About Systera Solutions

Systera Solutions was founded to help life sciences organizations bridge the critical gap between scientific operations, digital systems,
and regulatory compliance.
We specialize in delivering solutions that are not only technically sound, but grounded in scientific reality and designed to meet the highest regulatory standards. Our mission is to support laboratories and clinical teams in building sustainable, audit-ready digital ecosystems that enhance operational efficiency without compromising compliance.

Our Areas of Expertise

Computer System Validation (CSV) and Software Assurance (CSA)

Data Integrity auditing and remediation (ALCOA+, GAMP 5)

Laboratory system configuration and optimization (ELN, LIMS, QMS)

Equipment qualification and lifecycle documentation

Digital transformation strategy and stakeholder alignment.

Who We Are

Systera Solutions is led by Yari Fontebasso, PhD, a scientist and digital systems strategist with over seven years of experience in regulated life science environments. Yari has held leadership roles in R&D IT across biotech and pharmaceutical companies, where he managed system validation efforts, guided digital transformation initiatives, and supported inspections and audits at both the clinical and research level.

Notably, Yari led the development and validation of a GAMP 5 Category 5 script-based application used for clinical assay data analysis in Phase II and III trials. The system supported high-throughput data processing under regulatory oversight and contributed directly to the successful approval of a candidate vaccine.

With a background in molecular biology and clinical assay development, Yari brings a unique perspective to systems design and compliance — one that aligns regulatory expectations with real-world scientific workflows.

How We Work

We believe in practical, collaborative consulting. Our approach emphasizes clear documentation, cross-functional alignment, and sustainable compliance strategies that work across the entire laboratory ecosystem — from equipment qualification and data capture to validation documentation and team training.

We work closely with IT, Quality, and R&D stakeholders to ensure solutions are adopted, understood, and built to last.

Let’s Talk

If you’re implementing a new system, preparing for an inspection, or facing digital complexity in your lab or clinical operations, Systera Solutions is here to help.