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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
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
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
8 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.
Frederic Landry
5 min read
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