Designed on
DocQMS Regulado: the document QMS built by a regulatory specialist
A multi-tenant platform to manage your document quality system with end-to-end traceability, designed on the requirements of ISO 13485, 21 CFR Part 11 and Part 820, EU MDR and ANMAT.
- ISO 13485
- 21 CFR Part 11
- 21 CFR Part 820 / QMSR
- EU MDR
- ANMAT
- ANVISA
Not a generic document manager
Most QMS tools are built by software people who learn the regulation as they go. DocQMS Regulado was built the other way around: from regulatory judgment toward the code. Every flow (document approval, electronic signature, change control, risk management) is designed to withstand an audit, because it was designed by someone who accompanies those audits.
What it includes
- Document control with traceabilityVersioning, approval, electronic signature and a hash-chained audit trail.
- CAPA, nonconformities and change controlQuality flows linked to one another: a major NC opens its CAPA, closing the CAPA updates the risk.
- ISO 14971 risk managementRisk files with configurable methodology (probability, severity, matrix) linked to product design.
- Design and device recordsDesign control (DHF), Device Master Record and Device History Record for Part 820.
- Scope by jurisdictionSpecific modules for ANMAT, FDA and EU MDR, enabled according to each customer’s regulatory scope.
- Plans by scopeEssential, Business and MedTech tiers: each customer activates the modules their contract requires.
Why with Warscher Consulting
- Built and maintained by the people who do the regulatory work.The platform embodies judgment; it is not an empty box you have to configure blind.
- Multi-jurisdiction scope.The same system accompanies your product in Argentina, the United States and the European Union.
- Documented readiness.21 CFR Part 11 readiness posture and internal technical validation documentation (IQ/OQ/PQ) available.
- The tool and the judgment, together.The platform operates; the consultancy designs, validates and implements. You do not buy orphan software.
How it fits with the consultancy
DocQMS Regulado is the operational backbone of your quality system. Warscher Consulting’s services (ISO 13485 implementation, risk management, registration and compliance) design and validate that system; the platform sustains it day to day. They can be contracted separately or together.
Frequently asked questions
Is the platform certified to 21 CFR Part 11 or ISO 13485?
No, and it is worth being clear: no software “certifies” Part 11 or ISO 13485 on its own. Those standards apply to your organization and your use of the system. DocQMS Regulado is designed on those requirements, with a readiness posture and internal technical validation documentation available for your validation process.
What happens with my data?
The platform is multi-tenant with per-customer isolation, role-based access control and backups. The service agreement and the data processing agreement (DPA) are available for review.
Can I try it before committing?
Yes. We work with a scoped pilot scheme, with roles, procedure adoption and validation support (IQ/OQ/PQ) during the trial.
Does it replace ISO 13485 certification?
No: it supports it. Certification is granted by an accredited body over your system; the platform helps you operate it and arrive at the audit with traceability.
Request a demo and let’s look at your case
Or let’s discuss a scoped pilot, with roles, procedure adoption and validation support during the trial.