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A Practical Framework for Risk-Based Procurement of GxP Software and Technology Services
Selecting GxP software isn’t just about features—it’s about trust, compliance, and risk. This practical framework helps life sciences organizations evaluate supplier quality, system risk, and validation needs using a structured, risk-based approach to ensure regulatory alignment and business continuity
Frederic Landry
4 min read


10 Essential Life Sciences Regulatory Websites
Stay updated with the latest in the life sciences industry through these top 10 trusted information sources. From regulatory updates by the FDA and EMA to expert insights from The Scientist and Life Science Leader, this curated list helps professionals in biotech, pharma, and clinical research stay compliant, informed, and competitive. Perfect for life sciences experts in North America and Europe seeking reliable, free, and up-to-date content.
Yesmine Ayadi
5 min read


Adapting to the Future of GMP Compliance: Key Takeaways from the PIC/S Guidance on Remote Assessments
The PIC/S Guidance on Remote Assessments, formalizes remote GMP inspections, marking a shift toward digital compliance. With a risk-based approach, clear documentation, and virtual audit readiness now critical, pharmaceutical companies must align their quality systems to meet evolving regulatory expectations. Embracing remote GMP inspections is key to maintaining compliance and gaining a competitive edge.
Yesmine Ayadi
3 min read


Right-Sizing GMP Compliance: Balancing Efficiency, Risk-Based Quality, and Regulatory Expectations in Life SciencesÂ
Rethink GMP: Cut complexity, not quality. Focus on efficient systems that truly improve product quality and patient safety.
Frederic Landry
3 min read


Uncovering CAPEX CRIMES - Ensuring Effective IT Investments
The CRIMES Framework, developed by InnovX, is designed to facilitate a thorough evaluation of potential IT investments across various dimens
Frederic Landry
2 min read


FDA's Draft Guidance for AI-Enabled Medical Devices: Key Insights on Validation Scope, Transparency, and Bias Mitigation
Explores the validation scope outlined in the FDA's guidance, reviews key recommendations, and examines its potential impact.
Jordane Landry
5 min read


2025 Life Sciences Trends – What Can We Do Together
As we approach 2025, QA and validation teams in life sciences must navigate emerging challenges and opportunities to remain compliant.
Jordane Landry
3 min read


2025 Life Sciences Trends – A Perspective for QA and Validation SMEs
Life sciences focus on cybersecurity, AI, and IT alignment in 2025. QA experts lead compliance, innovation, and operational success.
Jordane Landry
6 min read


10 Questions to Ask Before Getting a GxP System
10 essential questions to ask before choosing a GxP system to ensure compliance, reliability, and scalability in life sciences.
Jordane Landry
5 min read
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