qmsWrapper Reviews & Ratings

qmsWrapper

4.7 out of 5 stars

Ratings and Reviews 11 Ratings

Total 4.5 out of 5 stars
ease 4.5 out of 5 stars
features 4.5 out of 5 stars
design 4 out of 5 stars
support 5 out of 5 stars

Ratings and Reviews 0 Ratings

Total 0 out of 5 stars
ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

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What is qmsWrapper?

qmsWrapper is a connected Quality Management System (eQMS) designed specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, companies can start with Foundation and expand to Lifecycle and Vigilance as their quality system matures. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects document control, training, CAPA, quality events, risk management, technical documentation, supplier quality, and traceability in one platform. AI assists users with quality processes while every action remains human-controlled and fully auditable. Start where the need is greatest. Keep everything you build. Grow your QMS without rebuilding or migrating to another system.

What is SOFTDMS?

Pharmaceutical and biotechnology companies encounter numerous obstacles when it comes to maintaining control documentation standards in their everyday functions. The effective management and regulation of documents play a crucial role in establishing a robust quality assurance and compliance framework. Regulatory authorities worldwide require businesses operating in regulated sectors to comply with the most recent best practices in their manufacturing operations. To tackle these issues, Pharma Soft Sol has developed a Document Management System (DMS) tailored to enhance the control and distribution of Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs), and other critical documents. Such document management solutions not only reduce compliance expenses but also improve process efficiency and product quality significantly. The softDMS is crafted to ensure timely access to vital information, which minimizes the chances of errors and miscommunication, thereby lowering risks, labor costs, and document inaccuracies. Organizations that adopt this system can expect to experience a more streamlined operation that is in line with regulatory requirements, while also promoting ongoing improvements in their workflows. Ultimately, the implementation of such technological advancements sets the stage for long-term success and adaptability in a fast-evolving industry.

Media

Media

Integrations Supported

Jira

Integrations Supported

API Availability

API Availability

Pricing Information

€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 Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Windows
Mac
Linux

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
On-Site Training

Company Facts

Organization Name

qmsWrapper

Company Location

Canada

Company Website

www.qmswrapper.com

Company Facts

Organization Name

Pharma Soft Sol

Company Location

India

Company Website

softdms.com

Categories and Features

CAPA

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

Quality Management

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

Categories and Features

Pharmacy

Claims Management
Electronic Signature
Forms Management
Pill Database

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