RapidFacto
Digital BMRIPQCBatch release

Manufacturing & batch records

Digital BMRs, raw and packing material issue, IPQC, finished good testing, wastage, and batch release.

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app.rapidfacto.com / batches / BMR-2025-047 / manufacturing
BMRCardiac Stent III

Batch size 500 units · Manufacturing & IPQC

Step 3 active
Batch progress60%
Manufacturing steps

  • Raw material dispensing

    RM-042 · SS wire 316L

    Done

  • Assembly & welding

    IPQC · Weld strength 45 N

    Done
  • 3

    Surface coating

    IPQC · Thickness

    In progress
    IPQC recording
    12.4 μmexpected 10–15 μm
  • 4

    EO sterilization

    Step 4 of 5

    Pending
3 of 5 steps completeIPQC within spec

Paper BMRs and Excel templates break down under CDSCO scrutiny. RapidFacto mirrors your real Batch Details workspace — eleven tabs from basic details and raw material issue through manufacturing, FG testing, wastage, store transfer, uploads, and audit trail — plus product setup, shop-floor BMR, and fleet analytics.

  • Release batches only when mandatory steps and signatures are complete
  • Trace any batch to materials, equipment, and operators in minutes
  • Generate BMR and release PDFs in one click at batch closure
app.rapidfacto.com / batch-details / BMR-2025-047

Batch Details

11 tabs
Basic DetailsRaw MaterialPacking MaterialManufacturing & IPQCFG TestingQC ChecklistWastageAnalyticsStore TransferUploadsAudit Trail
⚙️

One dossier — every stage

Materials, BMR, QC, wastage, stores, files, audit

app.rapidfacto.com / batch-details / BMR-2025-047

Status timeline

Step 5 of 6
✓
Draft
✓
RM received
✓
PM received
✓
Manufactured
5
FG testing
6
Finished

Tabs unlock with status

Packing Material tab stays disabled until raw material is received.

Batch lifecycle — enforced in software

Tabs and actions unlock as the batch advances. Teams cannot skip raw material issue, packing material, manufacturing, FG testing, or store transfer.

Everything inside Batch Details

Eleven tabs — each with its own UI in RapidFacto. Scroll to see what your team gets on every batch.

app.rapidfacto.com / batch-details / basic

Basic Details

Live timeline
Batch No.BMR-2025-047
ProductCardiac Stent III
Batch size500 units
StatusPending FG testing
RM received
PM received
Manufactured
FG testing in progress
Batch hub

Basic details & batch lifecycle

Every batch opens with a single source of truth — identifiers, product link, quantities, dates, and a visual timeline from draft through release or rejection.

  • Batch number, brand name, internal batch number, pack size, and expected vs manufactured quantity
  • Product model name and number with unit-of-measurement display
  • Start date and date of completion with controlled edits
  • Status timeline: draft → RM/PM requested & received → manufactured → FG testing → store pickup → finished
app.rapidfacto.com / batch-details / raw-material

Raw Material

Lot linked
MaterialLotStatus
  • SS wire 316LSS-042Issued
  • Titanium rodTI-031Requested
Request moreReturn to stores
Materials

Raw material requisition & issue

Request raw materials and semi-finished goods from stores, track fulfillment, and reconcile every lot issued to the batch.

  • Auto-generated requisition from product BOM with lot-level issue from inventory
  • Request more material, order any RM/SFG, fulfill or reject requisitions
  • Return unused material to stores with documented quantities
  • Edit requested-at and issued-at timestamps (with amendment reason in audit mode)
app.rapidfacto.com / batch-details / packing-material

Packing Material

PM gate

PET blister packs · Lot PET-018

Issued 500 sets · Requisition fulfilled

500

Requested

500

Issued

0

Returned

Materials

Packing material requisition & issue

Same disciplined workflow for packing materials — gated by batch status so PM is only requested after RM is in place.

