Batch Record Management
Right-first-time electronic batch records
Design master batch records, execute them electronically on the shop floor, and review by exception. Every entry is attributable, contemporaneous, and permanently recorded.
Overview
Why batch record management matters
Paper batch records are where data-integrity risk concentrates: missing entries, out-of-sequence steps, illegible corrections, and review cycles that hold finished product in quarantine for weeks. Zixov Batch Record Management moves the batch record itself into the system — designed once as a master template, executed electronically on the shop floor, and reviewed by exception.
Master batch records are built with enforced activity sequencing, in-process checks, calculations, and dual-verification points. During execution, operators can only complete steps in the permitted order, entries are validated as they're made, and any excursion is flagged and captured as a deviation in real time — not discovered at review three weeks later.
Because clean steps are verified at the point of execution, QA review focuses only on the exceptions. Combined with full batch genealogy and ALCOA+-compliant data capture, that turns batch release from a document-checking exercise into a decision.
80%
reduction in batch review time
50%
fewer documentation errors per batch
100%
attributable, contemporaneous entries
Typical outcomes reported by teams moving from paper and spreadsheet-based processes to Zixov.
See it in action
Batch Record Management inside Zixov
A look at the actual screens your team will work in — pick a view or let the tour play through.
Electronic execution with enforced step order — operators can only do the next right thing.
Challenges we solve
The problems this module was built to fix
Batch review bottlenecks release
Reviewing every line of a paper record delays release by days or weeks. Review-by-exception surfaces only flagged entries, cutting review effort dramatically.
Data-integrity gaps on the floor
Late entries, missing initials, and correction fluid are audit magnets. Electronic execution enforces contemporaneous, attributable entries with validated values.
Deviations discovered too late
On paper, excursions surface during review — long after the batch moved on. In-line capture raises the deviation the moment it happens, while evidence is fresh.
No usable batch genealogy
Tracing materials and equipment across batches from paper is near impossible. Electronic records give full forward and backward traceability in seconds.
Capabilities in depth
What BRM does, in detail
Master batch record design
Build MBR templates with activity sequencing, parameters, calculations, and verification points — version-controlled and approved like any controlled document.
- Drag-and-drop activity and phase sequencing
- In-process checks with limits and auto-calculations
- Versioned, approved templates under change control
Electronic execution
Operators execute batches on the shop floor with enforced step order, validated entries, and dual verification where your process requires it.
- Enforced step sequencing with conditional branching
- Real-time entry validation against specifications
- Dual verification and witness sign-offs at critical steps
Exception management
Out-of-limit entries, skipped checks, and process excursions are flagged immediately and routed into Deviation Management with full batch context attached.
- Automatic exception flagging during execution
- One-click deviation creation with batch context
- Exception dashboard for in-progress batches
Review-by-exception & release
QA reviews only flagged entries against the full record, with batch genealogy and audit trail available inline — accelerating disposition decisions.
- Exception-focused review workspace
- Full batch genealogy and material traceability
- Release sign-off with complete ALCOA+ audit trail
How it works
The batch record management lifecycle in Zixov
Design
Author the master batch record with sequenced activities, checks, and verification points; approve it under change control.
Issue
Instantiate an executable batch record for a specific batch, locked to the approved MBR version.
Execute
Operators work through enforced steps with validated entries; exceptions flag deviations in real time.
Review
QA reviews by exception, with every flagged entry linked to its investigation and resolution.
Release
Disposition the batch with e-sign-off, backed by complete genealogy and audit trail.
At a glance
Everything included
Master batch record templates with activity sequencing
Electronic batch execution with enforced step order
In-process checks, dual verification, and deviations capture
Review-by-exception to accelerate batch release
Batch genealogy and full traceability
ALCOA+ compliant data capture with audit logging
FAQ
Common questions about batch record management
How long does it take to digitize our batch records?
Most teams start with one product line. A typical MBR is templated, reviewed, and approved within days once the paper master is finalized — and subsequent products reuse common phases and checks.
Can operators use tablets on the shop floor?
Yes. Execution runs in a browser on tablets and workstations, with large-format entry screens designed for gowned operation.
What happens if a value is out of limits?
The entry is flagged immediately, the operator is prompted per your configured response (block, warn, or require verification), and a deviation can be raised in one click with the batch step context attached automatically.
Does it integrate with our equipment or LIMS?
The module is designed API-first, so balance readings, environmental data, and LIMS results can be brought into batch steps as your integration roadmap matures. Talk to us about your instrument landscape.
Better together
Works together with
Batch Record Management is one part of a connected quality suite — records flow between modules automatically, so nothing is re-entered and nothing falls through.
See Batch Record Management in a live demo
30 minutes, tailored to your workflows — bring one of your own processes and watch it run in Zixov.