Blogs & Articles

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.

Discover how GAMP® 5 guidelines elevate SaMD quality & compliance, ensuring patient safety and data integrity.

Apply a risk-based approach to secure data integrity and ensure compliance.

InnovX invites you to discover the 6 events to attend in 2024 if you are a Software Validation Expert.

We recently submitted ChatGPT to our Computer System Validation 101 exam. Did ChatGPT successfully pass our test?

Are you involved with cosmetics and are unsure of your related regulatory requirements? Does hearing about ISO 22716, US FDA 21 CFR Part...

One of the primary challenges we encounter when embarking on a CSV (Computerized System Validation) or a QSA (Quality Software Assurance)...

The new GAMP Guidance is a must-read. Find out what changed and our first impressions of this new edition.

In this blog, we explain "Part 11", the reasons that led to the need for this regulation, and the needs for following it.