Dr. Anjali Raja Beharelle,  Co-Founder Collabree

We chose Effectum Medical's Plug & Play QMS because of the minimal configuration required - we simply needed to implement it. The ready-to-use documentation provided a solid foundation, which significantly accelerated our setup. It's comprehensive and saves a lot of time. One challenge was tailoring the system to our needs, especially since we only develop software. This required removing some sections, which might be tricky without prior experience. Fortunately, with our background in medical device development, implementation was smooth.

Regarding the Qualio-based QMS: we're definitely satisfied and would recommend it. Qualio is a robust platform. As one of the first customers using Qualio through Effectum, we experienced a bit of a learning curve, especially since some templates were initially provided as attachments rather than being fully integrated into the system. This was a valuable learning experience, particularly during early audits. With time and experience, and thanks to the successful integration with JIRA, the system has proven to be strong, compliant, and efficient. We've been very happy with the results and have already recommended it to others.

In general, the QMS documents offer excellent guidance and reflect best practices across the board. The system validation was already completed by Effectum, which saved us a lot of time and effort.