  • Packing material requisition from BOM with store fulfillment workflow
  • Request additional PM, order any packing material, or return to inventory
  • Lot-linked issue with requested and issued timestamps
  • Reject or mark requisitions fulfilled with full history
app.rapidfacto.com / batches / BMR-2025-047 / manufacturing
BMRCardiac Stent III

Batch size 500 units · Manufacturing & IPQC

Step 3 active
Batch progress60%
Manufacturing steps

  • Raw material dispensing

    RM-042 · SS wire 316L

    Done

  • Assembly & welding

    IPQC · Weld strength 45 N

    Done
  • 3

    Surface coating

    IPQC · Thickness

    In progress
    IPQC recording
    12.4 μmexpected 10–15 μm
  • 4

    EO sterilization

    Step 4 of 5

    Pending
3 of 5 steps completeIPQC within spec
BMR

Manufacturing steps & IPQC

Execute your approved step sequence on the shop floor — record parameters, equipment, dates, and in-process QC at every stage.

  • Ordered manufacturing steps from product model with sequence enforcement
  • Record step completion, operators, machines, and contemporaneous timestamps
  • IPQC parameters with expected ranges and recorded values per step
  • Edit step and IPQC details with amendment reasons for auditable companies
app.rapidfacto.com / batch-details / fg-testing

Finished Good Testing

n=20 samples
Sample qty20 / 500 units
  • Dimensional checkPass
  • Sterility sampleIn progress
  • Visual inspectionPending
Release

Finished good testing

Structured FG test steps after manufacturing — sample quantities, step-by-step results, and linkage to batch release.

  • FG testing steps configured on the product model, executed per batch
  • Sample quantity for QC with validation against batch size
  • Record results, dates, and remarks on each testing step
  • Controlled edits with amendment trail for regulated environments
app.rapidfacto.com / batch-details / qc-checklist

In-Process QC Checklist

Round 2

Weld strength

Spec: ≥ 40 N

48 N ✓

Surface finish

Spec: ≤ Ra 0.8

Ra 0.4 ✓

Coating thickness

Spec: 10–15 μm

12.4 μm ✓
Pass verdictGenerate COA
QC

In-process QC checklist

Configurable checklist rounds with verdicts, machine linkage, and certificate of analysis — separate from step-level IPQC.

  • QC checklist entries with parameters, machines, and recorded values
  • Submit pass/fail verdicts with remarks; initiate new QC rounds when needed
  • Verdict history across rounds for the same batch
  • Generate COA PDF from batch and checklist data
app.rapidfacto.com / batch-details / wastage

Material Wastage

3.8% total
SS wire4%
PET film2%
Ti rod7%

628 kg

Issued

604 kg

Used

24 kg

Wasted

Yield

Material wastage

Capture wastage against materials actually used on the batch — with summaries and charts for yield analysis.

  • Record wastage per issued material with reason and quantity
  • Edit or add wastage lines tied to inventory usage
  • Wastage summary statistics and breakdown charts
  • Compare issued, used, wasted, and returned quantities
app.rapidfacto.com / batch-details / analytics

Batch Analytics

Per batch
85%

Step completion

92%

Yield

88%

Quality score

Insights

Per-batch analytics

Inside each batch dossier, see completion, yield, and quality metrics without leaving the record.

  • Manufacturing step completion rate with per-step status
  • Yield percentage with visual indicators (green / amber / red thresholds)
  • Quality score and FG testing progress
  • Doughnut and progress views for at-a-glance batch health
app.rapidfacto.com / batch-details / store-transfer

Store Transfer

Requested
🏭

Production

500 units released

→In transit
📦

FG Stores

Awaiting receipt

Stores

Store transfer & finished goods pickup

When QC clears the batch, request transfer to finished-goods stores and record when stores receive it.

