Blogs & Articles

Software validation is essential in life sciences to ensure compliance, data integrity, and patient safety. Guided by GAMP 5 and FDA CSA, modern validation uses risk-based methods to verify that systems like SaMD, LIMS, QMS, and MES perform reliably. By applying critical thinking, strong supplier oversight, and lifecycle monitoring, organizations can meet FDA and EU requirements while improving quality and operational efficiency

ERP systems are essential for Life Sciences companies seeking compliance and efficiency. A Life Sciences ERP must ensure GxP validation, integrate Quality Management (QMS), enable full traceability, and support audit readiness. Scalable, modular, and validation-ready ERPs enhance data integrity, regulatory compliance, and patient safety. Learn how to choose the right ERP for your Life Sciences organization with InnovX.

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

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.

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.

Rethink GMP: Cut complexity, not quality. Focus on efficient systems that truly improve product quality and patient safety.

The CRIMES Framework, developed by InnovX, is designed to facilitate a thorough evaluation of potential IT investments across various dimens

Explores the validation scope outlined in the FDA's guidance, reviews key recommendations, and examines its potential impact.

As we approach 2025, QA and validation teams in life sciences must navigate emerging challenges and opportunities to remain compliant.

Life sciences focus on cybersecurity, AI, and IT alignment in 2025. QA experts lead compliance, innovation, and operational success.

10 essential questions to ask before choosing a GxP system to ensure compliance, reliability, and scalability in life sciences.

FDA updated 21 CFR Part 11 with new guidance using a Q&A format, offering practical advice for electronic records in clinical trials.

Do SaaS vendors in life sciences need to comply with all regulations? Find out what determines compliance.

This blog explores key global GxP regulatory agencies and their frameworks, extending beyond FDA's 21 CFR Part 11.

Discover the best practices for using spreadsheets in GxP environments, including validation, categorization, and configuration strategies.

Ban Excel in regulated industries due to its limitations in data integrity, accuracy, and security, posing compliance risks.

Organize and protect electronic records to boost efficiency, ensure compliance, and improve collaboration.

Learn about SaMD and SiMD: What they are, how they're regulated, and why they matter for medical devices.

Mastering SaaS regulatory requirements in life sciences ensures compliance, boosts product quality, and enhances customer trust.

Explore the impact between centralized versus decentralized system on compliance and data integrity in the life science industry.