AI Powered QMS for Medical Device Manufacturers
Document control, CAPA, training, and batch records — one platform that keeps you audit-ready for CDSCO inspections and ISO 13485 certification.
Trusted by 20+ manufacturers · full audit trail · e-signatures included
👋 Hi, Neil (Quality Manager)
12
Active Batches
1 Down
Machines (6/7)
4
Open CAPAs
7
Pending Approvals
3
Below Min Stock
Pending Tasks
4 Batches
Being Manufactured
2 Batches
Pending QC
2 GRNs
Pending Material Inspection
1 Purchase Order
Pending Material Testing
My Pending Trainings
ISO 13485 Annual Refresher
Due: 15 Jun 2026
GMP Documentation Practices
Due: 22 Jun 2026
Open CAPAs (1 overdue)
CAPA-047 · Temperature excursion in clean room
INTERNAL AUDIT
CAPA-051 · Supplier COA mismatch
SUPPLIER NONCONFORMANCE
Low Stock Materials (3)
Medical Grade Silicone Tubing
Stock: 45 m · Min: 100 m · Short by 55 m
Upcoming Maintenance
Autoclave AC-02
OverdueQuarterly calibration·28 May
Filling Line FL-01
TodayPreventive maintenance·31 May
My Pending Approvals
SOP-005 · Document Control Procedure
DOCUMENT · QA Document Approval
BMR Batch #MD-2026-0142
BATCH · Production sign-off
Upcoming Audits & Meetings
Internal Audit Q2-2026
12 Jun 2026
Management Review Meeting
18 Jun 2026 10:00
25+
Medical device leaders
All
Audits passed
99%
Paper reduction
Full
Traceability
Always audit-ready.
A complete compliance solution for audits — not just document storage. Every record traced, signed, and inspection-ready when your auditor walks in.
ISO 13485
21 CFR Part 11
CDSCO MDR 2017
EU MDR
- Verified
ISO 13485 QMS
Document control verified
- Verified
21 CFR Part 11
E-signatures compliant
- Verified
CDSCO MDR 2017
Batch records complete
- Verified
EU MDR
Traceability linked
Batch size 500 units · Manufacturing & IPQC
- Done
Raw material dispensing
RM-042 · SS wire 316L
- Done
Assembly & welding
IPQC · Weld strength 45 N
- In progress3
Surface coating
IPQC · Thickness
IPQC recording12.4 μmexpected 10–15 μm - Pending4
EO sterilization
Step 4 of 5
From product setup to batch release.
Configure manufacturing steps on your product model, then execute digital batch manufacturing records with IPQC, finished good testing, and a complete audit trail — all linked to every unit you produce.
Product models & BOM
Raw materials, packing materials, and specs per product
Manufacturing steps
Define step sequences with equipment and IPQC parameters
Digital BMR
Batch records from raw material issue to release
IPQC at every step
Record in-process checks with expected results
FG testing & QC
Finished good testing steps and QC checklists
Wastage & analytics
Material wastage tracking with batch-level insights
Templates, review, and signature — one workflow.
Manage your entire quality system in one place — documents, CAPAs, training, internal audits, logbooks, and management review. Every change versioned, approved, and traceable.
Documents & records
Version-controlled SOPs, folders, and controlled records
Approval workflows
Role-based review with 21 CFR Part 11 e-signatures
CAPA management
Root cause analysis through verification and closure
Training records
Modules, assignments, and competency tracking
Internal audits
Templates, audit instances, and findings management
Logbooks & MRM
Equipment logbooks, complaints, and management review
Document Control Procedure
SOP-005 · v1.4 · released
Approval workflow
- Author
Priya Sharma
Submitted v1.4
- QA Review
Dr. Mehta
Review approved
- ReleaseSigned
Quality Head
21 CFR Part 11 e-sign
e-signature · 21 CFR Part 11
A. Kapoor
- Effective
Document control
Publish to QMS
Linked records
The right person signs off — in the right order.
Stop chasing signatures on WhatsApp. Configure multi-stage, role-based approval chains and attach them to any critical process. Production cannot skip QA. QA cannot release without the Quality Head. Every step timestamped, commented, and e-signed.
Multi-stage workflows
Define ordered steps — stage two only opens after stage one approves
Role-based routing
Route to QA Manager, Production Head, or any custom role — not a fixed person
One approval inbox
Documents, batches, POs, GRN, and CAPA — all pending sign-offs in one place
Comments & audit trail
Every decision logged with who, when, and why — inspection-ready history
Part 11 e-signatures
Password re-authentication at each sign-off, linked permanently to the record
Per-process templates
Different workflows for SOP release, batch disposition, and purchase approval
Awaiting you
SOP-PROD-008 Rev 6
Document · Step 2 of 3
PO-2026-8841
Purchase · Step 1 of 2
CAPA-047 closure
CAPA · Step 3 of 3
Batch release — MD-2026-0312
Sterile Syringe 5mL · 3-stage workflow
- Production Supervisor10:42 AM
Rahul Kumar
Manufacturing verified
- QA Manager11:18 AM
Dr. Mehta
Test results reviewed
- Quality Head11:24 AM
Anita Kapoor
Batch release authorized
21 CFR Part 11 e-signature
A. Kapoor
Sequential · role-based · full audit trail
rapidfacto / approval
Purchase Order · MedSupply Co.
