A simple QMS solution for lifesciences and bio-med applications.
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.
In addition to be an end-to-end solution for quality management, Qualcy functionality includes:
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.
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 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 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.