How many test environment exists?

3 Typical Test Environments in System Development Life Cycle (SDLC)

• Post author:Ramon Cayuela
• Post published:October 24, 2020
• Post category:Computer System Validation CSV/Design Qualification/Installation Qualification/Operational Qualification/Performance Qualfication/URS User Requirement Specifications/Validation Engineering/Validation Plan
• Post comments:0 Comments

Select the appropriate test environments for computer system validation CSV according to GAMP5. For more tips and tools, follow us.

Continue Reading3 Typical Test Environments in System Development Life Cycle (SDLC)

Which type of testing is better

Which Type of Testing is Better?

• Post author:Ramon Cayuela
• Post published:October 22, 2020
• Post category:Computer System Validation CSV/Design Qualification/Operational Qualification/Performance Qualfication/Validation Engineering/Validation Plan
• Post comments:1 Comment

Learn what is a white box & black box type of testing in computer system validation CSV. For more tips & download templates, follow us

Continue ReadingWhich Type of Testing is Better?

What is Risk-Based Validation Approach

What is a Risk-Based Validation Approach – Priority Level?

• Post author:Ramon Cayuela
• Post published:October 22, 2020
• Post category:Computer System Validation CSV/Design Qualification/Risk Analysis/Risk Management/Validation Engineering
• Post comments:0 Comments

How to perform a computer system validation CSV using a risk-based validation approach. For more tips & download templates, follow us

Continue ReadingWhat is a Risk-Based Validation Approach – Priority Level?

GAMP Hardware Risk Category

How to determine the GAMP Hardware Risk Category?

• Post author:Ramon Cayuela
• Post published:October 22, 2020
• Post category:Computer System Validation CSV/Design Qualification/Risk Analysis/Risk Management/Validation Engineering
• Post comments:0 Comments

Learn how to determine the Software Risk Category according to GAMP5. For more tips & download validation protocol templates, follow us.

Continue ReadingHow to determine the GAMP Hardware Risk Category?

what is GAMP software risk category

What is a GAMP Software Risk Category?

• Post author:Ramon Cayuela
• Post published:October 21, 2020
• Post category:Computer System Validation CSV/Design Qualification/Risk Analysis/Risk Management/Validation Engineering
• Post comments:0 Comments

Learn how to determine the Software Risk Category according to GAMP5. For more tips & download validation protocol templates, follow us.

Continue ReadingWhat is a GAMP Software Risk Category?

Software level of confidence

What is the Software Confidence Level?

• Post author:Ramon Cayuela
• Post published:October 21, 2020
• Post category:Computer System Validation CSV/Design Qualification/Risk Analysis/Risk Management/Validation Engineering
• Post comments:0 Comments

How to determine the software confidence level & risk during computer system validation CSV. For more tips & download templates, follow us.

Continue ReadingWhat is the Software Confidence Level?

What is design qualification

What is the Design Qualification?

• Post author:Ramon Cayuela
• Post published:October 21, 2020
• Post category:Computer System Validation CSV/Design Qualification/Validation Engineering
• Post comments:1 Comment

Learn more about the requirements & specifications related to a design qualification. For more info, tips & download templates, follow us.

Continue ReadingWhat is the Design Qualification?

All you need to know about computer system validation CSV

All You Need to Know About Computer System Validation CSV

• Post author:Ramon Cayuela
• Post published:October 20, 2020
• Post category:Computer System Validation CSV/Design Qualification
• Post comments:0 Comments

Learn how to perform a computer system validation CSV according to GAMP5 & 21 CFR Part 11. For more tips & download templates, follow us

Continue ReadingAll You Need to Know About Computer System Validation CSV

Hipster businessman showing concept of online business security on virtual screen

How to build a Functional Requirement Specifications FRS.

• Post author:Ramon Cayuela
• Post published:September 30, 2020
• Post category:Design Qualification/FRS Functional Requirement Specification/Validation Engineering/Validation Plan
• Post comments:1 Comment

The Functional Requirement Specifications FRS describes the software product to be implemented in terms of the functions it will perform and the facilities required to meet the user requirements specifications.

Continue ReadingHow to build a Functional Requirement Specifications FRS.

CIQA Design Qualification

When is Required a Design Qualification?

• Post author:Ramon Cayuela
• Post published:September 30, 2020
• Post category:Design Qualification/Validation Engineering
• Post comments:2 Comments

What is the design qualification? How to create a design qualification before the next FDA inspection? Learn more & download a free sample here

Continue ReadingWhen is Required a Design Qualification?