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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.

Paula Suliga
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.

Jonathan Vézina
5 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.

Frederic Landry
3 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.

Scott McGrail M.Sc. PMP
8 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
3 min read


Applying a Risk-Based Approach to Records and Data Integrity
Apply a risk-based approach to secure data integrity and ensure compliance.

Frederic Landry
10 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.

William Bellavance
5 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.

Jonathan Vézina
3 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
4 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.

Jordane Landry
6 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.

Myriam Filion
5 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?

Yogesh Patel
14 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...

Scott McGrail M.Sc. PMP
5 min read


12 Software Validation Subjects That Should Be Covered by Your QMS.
One of the primary challenges we encounter when embarking on a CSV (Computerized System Validation) or a QSA (Quality Software Assurance)...

Frederic Landry
3 min read


A Better Experience, What Does It Mean?
This is not a simple question. Much like success, talk to most people and they want to have “it”, but what does “it” mean?

Scott McGrail M.Sc. PMP
6 min read


Food for Thought before Developing Software for the Life Science Industry
If your business is building software for the Life Sciences industry, InnovX can help you do that.

Frederic Landry
3 min read


Updates to Regulatory Guidelines - What's New in ISPE GAMP®5's 2nd Edition?
The new GAMP Guidance is a must-read. Find out what changed and our first impressions of this new edition.

Yogesh Patel
6 min read


What is CFR 21, Part 11 and does it apply to your organization?
In this blog, we explain "Part 11", the reasons that led to the need for this regulation, and the needs for following it.

William Bellavance
5 min read


The value chain in times of pandemic: 3 crucial issues, their risks and mitigation strategies
This blog will present three critical supply chain risks put forward by COVID , as well as their appropriate mitigations

William Bellavance
5 min read


An Integrated View on Business and System Architecture
This blog recaps the key differences and and touch points between entreprise, business and system architecture.

Frederic Landry
4 min read
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