What is Risk-Based Validation Approach
What is a Risk-Based Validation Approach – Priority Level?
How to perform a computer system validation CSV using a risk-based validation approach. For more tips & download templates, follow us
Validation engineering topics: Installation Qualification, Operational Qualification, and Performance Qualification
GAMP Hardware Risk Category
How to determine the GAMP Hardware Risk Category?
Learn how to determine the Software Risk Category according to GAMP5. For more tips & download validation protocol templates, follow us.
what is GAMP software risk category
What is a GAMP Software Risk Category?
Learn how to determine the Software Risk Category according to GAMP5. For more tips & download validation protocol templates, follow us.
Software level of confidence
What is the Software Confidence Level?
How to determine the software confidence level & risk during computer system validation CSV. For more tips & download templates, follow us.
What is design qualification
What is the Design Qualification?
Learn more about the requirements & specifications related to a design qualification. For more info, tips & download templates, follow us.
The Top 10 Computer System Validation Deliverables
The Top 10 Computer System Validation Deliverables
The computer system validation deliverables required as per FDA and 21 CFR Part 11. For more tips & download protocol templates, follow us
When is Required a Computer System Validation CSV
When is Required a Computer System Validation CSV?
Determine when is required a computer system validation CSV according to FDA & 21 CFR Part 11. For more tips & download templates, follow us
What is software validation 900x 600
What is Software Validation?
Learn what is a software validation according to the FDA, 21 CFR Part 11 and GAMP5. For more tips & download templates, follow us
All you need to know about computer system validation CSV
All You Need to Know About Computer System Validation CSV
Learn how to perform a computer system validation CSV according to GAMP5 & 21 CFR Part 11. For more tips & download templates, follow us
Analytical Test Methods Categories
Analytical Test Method Categories
The USP 1225 analytical test method categories most commonly used are Category I, II, III & IV. Download protocol templates. Get tips & more.
