“InspectWrk transformed how we manage site safety inspections. The offline capability alone saved us countless hours. Our compliance rate jumped from 72% to 96% in just three months.”
Sarah Mitchell
Meridian Construction Group
Batch Record Software
Need batch record software built around how your plant actually makes product? We provide it. InspectWrk builds digital batch records on our platform, configured to your master records, process steps, in-process checks, and approvals. Book a demo to scope it.
Configured to Your WorkflowFree Setup & OnboardingDedicated Support
4.5/5TrustpilotBased on 3,987 reviews
Quick Answer
Batch record software replaces paper batch manufacturing records with a digital record that follows each batch from start to release. Often called electronic batch record (EBR) software, it guides operators through the approved process steps, captures materials, equipment, and in-process checks as they happen, and routes the completed record to QA for review.
What Is Batch Record Software, and How Does InspectWrk Provide It?
On paper, a batch record is only as good as the last person who filled it in. Entries are missed or written up after the fact, corrections are hard to follow, and a deviation noted in the margin may never reach QA. Review then means reading every page line by line, which delays release and leaves gaps an auditor will find.
How It Works
How Does a Digital Batch Record Run, from Master Record to Release?
This is the workflow we configure for you. Each step follows your own master records, limits, and approval routes.
- 1
Set Up the Master Batch Record
Your approved process becomes a master template: materials, quantities, equipment, process steps, in-process checks, and limits, kept under version control.
- 2
Start the Batch
A batch is created from the current master with its batch or lot number, product, and planned quantity, so every batch runs from the approved version.
- 3
Record Materials and Equipment
Operators record the materials, lots, and quantities used and the equipment each step runs on, and required entries cannot be skipped.
- 4
Follow the Process Steps
Each step appears in order on a tablet or phone with its instructions, and the operator signs it off as it is completed rather than at the end of the shift.
- 5
Run In-Process Checks
Readings such as weights, temperatures, or pH are entered against your limits, and a value outside range prompts follow-up straight away.
- 6
Capture Deviations
Anything that departs from the master record is logged as a deviation with details and photos and routed to QA, instead of being noted in a margin.
- 7
Review and Sign
QA reviews the completed record with exceptions and deviations highlighted, then signs it electronically, and every change stays in the audit trail.
- 8
Record the Release Decision
The responsible person records the release decision, and the complete batch record is stored and ready to export for audits and customers.
What the Batch Record Captures, from Master to Release
The solution covers the record of how each batch is made, for manufacturers in pharmaceuticals, nutraceuticals, cosmetics, food, and chemicals. The scope below is what the solution we build guides and records.
What Gets Checked
- master batch record and version
- batch or lot identification
- materials, lots, and quantities used
- equipment used at each step
- process steps completed and signed
- in-process checks against limits
- deviations and QA review
- release decision and stored record
Common Defects It Surfaces
- entries missed or written up later
- out-of-range reading not followed up
- deviation noted but never reported
- corrections that cannot be traced
- review delaying release
Evidence Captured
- signed step entries
- in-process readings against limits
- deviation records with photos
- QA review and release record
Templates align toyour approved master batch records and SOPsthe GMP requirements that apply to your products21 CFR Part 11 or EU Annex 11, validated by your team where they apply
Rollout
Rolling Out Digital Batch Records
Where Does InspectWrk Sit Beside Your ERP, MES, or LIMS?
InspectWrk is the batch record layer beside your ERP, MES, or LIMS, not a replacement for them. The ERP keeps orders and material lots, control systems run the equipment, and the LIMS keeps laboratory results. InspectWrk owns the record of how each batch was made: steps, entries, checks, deviations, signatures, and review.
What Should Production and QA Validate Before a Pilot?
Validate four things before production use. First, that each master template matches the approved paper record. Second, that limits and required entries behave as expected. Third, that deviations and signatures route to the right people. Fourth, that the configured system passes your own validation for the regulations that apply to you.
Security, Roles, and Records
Batch records are regulated documents, so access matters. Role-based access separates operators, supervisors, QA reviewers, and administrators who maintain master records. Every entry, change, and signature is timestamped and attributed, and completed records are retained for the period your quality system requires.
Rollout Product by Product
A batch record rollout works best one product or line at a time. Start with a product that has frequent paperwork errors or slow release, prove the record there, then add others. Each product carries its own master record, while completed batches and deviations roll up to one view for QA.
Capabilities
Capabilities We Configure for Your Plant
What Batch Record Software covers for your team.
Comparison
What Changes with InspectWrk
Production and QA teams comparing InspectWrk to paper batch records see the difference on five points: completeness, checks against limits, deviations, review time, and the record itself.
| Capability | Without InspectWrk | With InspectWrk |
|---|---|---|
| Completeness | Entries are missed or filled in later from memory, and gaps are found only at review. | Required entries must be completed at each step, so the record is whole when the batch finishes. |
| Checks against limits | A reading outside range is written down, and whether anyone acted on it depends on who noticed. | Values are checked against your limits as they are entered, and out-of-range results trigger follow-up. |
| Deviations | Deviations are noted in margins or on loose sheets and can reach QA late or not at all. | Each deviation is logged in the record with photos and routed to QA for assessment. |
| Review time | QA reads every page line by line before release, which holds up finished product. | Review focuses on the exceptions and deviations the record highlights, so release is not held up by paperwork. |
| The record | Corrections are crossed out by hand, and finding an old batch record means searching an archive. | Every entry, change, and signature is timestamped in the audit trail, and past batches are searchable. |
One Platform. Mobile-First. AI-Powered.
