EQMS Implementation | SOLABS | Life Science Industry

Professional Services

SOLABS QM Implementation Plans

From 100% Turnkey to Shared Responsibility

Choose the plan that best fits your needs and budget.



Implementation Activities

QMS Implementation: Project Management
PROJECT MANAGEMENT
Installing and implementing a QMS
INSTALLATION
QMS Implementation: Quality Process Deployment
QUALITY PROCESS DEPLOYMENT
QMS Implementation Training
TRAINING
SOLABS QMS Implementation Data Migration
DATA MIGRATION


Project Management

Turnkey approach with dedicated Project Management including:

  • Project Charter & Project Plan
  • Project Initiation meeting
  • Weekly meetings and minutes
  • Monthly status & budget reports
  • Transition from project-building to support
  • Project closing meeting

Installation

  • Sandbox environment (via Internet) used throughout the implementation project
  • Test, Validation and Production Instances
  • Adlib Server (customized PDF conversion)
  • MS SharePoint and Reporting
  • MS SQL Server
  • IQ Execution

Quality Process Deployment

  • Custom and/or Existing Apps
  • URS/Design Workshops with client for Custom APPS
  • Turnkey or supported Validation approaches
  • Deployed in Sandbox (for the client to confirm the App design meets the requirements)
  • Deployed in Test/Validation and Production environments (for formal qualification)

Training

  • Introduction using sandbox environment
  • Support to project team throughout the project
  • On-site hands-on training to super-users
  • Library of How-To videos

Data Migration

  • Data register templates (for bulk upload of documents and training data)
  • Automated engine (for bulk upload of documents and training data)
  • Turnkey or supported verification approaches

Validation Support

  • We support the validation efforts in-line with a risk-based approach as per GAMP5.


Talk to our expert

Typical SOLABS QM Implementation Plan

General Overview

EQMS Implementation activities: Implementation. Project planning and management. Global validation of the core software. System introduction to project team. Installation and configuration of environments. Data migration activities. Process configuration and validation activities. System interfaces: Definition and implementation. Training activities. Transfer to operation and support. Go Live.