MODA | Paperless Pharmaceutical QC Micro Environmental Monitoring (EM)

Implementation

To ensure the timely and cost effective implementation of your paperless QC Micro solution, MODA offers hands-on implementation and training services. We leverage a Best Practices-Based Delivery Model to remove the risk of deploying our solutions and to help ensure compliance with regulations governing computerized systems within a cGMP environment. This streamlined approach enables an efficient path from installation to acceptance.

Benefits of the MODA Best Practices-Based Implementation Model

The MODA Professional Services organization is comprised of associates with extensive experience in:
•  Faster ROI (Return On Investment)
•  Achieve consistency with industry best practices
•  Minimize cost for implementation services
•  Minimize impact on deployment, training and validation resources
•  Simplify and accelerate validation activities 

Powerful configuration tools with best practices settings

Industry best practices and commonly used regulatory standards are included in a pre-configured platform enabling quick deployment. MODA-EM best practices are based on the vast experience and input from industry analysts, our Board of Advisors, and most importantly, our clients.  This combined with a powerful set of configuration tools enable easy set up and maintenance of client-specific settings for items like site maps, sampling locations, and schedules.

Best practices-based implementation methodology

Our methodology combines the pre-configured best practices platform with a formal training program, hands-on evaluation and support.

Validation support package

Also included is a comprehensive validation documentation package with templates for Master Validation Plan, User/Functional Requirements Specification (UFRS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and scripts, and a Master Validation Summary. Clients accelerate production installation and validation by using this package as a starting point; making modifications to the templates based on their specific processes.

An experienced team

The MODA Professional Services organization is comprised of associates with extensive experience in:
•  Business Case Assessment / Risk Analysis
•  Program Management Project Management
•  Requirements Analysis
•  System Design
•  System Configuration
•  System Integration
•  Computer System Validation
•  Training
•  Support and Maintenance

This experience, combined with our refined delivery model, ensures client success!