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Average Ratings 10 Ratings

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Description

Founded in 2004, Sunday Business Systems (SBS) specializes in providing quality management software and consulting services that help businesses comply with a range of ISO certifications like ISO 9001:2015 and ISO 13485. SBS’s product suite includes tools for document control, asset tracking, corrective actions, and preventive maintenance. Their cloud-based solutions are designed to simplify and automate key business processes, while their consulting services offer expert guidance for businesses aiming for ISO certification or requiring customized software for manufacturing or compliance needs.

Description

qmsWrapper is a connected Quality Management System (eQMS) built for medical device startups and SMEs. It helps organizations move from paper forms, Word documents, and spreadsheets to a scalable, AI-enabled QMS that grows with their business through Foundation, Lifecycle, and Vigilance. Designed for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects documents, quality events, risk, training, CAPA, technical documentation, and traceability in one platform. Best For: - Medical device and SaMD companies implementing or modernizing an ISO 13485 QMS. - Startups and SMEs that want to grow from controlled documents to connected quality workflows without replacing their QMS.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Asset Tracking Database Yes 
FMEA Database Yes 
Jira No 
Q-Med Database Yes 
SBS Ground Control Yes 
SBS Inspection Database Yes 
SBS Quality Database Yes 
SBS Quality Management Software Yes 
SBS T-Med Database Yes 
SBS Training Database Yes 
SBS Vendor Management Yes 

Integrations

Asset Tracking Database No 
FMEA Database No 
Jira Yes 
Q-Med Database No 
SBS Ground Control No 
SBS Inspection Database No 
SBS Quality Database No 
SBS Quality Management Software No 
SBS T-Med Database No 
SBS Training Database No 
SBS Vendor Management No 

Pricing Details

$295
Pricing varies by product and by the number of concurrent users. See individual product pages for detailed pricing.
Free Trial Yes 
Free Version No 

Pricing Details

€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac Yes 
Linux Yes 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Sunday Business Systems

Founded

2004

Country

United States

Website

sundaybizsys.com

Vendor Details

Company Name

qmsWrapper

Country

Canada

Website

www.qmswrapper.com

Product Features

Asset Tracking

Activity Tracking Yes 
Audit Trails Yes 
Barcoding / RFID No 
Checkout / Check-In No 
Depreciation Tracking Yes 
Disposal Tracking No 
Inventory Management Yes 
Location Tracking Yes 
QR Codes No 
Reservations No 
Service History Yes 

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

Compliance

Archiving & Retention No 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing Yes 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance No 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance Yes 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback Yes 
Version Control Yes 
Workflow / Process Automation Yes 

Inspection

Appointment Management No 
Customer Database No 
Dispatch Management No 
Equipment Tracking Yes 
Photos In Reports No 
Print on Site No 
Report Templates No 
Speech Recognition No 
Subcontractor Management No 

Manufacturing

Accounting Integration No 
ERP No 
MES No 
MRP No 
Maintenance Management Yes 
Purchase Order Management No 
Quality Management Yes 
Quotes/Estimates No 
Reporting/Analytics Yes 
Safety Management Yes 
Shipping Management No 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Vendor Management

Audit Management Yes 
Contact Management Yes 
Customer Database Yes 
Self Service Portal No 
Supplier Master Data Yes 
Transaction History Yes 
Vendor Maintained Profiles No 
Vendor Managed Inventory No 
Vendor Performance Rating Yes 
Vendor Qualification Tracking Yes 

Product Features

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management No 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management No 
ISO Standards Management Yes 
Maintenance Management No 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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