Built Around the Regulations You Are Audited On
Modules are organised around the regulatory processes you are audited on. Audit trails, electronic signatures and tenant isolation are the foundation, not an add-on. MoniDoseQMS is software; you remain responsible for your compliance and validation.
Below: how strongly we support each framework, our validation approach, and data integrity design.
Regulatory Frameworks
Regulations We Build To Support
Modules and templates for each major framework. Self-assessed, not reviewed by a notified body or auditor.
European Union
EU MDR 2017/745
Modules for MDR technical documentation (Annex II/III), post-market surveillance (Articles 83-86), vigilance records (Articles 87-92) and UDI. Self-assessed, not reviewed by a notified body.
Key Modules
United States
FDA QMSR
Built to support the Quality Management System Regulation (21 CFR 820, in force since 2 February 2026), which incorporates ISO 13485 by reference. Covers design controls, production records, CAPA, and management review.
Key Modules
International
ISO 13485:2016
Supports every major ISO 13485 process area, from document control and management review to purchasing, production and measurement. Functions and SOP templates; not a certification of your QMS.
Key Modules
European Union
EU AI Act
Twelve modules for the records of your own AI systems: inventory, risk assessment, conformity assessment, technical documentation, post-market monitoring and more.
Key Modules
United States
21 CFR Part 11
Part 11 controls for electronic records and signatures: audit trail, access control, signature manifestation, password re-authentication. Supported, with open items documented (older signatures carry no content hash; the audit-trail hash chain starts at a documented cut-over).
Key Modules
EU, US, UK
Multi-market registrations
Records for product registrations, UDI and GUDID data, EUDAMED data, economic operators and PRRC. EUDAMED and GUDID are record-keeping modules; submission itself stays manual.
Key Modules
Validation & Data Integrity
Built for Validation in Regulated Environments
Like any eQMS, MoniDoseQMS is validated by you for your intended use. Here is how we support that.
Computer System Validation (CSV)
A GAMP 5-aligned, risk-based approach. We provide a Customer Validation Guide with IQ/OQ/PQ protocol templates (draft, shared under NDA). You validate for your intended use; we support you.
21 CFR Part 11 Controls
How we address Part 11: unique user IDs, signatures with meaning, authority checks, an audit trail of every create, update and delete, record locking after signature, and session controls. Open items: older signatures carry no content hash; the audit-trail hash chain starts at a documented cut-over.
ALCOA+ Data Integrity
Designed to support ALCOA+: records are attributable to a user, timestamped, and kept with before/after history, with a tamper-evident audit trail. Your procedures and validation show that the principles hold in your use.
IQ/OQ/PQ Protocol Templates
Installation, Operational and Performance Qualification templates for your hosted workspace, under NDA with the Customer Validation Guide (draft). Available on all paid plans.
Standards
How strongly we support each standard
Our own scale, from product functions to standards we do not map.
Supported
Functions and templates in the product
Supported, with open items
Open items are tracked openly
Record-keeping modules
Outside the scope of our validation guide
Template-based
Records and SOP templates, no full mapping
Referenced in modules and templates
Mentioned in module fields or templates; no clause-by-clause mapping
Not mapped
No clause-by-clause mapping today
Our Compliance Philosophy
Every change in MoniDoseQMS is audit-trailed. Approvals on controlled records use electronic signatures. Records link across modules for traceability. We do not sell a “compliance add-on”, because these controls belong in the foundation.
See it on your own processes
Book a walkthrough, or map your requirements with the free Regulatory Requirements Finder.