5 May, 2026
AI in Qualification & Validation: The Real Challenge Is Trust
Artificial Intelligence is rapidly entering pharmaceutical and biotech environments, including Qualification & Validation activities.
Yet in GxP environments, the real challenge is not simply technological.
It is about governance, explainability, data integrity, lifecycle management, and regulatory defensibility.
At GXP Consulting Switzerland, we recently developed an in-depth analysis exploring how AI is beginning to reshape Qualification & Validation practices, from process monitoring and audit trail review to AI-assisted documentation and risk-based validation strategies.
16 April, 2026
Thermal Mapping: Beyond Compliance
A critical requirement for temperature-sensitive products
Ensuring proper storage conditions for temperature-sensitive products is essential in regulated environments such as pharmaceuticals and biotechnology.
Temperature deviations can lead to:
Reduced drug efficacy
Product degradation
Compromised analytical results
Maintaining controlled and homogeneous conditions is therefore not only a regulatory expectation, but a key factor in product quality and patient safety.
24 March, 2026
OQ challenges often originate earlier: a focus on Installation Qualification
In pharmaceutical GMP projects, issues identified during Operational Qualification (OQ) rarely originate at that stage.
They are often the consequence of gaps introduced earlier, during Installation Qualification (IQ).
IQ is not a formal checkpoint. It is a critical phase where the installed system is verified against design documentation, and where traceability, documentation, and system integrity are established. When inconsistencies remain at this stage, they tend to surface later, under tighter timelines and increased operational pressure.
Across utility systems such as purified water, clean steam, compressed air, and HVAC, several recurring points of attention can be observed.
17 February, 2026
Opening a New Chapter at Biopôle Lausanne
Opening a New Chapter at Biopôle Lausanne
We are proud to announce our new presence at Biopôle Lausanne, one of Europe’s leading life sciences campuses.
This milestone comes at a particularly meaningful time as we celebrate our 12th anniversary, marking more than a decade of supporting life sciences organizations across Switzerland and beyond.
