About SequenceQMS

SequenceQMS is an electronic quality management system for medical device companies. It holds the records a device company is required to keep - controlled documents, change orders, CAPAs and nonconformances, design history, risk files, training, supplier qualification, equipment calibration - and it holds them in a form that stands up to an FDA inspection or an ISO 13485 audit.

Why we built it

Most quality systems are either a filing cabinet with a login, or an enterprise platform that needs a consultant to operate. Both push the same cost onto the same people: quality and regulatory staff spend their time feeding the system instead of doing the work the system exists to evidence.

We built SequenceQMS on one principle: a person who is not a quality professional should be able to open it and understand what is being asked of them. Plain language, one obvious next action, and the compliance machinery running underneath rather than in your face.

How we hold ourselves to it

SequenceQMS is itself developed under a quality system. The product's own design history file, software requirements, design specification, and verification and validation records are controlled records maintained alongside the source code. Every release runs a full verification suite before it ships, and every production deployment is recorded in a release control record. We hold the software to the standard we ask our customers to meet.

What it is aligned to

• FDA 21 CFR Part 11 - electronic records and electronic signatures
• FDA 21 CFR Part 820 - Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016
• ISO 13485:2016 - medical device quality management systems
• ISO 14971:2019 - risk management for medical devices
• IEC 62304 - medical device software lifecycle

Contact

Sequence Group, LLC - info@sequencemedtech.com