Software Validation for Regulatory Compliance
 "We were delighted with Gael's support during our validation efforts, and due to their excellent and prompt customer support, the quick time to address issues allowed us to resolve test script deviations found during testing. As a result of this, we have not only saved time and money, but are well on the way to achieving regulatory compliance with the FDA."Melissa Makowiec, Director of Quality, Vibrynt Inc |
Validating software 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?
We can assist and support you throughout your validation process by providing the tools and information you require to guide you through the validation minefield.
Gael's Validation Project Management service includes 2 days on-site consultation with a Project Manager to help you gain a basic understanding of the validation process. While on-site, the Project Manager will go through the documents provided and discuss with you what else will be required for you to successfully complete the validation.
You will be provided with the following generic 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 application
- 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 application
Find out more about our Validation Services for Healthcare and Life Science companies.
Alternatively, contact us now to find out how Gael can help and support you throughout your validation process to help you achieve compliance with key regulatory requirements.
