SimplerQMS vs. Qualio

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

Qualio is a cloud-based life sciences QMS designed to help companies move off paper and disconnected tools and establish a single, scalable system for quality and compliance. Quality teams use Qualio to digitize and automate core processes while ensuring every event, training record, and change is linked to the standards and regulations it supports. Top Features Electronic document & record management Training management with readiness tracking CAPA, deviations, complaints & effectiveness checks Audit scheduling, responses & evidence collection Regulatory mapping and compliance dashboards Design controls support for MedTech & SaMD Integrations & APIs for the broader GxP stack Ideal For Companies preparing for: First ISO 13485 certification First FDA submission or inspection Multi-product or multi-site scale-up Get visibility. Stay compliant. Accelerate safe, successful market entry.