Manage every checklist in one connected workspace, capture evidence on mobile at the point of work, and let AI turn field inputs into clear, stakeholder-ready reports in minutes.
Collaborate
Collaborate with your team anytime, anywhere
See which checklists your team has in progress across every site, jump into the same inspection with one tap, and keep field, supervisor, and back-office views in sync without sending screenshots on WhatsApp.
- Organise inspection data by site, team, and date
- Assign checks to the inspector or vendor responsible
- Track completion across every location in one view
- Keep field and back-office in sync in real time
- Comment on findings without leaving the inspection
Custom Reports
Custom reports that guide your decision making
Every team reports differently. Build the report your operations, quality, or compliance leads actually want to read, share it as a branded PDF, and schedule delivery to the stakeholders who need it.
- Branded PDF and CSV export from any completed inspection
- Schedule weekly or monthly delivery to managers and clients
- Share to email, Drive, Teams, or Slack in one click
- Filter findings by site, severity, or corrective-action status
Powerful Analytics
Analyse your inspection data with confidence
See completion, pass rate, and recurring findings across every checklist and every site, without pulling spreadsheets together at the end of the month.
Who It's For
What Production and QA Teams Get
What changes once batch record software is standardised on InspectWrk.
- Operators follow the approved steps on the shop floor instead of working from a printed record.
- Required entries are completed as the batch runs, so records are whole at the end of production.
- Readings outside your limits and deviations reach QA while the batch is still in progress.
- QA reviews the exceptions rather than every line, so finished product is released sooner.
- Every change and signature is kept in the audit trail, ready for inspections and customer audits.
- We configure the solution to your master records and roll it out product by product.
Reviews From Real People
4.5/5TrustpilotBased on 3,987 reviews
What our
customers are
saying
“The AI-powered defect detection has changed how we work. Our inspectors capture photos and the system flags issues we'd have missed. It's like having an expert reviewer on every site visit.”
James Chen
Pacific Manufacturing Co.
“Rolling out digital checklists across multiple projects gave us instant visibility into recurring safety issues. We now resolve critical findings in hours instead of days.”
Olivia Carter
Northbridge Infrastructure
Ready to Move Batch Record Off Paper?
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Which Inspection Apps Bring This Workflow to iOS and Android?
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Frequently Asked Questions About Batch Record Software
What is batch record software, and is it the same as electronic batch record software?
Yes, the terms are used for the same thing. Batch record software, or electronic batch record (EBR) software, replaces the paper record that documents how each batch was made. It holds the master record for the product, guides operators through each step, captures materials, equipment, readings, and signatures as the work happens, logs deviations, and routes the completed record to QA. InspectWrk builds this on our platform around your own master records and approval routes, so the digital record follows your process rather than forcing a generic one on your plant.
Can you build batch records around our own master records and process steps?
Yes, that is how we work. We start from your approved master batch records and SOPs: the materials and quantities, equipment, process steps, in-process checks, limits, and who signs what. Our team configures those as templates on the platform, keeps them under version control, and sets up the approval routes your quality system requires. Different products can carry different masters, and a change to a master goes through your own change control before new batches use it. Your team then checks the configured records against the paper versions before anything goes live.
How are in-process checks and deviations handled?
In-process checks appear at the step where they belong. The operator enters the reading, such as a weight, temperature, or pH value, and it is compared with the limits in your master record. A value outside range prompts follow-up straight away rather than waiting for review. Anything that departs from the master, such as a missed step, a substituted material, or an unexpected result, is logged as a deviation with details and photos and routed to QA. The deviation stays linked to the batch, so the reviewer sees it in context and can decide what happens next.
Does it include electronic signatures and an audit trail, and is it Part 11 compliant?
The platform records electronic signatures for each step and for QA approval, and keeps an audit trail of every entry and change with the time and the person who made it. Compliance with 21 CFR Part 11, EU Annex 11, or GMP depends on how the system is configured, validated, and used in your operation, so we do not claim it on your behalf. We configure the solution to support your requirements, and your quality team validates it against the regulations that apply to your products before it is used for production batches.
Is this an MES, and does it connect to our ERP, MES, or LIMS?
No, it is not an MES and it does not control equipment. It is the batch record layer: it guides people through the approved process and records what happened. Your ERP can keep orders, stock, and material lots, your MES or control systems can run the equipment, and your LIMS can keep laboratory results. Batch details can come in and completed records and results can go out through exports or integration, so the batch record sits alongside those systems instead of duplicating them. Where you already run an MES with its own batch records, we can scope whether this fits at all.
How do you build and roll out custom batch record software?
We begin by scoping one product: its master record, steps, checks, limits, deviations, and approvals. Our team configures the solution on the InspectWrk platform, your team reviews it against the paper record, and you validate it as your quality system requires. We then pilot it on that product, compare the digital records with what production and QA expect, and adjust before extending to other products and lines. Because the templates are configuration rather than code, adding a new product means adding its master record, not waiting for a new software release.
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Book 30 minutes to discuss your challenges and see how InspectWrk digitizes operations with mobile apps, automated reporting, and real-time dashboards.