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.
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Frederic Landry
2 min read
Digitizing Clinical Investigations: Why you should read the latest FDA guidance on electronic systems, records, and signatures in clinical trials
FDA updated 21 CFR Part 11 with new guidance using a Q&A format, offering practical advice for electronic records in clinical trials.
Jordane Landry
3 min read
Is a SaaS Vendor Working in the Life Science Industry Required to Comply to All Regulations?
Do SaaS vendors in life sciences need to comply with all regulations? Find out what determines compliance.
Jordane Landry
5 min read
What Software Providers Need to Know: GxP Guidelines and Regulation Framework Overview
This blog explores key global GxP regulatory agencies and their frameworks, extending beyond FDA's 21 CFR Part 11.
Yogesh Patel
6 min read
Using Spreadsheets in GxP Environments 101 - Best Practices and Recommendations
Discover the best practices for using spreadsheets in GxP environments, including validation, categorization, and configuration strategies.
Frederic Landry
4 min read
Why Should You Ban Excel Use in a Regulated Environment?
Ban Excel in regulated industries due to its limitations in data integrity, accuracy, and security, posing compliance risks.
Frederic Landry
5 min read
Why Organizing and Safeguarding Electronic Records Should Be Your First Step Toward Digitalization
Organize and protect electronic records to boost efficiency, ensure compliance, and improve collaboration.
Paula Suliga
5 min read
Differences Between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
Learn about SaMD and SiMD: What they are, how they're regulated, and why they matter for medical devices.
Jonathan Vézina
5 min read
Increasing SaaS Attractiveness Through Regulatory Expertise
Mastering SaaS regulatory requirements in life sciences ensures compliance, boosts product quality, and enhances customer trust.
Frederic Landry
3 min read
Impacts of Centralized and Decentralized Systems on Computer System Validation (CSV)
Explore the impact between centralized versus decentralized system on compliance and data integrity in the life science industry.
Scott McGrail M.Sc. PMP
8 min read
GAMP® 5 Guidelines in Software as a Medical Device Development
Discover how GAMP® 5 guidelines elevate SaMD quality & compliance, ensuring patient safety and data integrity.
Frederic Landry
3 min read
Centralized vs Decentralized Systems - The Impact on Your Business and Decisions
Exploring the impacts of centralized vs decentralized systems on business operations and decision-making.
Frederic Landry
10 min read
Applying a Risk-Based Approach to Records and Data Integrity
Apply a risk-based approach to secure data integrity and ensure compliance.
William Bellavance
5 min read
Anti-blog - Why do my team meetings feel like a high school gym class?
Explore how to transform your recurring meetings into engaging and productive sessions.
Jonathan Vézina
3 min read
Coherence in a Quality Management System - A Game-Changer for Your Company’s Performance
Discover how a structured system reduces misunderstandings in transitions, enhancing transparency as controls tighten.
Jordane Landry
4 min read
6 Life Sciences Conferences a Validation and Compliance Expert Should Consider in 2024
InnovX invites you to discover the 6 events to attend in 2024 if you are a Software Validation Expert.
Jordane Landry
6 min read
Choosing a SaaS Provider in the Life Science Industry – A Closer Look at Data Security and Privacy.
Implementing SaaS solutions in regulated environments. Learn about data security in multi-tenant SaaS and subcontracting impacts.
Myriam Filion
5 min read
Getting Comfortable With Change; The Value of Strategic Change Management
Managing change effectively determines the value we can deliver amidst heightened expectations for speed and effectiveness.
Yogesh Patel
14 min read
Evaluating ChatGPT's Performance: Release of the Score in our Computer System Validation 101 Exam
We recently submitted ChatGPT to our Computer System Validation 101 exam. Did ChatGPT successfully pass our test?
Scott McGrail M.Sc. PMP
5 min read
A Good Foundation: Regulatory Compliance in the Cosmetic Industry
Are you involved with cosmetics and are unsure of your related regulatory requirements? Does hearing about ISO 22716, US FDA 21 CFR Part...
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