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Total 4.5 out of 5 stars
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features 4.5 out of 5 stars
design 4 out of 5 stars
support 5 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 CSols AqcTools?

CSols AqcToolsâ„¢ v2.6 serves as a flexible platform that allows users to efficiently visualize Analytical Quality Control (AQC) charts, which aids in overseeing laboratory performance while supporting paperless, traceable investigations into any breaches of control limits. This software proves especially beneficial for clients across diverse fields, such as water and environmental testing, public health, and industrial laboratories that perform chemical, clinical, and microbiological analyses. AqcTools provides a variety of 'dynamic, interactive' charts, ranging from standard 'individually plotted AQC points' to those that display batch or daily averages, effectively accommodating both current and historical data sets. Additionally, the platform allows users to create charts tailored to specific analysts, which assists in the continual assessment of analyst performance within the laboratory. Furthermore, all relevant information linked to each data point, including date, batch number, analyst, and instrument, is easily accessible with a single click, simplifying the review process and boosting overall operational efficiency. This innovative solution not only enhances data management but also significantly elevates the quality assurance practices within laboratory settings, ensuring that standards are consistently met and maintained. As a result, laboratories can confidently improve their testing accuracy and reliability.

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.

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
Webinars
Online Training

Company Facts

Organization Name

qmsWrapper

Company Location

Canada

Company Website

www.qmswrapper.com

Company Facts

Organization Name

CSols

Date Founded

2001

Company Location

United States

Company Website

www.csols.com/wordpress/aqctools-v2-6-product-release/

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

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