Effective Validation

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Overview

When one of the most established and iconic brands in the worldwide Consumer Products industry sought to increase sales and expand production, they turned to Avanceon to provide process documentation and validation testing. The customer processes were complex, involving multiple vendors with no FDA experience, but the Avanceon team successfully coordinated and documented the validation to meet the demanding project timeline.

 

The Challenge

The customer – one of the most recognizable global consumer product companies – sought to substantially increase sales and earnings by expanding its popular line of gummy vitamins. To realize this strategically important goal, it developed a new production line involving equipment and software from more than 30 vendors, some of whom had no experience with FDA compliance issues.
 
The customer contracted with Avanceon to define, develop, manage and execute the validation of the complex new system with the key outcome to verify OEM functionality and translate it into validation documentation, essential elements of any FDA-regulated system.
 
The customer also tasked Avanceon with completing the testing and validation without substantially impacting its construction and commissioning schedule: the project had to complete quickly, and the system needed to hit the ground running after we observed and tested its multiple components.
 

 

Analysis

Our initial analysis revealed that much of the code and equipment in the new customer system had been adopted from the candy-making industry, and that most of the OEM vendors had no experience delivering an FDA-approved solution. This required that we spend significant time with the OEM vendors – some of them in Europe and Australia – to mine the information necessary to develop their documentation and compliance packages and ensure our customer received equipment and processes that met FDA requirements.
 
We also determined that we could move the project along quickly by adapting standard Avanceon documentation templates based on GAMP5 (Good Automated Manufacturing Practice, iteration 5) for some of the system processes.
 

 

The Avanceon Solution

Working with design specifications provided us by the OEM vendors, we wrote validation documents and traceability matrixes that linked user requirements to Factory Acceptance Tests (FAT), Site Acceptance tests (SAT), Installation Qualifications (IQ), and Operational Qualifications (OQ) .
 
For the balance of the system, we based the documentation on our standard templates, thus leveraging the results of initial testing and eliminating double-testing. This saved considerable time.
 
After completing the initial documents, we worked with the customer to determine which testing points required multiple tests and what that testing would entail and carried out the testing successfully.
 
As the project came to a close, we worked with the customer as a quality control resource to ensure satisfactory deviation resolution and ensure that all OEMs provided components matching the initial requirements, design documents, and protocols.
 

 

The Team

The Avanceon team included more than ten personnel resources over the eighteen-month project, scaled based on production support requirements and installation timing. We worked side-by-side with the customer to meet the aggressive project timeline and with the OEM providers to guide them through the rigorous and unfamiliar validation process.
 
We harnessed our ability to work on multiple global sites and our flexibility to work around the customer’s production schedule – working on off hours to ensure adherence to the project timeline.
 

 

Result

The project completed on time allowing the customer to deploy the new system with complete confidence. This sizeable project also demonstrated the Avanceon team’s ability to develop validation and compliance design documents that transfer effectively to FAT, SAT and IOQ while emphasizing efficiency and reuse throughout each phase of a project.
 
 

 
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