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Siri Comply
One controlled system for the work regulators ask about.
Siri Comply is our configurable quality management platform for medical device manufacturers: documents, records and workflows that regulators around the world expect, in one place.
Overview
One controlled system for the work regulators ask about
Built around 21 CFR Part 11 expectations, with electronic signatures, audit trail and role-based access as defaults rather than options.
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Capabilities
What it automates
Document Control
Controlled documents with versioning, review cycles and training links.
CAPA Management
Investigation, root cause, action tracking and effectiveness checks in one record.
Non-Conformance
NC reporting and disposition with the evidence attached.
Complaints & PMS
Complaint intake, assessment and reportability decisions with an audit trail.
Who Siri Comply is for
Siri Comply is aimed at medical device and diagnostics manufacturers that have outgrown spreadsheets, shared drives and paper sign-off, but do not want to run a large enterprise quality suite. The goal is simple: the records an auditor or notified body asks for should live in one controlled place, with a clear history of who did what and when.
The requirements it is designed around
- 21 CFR Part 11 for electronic records and signatures: unique user accounts, signature manifestation, and a secure, time-stamped audit trail.
- The FDA Quality Management System Regulation, which since 2 February 2026 incorporates ISO 13485:2016 by reference into 21 CFR Part 820.
- ISO 13485 expectations for document control, records, CAPA, nonconforming product and complaint handling.
- EU MDR and IVDR quality system obligations for manufacturers placing devices on the European market.
Why one system matters
Quality processes are connected. A complaint can trigger an investigation, the investigation can raise a CAPA, the CAPA can change a procedure, and the changed procedure needs training records behind it. When those steps sit in separate tools, the links between them are where audit findings appear. Keeping them in one system makes the trail easy to follow and easy to show.
Validation support
A quality system is itself a computerised system that must be validated for its intended use. Our computer system validation team can support that work, from requirements and risk assessment through to test execution and the summary report.
If you would like to discuss whether Siri Comply fits your processes, talk to a specialist.
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