Validation Documentation


SimplerQMS is a pre-validated Cloud eQMS Solution. This means that you don't need to spend time and money on validation and re-validation, when you use SimplerQMS for managing your quality documentation and records. 

We only require your employees to take part in our training activities, which include Online Group Training, Training Videos, Tutorials and Training User Guides. 

QMS Software Validation Requirements

Validation of Quality Management System Software is a requirement, for any life science company the need to comply with one or more of the standards and regulations:

Watch this video to learn more about the requirements for QMS Software Validation or read about what kind of tools, documents and processes need to be validated.

 

SimplerQMS Validation Document Package

The SimplerQMS Solution is always audit-ready. We deliver a continuously updated validation documentation package, which includes the following documents:

 

Training Certificate

Training record which proves actual users participation in a training activity and training effectiveness

Training Plan

All training activities and planned user participation

Customer Project Definition

Definition of the customer implementation project, scope, deliverables, project team and timing

Project Roles

Definition of person roles (Specified in the project definition) and responsibilities

Master Configuration Definition

Customer decisions on system configuration: Sites, departments, processes, document types, users and roles, templates and documents

Design Report

System settings to be implemented for reaching the objectives

PDF Overlays

Document design chosen by the customer

IQ's

First system vault installation documented: What and when is installed - success or failure. Documentation of Azure Active Directory integration and documentation of system upgrades.

OQ Test Report

Reporting on the OQ test

PQ Test Report

Reporting on the PQ test 

Test Overview

Details on OQ and PQ reports - Success/failure per test case and list of any reported issue

IT Environment Questionnaire

Questionnaire about the current IT environment

IT Environment Report

Recommendations for improvements to the IT environment

Validation Plan

Validation plan for new system releases

Validation Certificate

Validation certificate

Validation Reports

Validation reports for monthly software updates and for new system releases

Risk Management Plan

Risk Management Plan

Risk Assessment and Control

Risk analysis for the SimplerQMS product and for the implementation project

Risk Management Report

Risk management report

Traceability Matrix

Traceability matrix for monthly updates and for new system releases. Documentation between user requirements, IQ, OQ and PQ.

Regulatory Criticality Assessment

Establish if validation and 21 CFR Part 11 compliance is required and why this is the case.

User Requirements Specification

Specification of user requirements - using ISO13485; 21CFR820 and 21CFR part 11

Change Order

Change order controlling changes: New versions; monthly updates and customer implementations.

Functional Specification

Specification of configuration made for covering the user requirements

System Description

Description of system features, supported processes and records created by the system

Minutes of meeting

Minute of meetings from the test and training meetings, go-live approval meeting and formal project closure meeting.

Cut Over Plan

List of action items to execute when the system is released for production. Approval of documents in draft and decommission of the current QMS system. It also includes the executed cut over plan with documentation of completed tasks.

Project End Report

Report that documents the validation and completed project tasks

Sign up for a demo

SimplerQMS - Telephone +45 9390 1614 - Email: info@simplerqms.com