Screentec Oy is delighted to share a remarkable milestone in the company’s journey. Screentec Oy has earned approval from our esteemed FDA-regulated customer after a successful audit.
This approval marks a significant accomplishment for the company, officially establishing Screentec as a trusted manufacturer of their product. It not only unlocks new opportunities for growth but also reinforces Screentec’s position in the industry.
“The audit result is not only a testament to our commitment to quality but also a significant step forward for Screentec. This achievement positions us as a reliable partner for clients seeking FDA-compliant manufacturing, thereby enhancing our competitiveness in the global marketplace”, says Antti Tauriainen, CEO of Screentec Oy.
Audit readiness of this level does not happen by chance. It is the result of sustained, disciplined effort across multiple functions. Special recognition goes to our exceptional team, whose effort and hard work made this achievement possible: Quality Manager Jaana Kananen, HR and Project Manager Katja Lehtomaa, Process Quality Engineer Hamza Khallok, Process Engineer Jani Sutinen, Quality Assurance Engineer Mia-Maria Kivelä, CTO Mikko Paakkolanvaara, Design Department Manager Jussi Saukko, Production Manager Petri Huhti, and the rest of our dedicated team for their invaluable contributions throughout this process.
Our collective commitment to quality — demonstrated daily through rigorous process discipline, thorough documentation, and a culture of continuous improvement — is what made this approval possible and what will sustain it going forward.
The Role of Verification and Validation in Achieving Compliance
The journey toward FDA regulatory compliance highlights the critical role that Verification and Validation (V&V) plays in ensuring both product quality and regulatory conformance. By carefully verifying and validating our processes, we ensure that the products we manufacture meet regulatory standards — guaranteeing their safety, efficacy, and reliability for end-users. V&V is not a one-time exercise but an ongoing discipline embedded in how Screentec approaches manufacturing at every stage.
For a detailed look at what V&V involves and how it is carried out at Screentec, stay tuned for our next blog post, where we will go deeper into the specific methods and practices that underpin our compliance-ready manufacturing approach.