bewest/mdn_qms

repository	folder	title	document_id	authors	approvers	revision	approval_date	effective_date	description
github.com/ehwest/mdn_qms	/	README.md		github.com/ehwest	github.com/bewest	05	2020-08-24	2020-08-24	Medical Data networks Quality Management System

Purpose

This document provides an overview of each element of the Quality Management system used by Medical Data Networks LLC, and in particular, the system supporting the T1Pal software product.

The Quality Management System includes these parts:

Standard Operating Procedures (SOP).

Control of Quality Records

Employee Qualification and Training

Corrective and Preventative Action

Risk and Hazard Management

Compliaint Handling

Medical Device Reporting

Getting access to the software and component services.

Gitflow tailoring used for T1Pal

Semantic Versioning

Configuration Management

Performance Management

Billing Management

Release and Operations Process (docker-compose version)

Release and Operations process (K8s version)

Communication Materials (CM)

Quality Manual

Overall DEV/OPS Software Development Process

Business Associates Agreement

Training Documents

T1Pal Product Definition (PD)

Product Requirements

Intended Use

Verification Methods

Validation Methods

Artifacts of Validation

HIPAA Compliance Statement (how we comply)

Product Development Process (PDP)

Phase 1 -- Research select changes

• Developer gets requirements for the change to be made.

Phase 2 -- Develop

• Cut a new feature branch for that change
• Do development on that branch
• When ready, developer puts it on shared developer branch (DEV)
• Automated testing happens automatically
• Reviewers sign off on changes
• Components go to master branch (refer to gitflow)
• Cut a new release for a new version (refer to semantic versioning)

Phase 3 -- Maintenance Operations

• Fault Management
• Perform Backups of the current system
• system health check
• validate events
• fix or roll back

Phase 4 -- Release changes to production

• Go through a release process to deploy code on servers
• refer to SOP for release
• update SOP as needed

Phase 5 -- Post Market Surveillance

• identification of new features
• identify and triage operations bug fixes

Reference Materials (RM)

Government Identity Information

Security Audit Template

Security Privacy Regulatory Information

Regulatory Support Artifacts (RSA)

FDA Piolicy for Device Software Functions

IMDRF_TECH_151002_sAMD-QMS.pdf

Software As A Medical Device.

Guidance for Industry (part 11, Electronic Records)

21 CFR part 11 Compliance Checklist

Representative Artifacts of the System Design (SD)

Drawings -- including System Architecture and Design

API Specifications

Informative Text

PHASE 3

Phase 2 --

Responsibilities

1. The CEO and VP-level employees are responsible for overseeing and maintaining this standard operating procedure and for assuring that all employees are trained in its requirements.
2. It is the responsibility of all employees, contractors and departments at Medical Data Networks to adhere to this procedure.