Off-the-shelf software that you customize using built-in settings (no code writing). This is where 80% of industry pain lives.
Focus on "User Requirement Specifications" (URS) and "Functional Testing." You are essentially proving that the software does what the vendor says it does in your specific environment. Category 4: Configured Products gamp5 category
The benefits of implementing GAMP5 include: gamp5 category
Not all software is created equal. A simple calculator doesn't require the same level of testing as a custom-coded robot arm. GAMP 5 categorizes software into four main groups (numbered 1, 3, 4, and 5) to help quality teams scale their validation activities appropriately. gamp5 category