SS wire 316L · Packing film PET · AVL approved
Procurement pipeline
- Done
RFQ sent
3 suppliers · SS wire 316L
- Done
PO approved
PO-2025-184 · MedSupply Co.
- Done
GRN received
GRN-0089 · 500 kg received
- Done
Incoming inspection
Material testing · COA verified
- Done
Released to inventory
Lot SS-042 · shelf A-12
From RFQ to goods received — fully traced.
Manage suppliers, quotations, purchase orders, and goods receiving with incoming inspection — every lot linked to inventory and batch manufacturing.
Approved vendor list
Qualified suppliers with approved materials per AVL
Request for quotation
Send RFQs and compare supplier quotes
Purchase orders
Create, track, and approve POs with full history
Goods receiving (GRN)
Receive materials with lot numbers and shelf tracking
Incoming QC
Material inspection, testing, and COA verification
Rejected materials
Quarantine and disposition of non-conforming lots
Know exactly what's on your shelf — and where it went.
Track every lot from goods receiving through batch consumption. Low stock and expiry alerts keep production running — with full traceability for audits.
Real-time stock levels
Current quantities for raw and packing materials
Lot & expiry tracking
Batch numbers, shelf life, and expiry alerts
Batch traceability
See which batches consumed each inventory lot
Stock adjustments
Controlled adjustments with audit trail
Return requests
Material returns linked to suppliers and GRNs
Export & reporting
Current stock exports for audits and planning
Current Inventory
Raw & packing materials · lot traceable
- SS-042420 kgIn stock
SS wire 316L
SS-042
- PET-01885 rollsIn stock
PET packing film
PET-018
- TI-03112 kgLow stock
Titanium alloy rod
TI-031
- EO-0092 cylinders14 days
EO sterilization gas
EO-009
Batch traceability
SS-042 used in BMR-2025-047
Packaging seal failure · Stent delivery system
ISO 13485 · 8.2.2 · Batch BMR-2025-041
Complaint workflow
Complaint received
Customer · device malfunction
Investigation
Assigned to QA · due 5 days
Root cause analysis
Seal integrity failure identified
CAPA linked
CAPA-051 · corrective action open
- 5CDSCO
Regulatory report
CDSCO vigilance · reportable event
Linked to QMS
CAPA-051 · SOP-012
Catch field issues early — close the loop.
Log complaints, investigate root causes, file regulatory reports, and link CAPAs — all connected to your batches and QMS. Post-market surveillance that auditors actually want to see.
Complaint logging
ISO 13485 8.2.2 — customer, field, and regulatory sources
Investigation & RCA
Structured review from intake through root cause
Regulatory reporting
Flag reportable events and track authority submissions
CAPA linkage
Connect complaints to corrective and preventive actions
Disposition & closure
Approval workflows before closing each complaint
Batch traceability
Link affected products and batches to every complaint
Every report your auditor asks for — generated in one click.
BMRs, material inspection, purchase orders, training logs — audit-ready PDFs with full traceability and e-signatures.
+2 more in this category
Batch Manufacturing Record
BMR-2026-0312
Audit trail
Linked & signed
Digitally signed · 21 CFR Part 11
Pass
Pricing
Get a quote built for your team.
We scope each engagement individually — users, modules, and go-live support. Share your requirements and we'll send a clear, itemised proposal.
Full platform access
Quote on request
Setup, annual licensing, and user accounts — scoped to your operation after a short discovery call.
Request a quotePrefer a walkthrough first? Book a demo
Everything included
One license covers the full RapidFacto platform.
- Manufacturing & batch records
- Full QMS — documents, CAPA, audits
- Purchase, inventory & traceability
- Post-market surveillance & complaints
- 21 CFR Part 11 e-signatures
- Implementation, training & support
FAQ
Common questions from medical device manufacturers evaluating RapidFacto.
RapidFacto is a quality management platform built for medical device manufacturers. It covers manufacturing batch records, document control, CAPA, training, purchase, inventory, and post-market surveillance — in one audit-ready system.
RapidFacto is designed for ISO 13485, CDSCO MDR 2017, EU MDR, and FDA 21 CFR Part 11 (electronic records and e-signatures). Every action is logged with a full audit trail.
We provide custom quotes based on your team size, modules, and deployment needs. Engagements typically include a one-time setup and an annual subscription. Contact us for a detailed, itemised proposal.
Most customers go live within a few weeks. Setup includes configuration, data migration support, and training for your team. Timeline depends on the complexity of your existing processes.
Yes. RapidFacto is built for audit readiness — versioned documents, e-signatures, batch traceability, and complete audit trails. Manufacturers using RapidFacto have passed ISO 13485 and CDSCO inspections.
Yes. RapidFacto is a cloud platform accessible from any browser. No on-premise installation required. Your data is stored securely with role-based access controls.
Yes. A single platform license includes manufacturing, QMS, purchase, inventory, and post-market surveillance. There are no separate module fees.
Yes. You can export documents, records, and reports at any time. Your data belongs to you — we never lock you in.
Still have questions? Contact us