Home > Compliance Software > SimplerQMS
SimplerQMS is a cloud-based QMS software for Life Sciences, supporting FDA, ISO, and EU MDR compliance. It integrates key modules like CAPA, Document Control, and Training, helping regulated companies streamline quality processes with secure Microsoft-based infrastructure.
The Smyte Score is a weighted average from leading review sites across the web.
Comprehensive Compliance Coverage:
Users appreciate that SimplerQMS is fully validated and compliant with major regulatory standards such as FDA 21 CFR Part 11, ISO 13485, EU MDR, and GxP. This ensures that organizations can maintain compliance without additional validation efforts.
User-Friendly Interface:
The platform offers an intuitive interface with seamless integration into Microsoft Office 365, allowing users to work within familiar applications like Word and Excel. This reduces the learning curve and enhances user adoption.
All-Inclusive Subscription Model:
SimplerQMS provides an all-inclusive subscription that covers all modules, implementation, validation, training, hosting, and ongoing support. This transparent pricing model eliminates hidden costs and simplifies budgeting.
Limited Customization Due to Pre-Validation:
Some users have noted that the pre-validated nature of SimplerQMS limits the ability to customize certain features to fit specific company processes. While this ensures compliance, it may restrict flexibility.
Lack of Dedicated Classroom Training Documentation:
Users have reported the absence of a dedicated feature for documenting classroom or on-site training sessions. Although templates can be used, a more automated solution is desired.
Pricing Information Not Publicly Transparent:
While the subscription is all-inclusive, detailed pricing information, especially for the Team & Enterprise plans, is not readily available and requires direct contact with the vendor for a quote.
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