When do I need to validate my systems Answer Following Quest

\"When do I need to validate my systems?\" Answer Following Questions briefly:

What and how much to test before we can use the system?

Should we validate standard software functions?

What to tests and document ongoing performance?

Solution

Validation is required whenever your system (be it computer system, equipment, process, or method) is used in a GxP (Good practice for any system) process or used to make decisions about the quality of the product. In addition, if the system is used to generate information for submissions to regulatory bodies like the FDA, the system needs to be validated for correctness.

What and how much to test before we can use the system?

During system validations, Tests Plans or Test Protocols are used to demonstrate that a system meets requirements previously established in specification, design, and configuration documents which are laid out. Test Plans document the general testing strategy; Test Protocols are the actual testing documents.

In software project management, software testing, and software engineering, software verification and validation is made to ensure that a software system meets specifications and that it fulfills its intended purpose.

Barry Boehm, an American software engineer stated these:

Software validation usually uses three specific testing protocols:

Installation Qualifications (IQ)

This verifies that systems on machines are suited to run the software, that the system has been properly installed and that the configuration is correct.

Operational Qualifications (OQ)

This verifies that systems perform as expected.

Performance Qualifications (PQ)

This verifies that systems perform tasks in real-world conditions.

Engineering Validations sometimes use two additional testing protocols:

Factory Acceptance Test (FAT)

This verifies that the equipment meets requirements outlined in the User Requirement Specification or Functional Requirements.

User Acceptance Test (UAT) or Site Acceptance Test (SAT)

This verifies that the item performs as required by the User Requirement Specification or Functional Requirements.