What is Computer System Validation (CSV)?
The concept of computer system validation consists of two (2) terms: software validation and hardware validation.
FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.” Read more information.
When is Required a Computer System Validation CSV?
The CSV is required whenever software is used to design, develop, or manufacture medical devices, pharmaceuticals, or GMP products. Read more information.
The Top ten (10) Computer System Validation Deliverables
Determine the validation deliverable and testing requirements based on the application category risk value, for each application functionality. Read more information.
What is the Design Qualification?
The design qualification is a set of documents intended to demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS) by the end-user or client. Read more information.
What is the Requirement Document URS?
A requirement can be any need or expectation for a system or for its software. Read more information.
What is the Specification Document FRS?
A specification is defined as “a document that states requirements.” (See 21 CFR §820.3(y).) It may refer to or include drawings, patterns, or other relevant documents and usually indicates the means and the criteria whereby conformity with the requirement can be checked. Read more information.
What is the Software Confidence Level?
Software validation is difficult because testing can be forever, and it is hard to know how much evidence is enough. Therefore, software validation is a matter of developing a “level of confidence” that the device or system meets all requirements and user expectations for the software automated functions and features of the device. Read more information.
What is a GAMP Software Risk Category?
In computer system validation, risk Analysis criteria of errors or faults applicable in a particular category of software application functionality are described as low, middle-low, moderate, and high. Read more information.
What is a GAMP Risk Categories of Hardware?
Hardware Category 1 – Standard Hardware Components- low risk
The majority of the hardware used by regulated companies will fall into this category.
Hardware Category 2 – Custom Built Hardware Components – high risk
Custom items of hardware should have a Design Specification (DS) and be subjected to acceptance testing. Read more information.
What is a Risk-Based Validation Approach – Priority Level?
A risk-based validation approach for each functional category can be established once the risk assessments for individual functional items from the URS have been determined as high, medium, and low. Read more information.
What Types of Testing Exist?
The types of testing that should be considered when developing the test strategy are White Box Testing and Black Box Testing. Read more information.
What are Test Scripts/Cases?
Test scripts should contain the details of the tests. The test script should be described in sufficient detail to enable the consistent repetition of the test. Read more information
How Many Test Environments Exist?
The test strategy should consider and define the scenario required for testing. Testing may take place in different environments or locations during a project, which may include: the development environment, testing environment, and operational environment. Read more information.
How to Prepare a Computer System Validation Protocol?
The CSV protocol may include some common sections and information, (as applicable). Read more information