A simple QMS solution for lifesciences and bio-med applications.

About Qualcy eQMS

Qualcy eQMS software has been designed for use in Medical Device, Pharma and Biotech applications. The quality management software system complies with 21 CFR Part11 requirements. The software helps companies comply with 21 CFR820, 21 CFR 210 and 211 requirements. The software helps with maintaining ISO13485 standard.

Based on over 20 years of experience of Managing Quality Systems, Qualcy has developed systems that are simple, easy to use and effective.

Qualcy eQMS Features

  • Document management and design control
  • Training Record Management
  • CAPA
  • NCMR
  • Supplier Quality and Equipment management

Additional Applications

In addition to be an end-to-end solution for quality management, Qualcy functionality includes:

  • CMMS
  • Calibration
  • CAPA

CAPA Process

  • User friendly: CAPA is easy to use, easy to implement and easy to configure.
  • Built-in error-proof mechanisms prevent errors from happening during the use of the system.
  • Role based identification, log in and access control, which is very secure and convenient to use.
  • Workflow inbox capabilities provide easy visibility of notifications, tasks, and projects at a single place.
  • Users only see their own tasks and notifications to prevent miscommunication and confusion.
  • The number of Reviewers can be different for each project, or you can assign a minimum number of Reviewers and indicate which departments the reviewers should be from.

Qualcy eQMS Target Market

  • Medical Device
  • Pharma
  • Biotech
  • Life Sciences

Qualcy eQMS Pricing

The cost of Qualcy eQMS software starts at $799 per month. The pricing model includes $99/user/month plus setup fees. There is a free trial available. There is no free version available.

Product Overview

User Reviews of Qualcy eQMS

★★★★★
★★★★★
Submitted on July 27th, 2021 by Marie Becker from Phoenix Flow Biosystems

Qualcy eQMS is user friendly, easy to find the documents and records. The change control feature has been very helpful for us. The Training Management module is integrated with change control, this automatically releases the training assignments, when documents are changed. This has been a big difference, previously we used to spend lot of time on managing the training records. The other modules including CAPA, NC Management and Risk Management are integrated, which makes it easier to link the documents and QMS records.

The Good…

The simplicity and user interface is a big plus. The advanced notifications for tasks and approvals has been useful. The Qualcy team provides excellent support, we are surprised to find that they have team members who have GMP experience, that makes a big difference. They understand the issues and provide feedbacks that are aligned with our GMP/QSR expectations.

The Bad…

The software comes with nice reports, but they are not easy to drill down. Though same data can be obtained through Excel downloads. It takes more steps to get the same data.