  • Store transfer request linked to batch release workflow
  • Track requested vs received timestamps with status tags
  • Edit transfer times with amendment reasons in audit mode
  • Visible only when batch has an active store transfer record
app.rapidfacto.com / batch-details / uploads

Batch Uploads

2 / 6 files

Drop files here

Max 6 files · 5 MB each

  • 📄 FG-test-report.pdf1.2 MB
  • 📄 IPQC-photos.zip4.8 MB
Evidence

Batch uploads & attachments

Attach supporting documents — external test reports, photos, or customer files — directly on the batch record.

  • Drag-and-drop upload up to six files per batch (size limits enforced)
  • Download and delete attachments with upload timestamps
  • Files stored against batch entity for audit retrieval
app.rapidfacto.com / batch-details / audit-trail

Audit Trail

Part 11 ready

  • IPQC recorded · Step 3

    Priya S. · 10:42

  • RM issued · Lot SS-042

    Rahul M. · 09:15

  • Status → Manufactured

    System · 08:00

Compliance

Batch audit trail

Every change on the batch — materials, steps, QC, transfers — logged in an immutable entity audit log.

  • Full BATCH entity audit history in the Audit Trail tab
  • Who changed what and when, aligned with 21 CFR Part 11 expectations
  • Complements amendment reasons on controlled edits

Production workspace

Product setup, batch lists, shop-floor BMR, and fleet analytics — beyond a single dossier.

app.rapidfacto.com / setup / manufacturing-steps

Product model

BOM + steps

Cardiac Stent III · MDL-CS3

5 manufacturing steps · 3 FG test steps

RM: 4PM: 2IPQC: 12 paramsEquipment: 3
Setup

Product models, BOM & manufacturing steps

Configure once in Setup — raw materials, packing materials, manufacturing steps, IPQC parameters, and FG testing steps — then reuse on every batch.

  • Product models with RM/PM BOM and specifications
  • Manufacturing step sequences with equipment and IPQC definitions
  • Finished good testing step templates per product
  • Units of measurement with conversion rules for production
app.rapidfacto.com / all-batches

All Batches

Production

  • BMR-2025-047

    Cardiac Stent III

    FG testing

  • BMR-2025-046

    Syringe 5mL

    Manufacturing

  • BMR-2025-045

    Guide wire

    Finished
Operations

Batch operations & shop floor

Create batches, run active production, and execute BMR on the floor — including shortcut flows for high-volume lines.

  • All batches and active batches lists with status filters
  • New batch creation from approved product models
  • Batch manufacturing execution UI for step-by-step shop-floor entry
  • Batch manufacturing shortcut for streamlined data capture
app.rapidfacto.com / batch-analytics

Fleet Batch Analytics

Last 90 days

47

Active batches

91%

Avg yield

12

Pending FG

Batch completion trend

Management

Fleet batch analytics

Management-level dashboards across all batches — trends, KPIs, and exportable insights for review meetings.

  • Date-range analytics across the full batch portfolio
  • Completion, yield, wastage, and quality KPIs with charts
  • Line and bar trends for production performance over time
  • Export-friendly views for management review
app.rapidfacto.com / all-machines

Machines & Equipment

Registry

Laser welder

M-014

In use

EO sterilizer

M-022

Available
Maintenance

Machines & equipment

Register equipment used in manufacturing steps and QC checklists — linked to batches and maintenance context.

  • Machine master used in manufacturing and QC checklist entries
  • Equipment registry under Production for traceability in BMR

Explore other modules

ManufacturingQuality controlPurchaseStores & inventoryQMSApprovalsReports & compliance

Quality control

Incoming material inspection, in-process QC, finished good testing, and COA management for medical device manufacturers.

Stores & inventory

Lot-level inventory, stock adjustments, expiry tracking, and batch traceability for medical device manufacturers.

Reports & compliance

20+ automated PDF reports — BMR, COA, inspection reports, purchase orders — with full audit trail for medical device manufacturers.

Walk through your batch workflow live

We'll demo Batch Details, shop-floor BMR, IPQC, FG testing, and release — mapped to how your plant runs today.