Good Automated Manufacturing Practice GAMP

What is Good Automated Manufacturing Practice GAMP?

• Post author:Ramon Cayuela
• Post published:October 26, 2020
• Post category:Computer System Validation CSV
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What the Systems Development Life Cycle (SDLC)?

• Post author:Ramon Cayuela
• Post published:October 26, 2020
• Post category:Computer System Validation CSV
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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
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What is a test script case

What are Test Scripts/Cases?

• Post author:Ramon Cayuela
• Post published:October 22, 2020
• Post category:Computer System Validation CSV/Installation Qualification/Operational Qualification/Performance Qualfication/Validation Engineering
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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
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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
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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
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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
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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
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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
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