Subject

Our client, a renowned tobacco company with over 80,000 employees worldwide and headquarters in the USA, needed highly qualified professionals with expertise in validation and qualification in Poland. To address this need, they began searching for a local outsourcing partner specializing in compliance. After thorough research, they discovered eCValidation.

The collaboration began in April 2021 and continues to this day.

Scope

The first project we supported was preparing the client for an FDA audit, as they aimed to enter the U.S. market with Reduced Risk Products.

Our team of consultants participated in the preparations for the certification audit, provided support in conducting the qualification of the equipment, ensured the maintenance of the validated status of devices and systems. In accordance with the decision of central functions, production at the factory located in Poland was terminated. The production lines were removed, including CSV systems, data archiving processes, and the withdrawal of local process instructions.

As a result, the FDA audit was no longer required, and the client canceled the audit. They then assigned our team to new projects where our expertise and support was needed.

We work on a “Time and Material” basis, meaning there’s no fixed project scope. Our team steps in to handle any tasks the client needs, logging hours and detailing what was completed on the project.

Our responsibilities include managing all quality assurance-related tasks, from the qualification of installations (compressed air, water systems, HVAC), through laboratory equipment, temperature and/or relative humidity mapping to CSV validation. We also help with the assessment of change requests, deviations, performing periodic reviews, and issuing proposals and CAPAs.

Our team consists of five people—mainly high-level specialists (one Senior Validation Specialist, Two Professional Validation Specialists, two Junior Validation Specialists).

As part of the tasks performed, our consultants participate in regular meetings to discuss daily operations within the work of the client’s Validation Department.

Results

Thanks to our team’s expertise and attention to detail, the client’s validation requirements are managed with precision, and all assigned tasks are completed efficiently. We consistently provide high-quality documentation, ensuring everything is up to date and meeting regulatory standards. This level of commitment has enabled us to build a lasting relationship with the client, who trusts and relies on us after seeing our skills and reliability in action over the years.

The client sees our team as an extension of their own. Despite being an external partner, we often participate in team-building events outside of working hours. The friendly atmosphere we create, the high-quality documentation we provide, and our flexible approach are appreciated.

The client is very happy with the team we provided and there is no question of ending the cooperation in the near future.