Validation

When customers select WebtrialZ to host their pharmaceutical application, the primary goal is to achieve and maintain a validated state for their application.  The WebtrialZ process to implement a new customer application system partners a WebtrialZ project manager with the customer to coordinate all aspects of the Validation process.  

While ultimate responsibility for initial and ongoing management of a validated system is with the customer, WebtrialZ processes and procedures play a large role in the initial startup phases and in the ongoing maintenance of your regulated environment.  Our initial deployment process and ongoing management processes are designed to promote a partnership and strong working relationship with each and every customer.  From initial document preparation and approval through turnover of a system for customer use, WebtrialZ works with each customer to ensure that every detail is addressed and properly documented.  This process enables customers to get systems up-and-running more quickly and with a very high degree of confidence in the quality and reliability of your clinical information system.

Your WebtrialZ hosting services include an initial customer audit of WebtrialZ facilities, documentation, processes and personnel as a part of the WebtrialZ hosting agreement.  This audit is to ensure your entire staff can be confident of the quality and security of the WebtrialZ environment as you deploy and begin to utilize WebtrialZ services.

WebtrialZ deployments include:

	WebtrialZ provided and managed infrastructure implementation project plan
	Infrastructure User Requirements Definition
	Infrastructure Functional Requirements Definition
	Infrastructure Traceability Matrix
	Infrastructure Hardware and Software IQ/OQ Documents
	Infrastructure Implementation Summary Report

WebtrialZ also has a partnership arrangement with a firm specializing in pharmaceutical information system validation to assist customers with specific validation issues or to enhance your existing validation processes.  contact your WebtrialZ sales representative at WebtrialZ@aptconsulting.com for more information.