry. Any post-hoc modification breaks the chain and is detectable instantly.
Auto-generated audit trail
The complete who/what/when trail is built automatically as production runs. No separate logging required.
QA release gate
Batches cannot be released to shipping without a QA e-signature. The release gate is enforced in the workflow, not by policy.
Step-level process-loss tracking
Each EBR step can record input and output mass. The system calculates actual vs. expected loss per step, surfaces variances, and auto-calculates the gross-up quantity needed to hit your finished goods target.
Immutable process-loss snapshot
Expected step-loss percentages are captured at run start alongside the scaling snapshot, frozen for regulatory traceability even if the template is later updated.
COMPLETE CHAIN OF CUSTODY

The audit trail runs from your supplier to your client

Your batch record is the centre of the chain. BatchBuddy closes both ends with external party signatures, all stored in the same tamper-evident audit trail.

Supplier e-signs the COA
Invite your supplier to sign their Certificate of Analysis directly in BatchBuddy. Their signature is cryptographically bound to the incoming lot record before your batch begins.
Your QA releases the batch
Every step in the electronic batch record is completed, QC sampling is recorded, and a QA e-signature gates final release. The batch cannot ship without it.
Client acknowledges the QC certificate
Your client signs off the QC release certificate through their own portal. Their acknowledgment is timestamped and added to the same audit trail as every other record in the batch.

All three signatures are electronically bound, identity-verified, and stored in the same immutable audit trail. One FDA request and the complete chain is produced instantly.

Move your batch records off paper. Permanently.

EBR is included in the Enterprise plan. Start a free trial and run your first electronic batch record today.

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