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
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.
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.
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...
Frederic Landry
3 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)...
Yogesh Patel
6 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.
William Bellavance
5 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.
Frederic Landry
8 min read
Regulations you must know before selecting an ERP system
identifies GCP, GMP and Med Devices regs you must consider when devising an ERP validation strategy.
Frederic Landry
5 min read
5 Common Mistakes in ERP Validation
ERP systems are critical and complex applications. Here are 5 mistakes you should avoid when validating them.
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