Supporting a PAT Implementation

Support

Expo Technologies' support philosophy begins before a system has been purchased. Our Project Management Approach, for an ePAT device that has already been designed and developed, begins with Applications Feasibility and Implementation Feasibility Studies. These two steps in the project management process facilitate a User Requirement Specification (URS) to be more accurately defined. If it is the client's first time building a URS then Expo can provide template documents.

Once the Functional Design Specification is agreed, the device can be manufactured and tested both at Expo's Technology Center and at the customer site.

Expo Technologies' support philosophy continues in the Sustainability Phase of the project.

Installation:


ExpoTech Installation Philosophy
The installation of the system is a critical step to a successful PAT application. It represents the culmination of a preparatory process that Expo drives to ensure a smooth start-up. This process requires a close partnership and excellent communication between Expo and the client. It is imperative that the installation is well planned and proceeds smoothly - without wasting plant personnel time. Expo has mapped out a comprehensive program that has been proven to be effective.

The scope covers all aspects of the installation, including:

  • A comprehensive Installation Guide detailing the process as drawn up by the IFS.
  • Detailed checklists for the client, to ensure all tasks are completed.
  • A final installation plan based upon completion of the checklist.
  • A site readiness Faxback, sent with the system, for the customer to fax to Expo when all tasks are complete indicating the ideal time(s) for installation.
  • Verification of area classification, environmental conditions, and required certifications.
  • Engineering review of any custom interface issues or other user requirement specifications. Includes mechanical drawings if required.
  • Connections review, including utilities.
  • Overall installation review with customer to ensure all expectations are met.
  • Unlimited phone support during the site readiness process.
  • Copy of acceptance test results to reference against future calibrations.
  • Customer sign-off document verifying complete satisfaction with the installation

Benefits of the Project Management Approach at installation

The benefits include:

  • Assignment of a project engineer to the IFS to installation process.
  • Assurance that the installation and commissioning go smoothly and maximize everyone's time. No one wants surprises or engineering issues to arise that were not contemplated in the original assessment.
  • Increased confidence that the instrument is optimized for performance, immediate usefulness, and return on investment (ROI).
  • The establishment of a technical relationship between Expo field personnel and the customer.

Installation and Operational Qualification service, at installation, is one of the services we are able to provide.

Site Acceptance Test or Installation Qualification (IQ) and Operational Qualification (OQ)

Installation qualification (IQ) is a formal procedure whereby Expo personnel utilize a comprehensive checklist to determine and document the installation of the system. Operational qualification (OQ) is a formal procedure whereby Expo personnel utilize a comprehensive checklist and perform a series of tests to verify and document the operation of the system. The purpose of these procedures is to provide additional, written assurances that the system is optimized for peak performance.

In some cases, these steps may be required by your regulatory department.

The IQ/OQ covers all aspects of the installation and system operation. Specifically, it includes:

  • Configuration information, including software.
  • Documentation list.
  • All appropriate drawings and diagrams.
  • Test procedures and results verifying that the instrument is installed properly.
  • Acceptance criteria.
  • Deviation log and mitigation plan based upon criticality.
  • Calibration information.
  • Appropriate signatures signifying acceptance of the results.

Sustainability Phase - Supporting the PAT once it is installed


ExpoTech Levels of Support
At Expo we believe there are three distinct 'levels' to customer success as shown in the graphic below. Each level is supported by the one below, but the ultimate foundation of success is the teamwork between the customer and Expo. Service and support is the mechanism for maximizing the effectiveness of this teamwork.

Support Overview

  • Feasibility
  • Installation
  • IQ/OQ
  • Service

Site by Intrepid Web Solutions

Copyright 2007-2008 © Expo Technologies. Website