On June 9th, SoftExpert hosted an Italian-language webinar dedicated to non-conformance management and CAPA processes, a topic of great importance for companies operating under strict regulatory requirements. The event, held online, featured the presence of Laiz Del Moro, Country Manager of SoftExpert Italy, and Giulio Massarutto, Quality and Compliance Director at MW.FEP.
The problem that doesn't disappear with documentation
The central question of the webinar started from a concrete point: why do non-conformances keep repeating even in organizations with well-documented processes?
The answer, developed throughout the webinar by the expert speakers, did not point to isolated technical failures, but to the lack of real traceability, the lack of integration between recording processes and corrective actions, and the limitations of manual control methods. In other words, documenting is not the same as tracking, and recording is not the same as acting; therefore, most recurring problems do not live in the process itself, but in the gap between recording the occurrence and the action that should have closed the loop.
The MW.FEP case
This is where the discussion moved from abstract to practical. In his presentation on the MW.FEP case study, Giulio Massarutto showed how the company needs to simultaneously meet requirements such as ISO 13485 and AS9100, with occurrences distributed across different production areas. Before adopting SoftExpert Suite, control was managed using parallel spreadsheets, which worked until an audit showed that the practice was already outdated and, in fact, ineffective.
However, with the Suite platform, the recording of non-conformances, approval workflows, and corrective actions began to operate in an integrated manner. Massarutto was specific about the impact: the quality team stopped wasting time consolidating dispersed information and gained access to an auditable history available in real time. And for a frequently audited company, this is what determines whether an audit ends in compliance or with the opening of new records.
What technology solves
In her presentation, Laiz Del Moro demonstrated the unique ability of SoftExpert Suite to go beyond solving quality issues: the tool also removes the administrative hurdles that prevent people from solving them.
According to Del Moro, the software's innovative technology is what makes this possible, since its system connects the NC, CAPA, audit, and workflow modules within a single database.
The webinar was part of SoftExpert's initiative to provide the audience with technical content aimed at those already familiar with the subject. Less introduction to the topic, more benchmarks from those who have experienced the problem firsthand.
