Batch records
Batch records assembled while the culture runs.
Bioseon turns bioprocess events, PAT/Raman soft-sensing, operator actions, and control decisions into continuous GMP-ready records with review-by-exception.
Every batch, perfectly cultured.
Review-by-exception for high-volume biologics operations.
Instead of forcing reviewers through every normal event, Bioseon identifies missing context, out-of-envelope behavior, late entries, and unresolved deviations.
- Focus QA attention on exceptions that affect release confidence.
- Connect process context to each flagged record item.
- Reduce reviewer load without weakening control.
Normal events stay visible. Exceptions become actionable.
Built for CDMOs and biopharma manufacturers running mAbs, vaccines, GLP-1 proteins, and advanced therapies.
Audit trails designed for regulated manufacturing.
Electronic records and signatures are captured with identity, timestamp, reason, and linked process state.
E-signatures
Structured sign-off flows for review, approval, and release decisions.
Immutable log
Every action is preserved with before and after values plus record lineage.
Access control
Role-based privileges keep record actions tied to authorized users.
Continuous record assembly from capture to release.
The record is assembled as operations happen, not recreated after the batch ends.
Capture
Pull sensor, recipe, operator, and equipment events into one timeline.
Structure
Map events to GMP record fields, procedures, and expected evidence.
Reconcile
Compare actions, alarms, and soft-sensor context against the batch plan.
Flag exceptions
Surface missing data, deviations, excursions, and late changes.
Release
Package approvals, signatures, and evidence for final quality review.
Attributable
Each action is tied to a verified identity.
Legible
Records remain readable for inspection and review.
Original
Source context is preserved with lineage.
Accurate
Exceptions identify inconsistent or missing evidence.
ALCOA+ data integrity for modern bioprocessing.
Bioseon supports complete, consistent, enduring, and available records across single-use, perfusion, and hybrid manufacturing environments.
- Time-aligned process context
- Traceable operator interventions
- Inspection-ready record packages
Deviation management connected to the process.
Link deviation records to control envelopes, alarms, soft-sensor estimates, and human override decisions.
Context
See the state of culture, equipment, and recipe at the moment of deviation.
Ownership
Assign investigation, review, and closure tasks with action provenance.
Recurrence
Spot repeated patterns that drive reprocessing or delayed release.
Outcomes that matter to release teams.
Bioseon is designed to cut record review time, reduce reprocessing, and improve release confidence.
Exceptions direct attention to high-value questions.
Issues are found while context is still fresh.
Evidence accumulates as the batch runs.
Paper and manual review versus Bioseon.
| Workflow | Manual batch record | Bioseon |
|---|---|---|
| Assembly | After the run, often from multiple systems | Continuous record assembly during execution |
| Review | Line-by-line checks on normal and abnormal events | Review-by-exception with process context |
| Signatures | Disconnected approvals and late evidence | E-signatures tied to record state |
| Deviations | Manual cross-reference and delayed investigation | Linked to control envelopes, alarms, and actions |
Security and validation are built into the record layer.
RBAC, SSO, full action provenance, and validation support help teams place Bioseon inside GxP environments with clear controls.
- IQ/OQ/PQ validation support
- 21 CFR Part 11 and GxP alignment
- Data residency options for regulated teams
Batch record FAQ.
Does Bioseon replace quality review?
No. It gives reviewers structured evidence and exceptions so human approval remains explicit.
Can it support perfusion and single-use lines?
Yes. Bioseon is designed for modern single-use, perfusion, and hybrid bioprocessing environments.
How are deviations handled?
Deviations are connected to process context, owners, investigation notes, and closure evidence.
Turn batch records into an active control system.
See how Bioseon cuts reviewer load and reprocessing across GMP biologics operations.