Q-Pulse Validation

Validating software is required in heavily regulated industries, such as healthcare and life sciences. It can be difficult and time consuming, and many companies find the process of validating a system considerably more complicated than implementing the software system itself.

Managing your validation process with the minimum amount of resources and maximum amount of efficiency is the simplest way for regulatory compliance to be achieved.

How can Gael help?

Gael provides initial guidance and documentation on how to proceed with your validation, significantly reducing the effort required by you and saving your organisation weeks, if not not months, in their overall validation process.

The Validation Support service includes two days on-site consultation with one of Gael's consultants to help you gain a basic understanding of the validation process while providing you with the information required to complete the software validation.

You will be provided with the following documentation templates for the validation process, developed in conjunction with ECL2 Consulting Services LLC: 

• Configuration Map (which will be used to develop the URS)

• Gael Validation Support Documents (providing its customers with the assurance that the product has been developed with the appropriate controls in place to produce a consistent, quality application)

• Validation Master Plan

• Detailed Design Specification

• Validation Summary Report

While on-site, the Project Manager will assist you in the development of the User Requirements Specification (URS) that will be the basis for developing your Performance Qualification Protocol.

ECL2 Consulting Services LLC is Gael's preferred service provider in the U.S. for validation services. They provide comprehensive validation services and can assist your organisation in completing the entire process.

How will my organisation benefit from Gael's validation service?

• Provision of generic document templates specifically for the Q-Pulse solution
• Hands-on assistance from a Project Manager to explain the process and help get you started
• Reduction of the time and cost of validation activities in working with a Project Manager familiar with the Q-Pulse solution
• Allows you to focus on what is important to you and your Q-Pulse configuration

Contact us now at info@gaelquality.com to find out how Gael can help and support you throughout your validation process, helping you achieve compliance with key regulatory requirements.