The importance of SW Validation in the CL Industry

April 2022 - Compliance / Software Validation

Ensure regulatory compliance, improve quality management, and validate manufacturing software with structured protocols aligned to ISO standards. Explore validation →

During the EFCLIN Lectures we were invited to describe the concept of Software Validation, the Regulatory Context, its role in a Lab’s own Quality Management System and how Advance Medical has approached its own validation protocol in a pilot project with TS Lac in Italy.

The Protocol has been structured to assist the Manufacturer’s QMS management as referenced in the quality standards of ISO 13485:2016 and it's being implemented in TS Lac, a leading company in the Italian market. The overall project was coordinated by Effetre, a regulatory and quality consultancy company with over 30 years of experience in the field of contactology.

EFFETRE SRL is a company that was founded with the aim of pursuing the development of services related to research, engineering and industrialisation of products, systems and technologies in the field of Medical Device. The company operates internationally since 1987 with absolute autonomy and independence by offering specialised services of quality certification and validation.

The CL Industry is undergoing incredible changes and we as company are constantly working to keep our software in line with the market's requests. We choose to undergo with this challenging project during the COVID outbreak and thanks to the support of our QA Consultant, Ubaldo Fabrizio, and of our partner lab, TS Lac of Italy, we are in the final steps of closing our Software Validation Protocol.

Filippo Selden, CEO Advance