Category Archives: Computer System Validation

In Earlier post we understood what is project validation plan (PVP) & What Content should include in PVP? Now in this article we are going to understand What is Configuration Specification, Its Roles & Elements in Computer system Validation. What is Configuration Specification (CS)? The Configuration Specification details the configuration parameters & how these settingsContinue reading “What is Configuration Specifications in Computer system validation?”

In Earlier post we understood What is Design Specification, Its Type & Elements in Computer System Validation. Now in this article we are going to understand What is project validation plan(PVP) & What Content should include in PVP?. What is Project Validation Plan(PVP): CSV processes should be guided by a good plan that is createdContinue reading “What is Project Validation Plan (PVP) in Computer System Validation?”

In Earlier post we understand Function Requirement Specification (FRS) & Its Checklist that should followed while finalizing FRS. Now in this article we are going to understand What is Design Specification, Its Type & Elements in Computer System Validation. The Design Specification (DS) describes the hardware and software platforms of your system to be validated.Continue reading “What is Design Specification, Its Type & Elements in Computer System Validation?”

In Earlier post we understand User Requirement Specification & Its Guidelines should be kept in mind while finalizing URS in computer system validation. Now in this article we are going to understand Function Requirement Specification (FRS) & Its Checklist that should followed while finalizing FRS. User Requirements describe the end-user requirements for a system. FunctionalContinue reading “What is Functional Requirements Specifications (FRS) & Checklist that should followed while finalizing FRS”

URS provide the knowledge of basic user requirements to manufacturer / supplier about equipment / utility / facility proposed to be procured by the user. The URS is then provided to the manufacturer/Supplier as an input for the quotation, design, construction, commissioning and validation of the system. URS should clearly & precisely define what theContinue reading “Guidelines should be kept in mind while finalizing User Requirement Specification”

In Earlier post we understand GxP Assessment & Categorization of Computerized System. It is first stage of whether a system requires a validation is to identify whether the system has a GxP impact. Now in this article we are going to understand System Level Risk, Impact & Complexity Assessment in computer system validation. Applying riskContinue reading “System Level Risk, Impact & Complexity Assessment in CSV”

In Earlier post we understand what steps which should be executed during computer system Validation activity. These steps will helpful to understand how CSV will be performed. Now in this article we are going to understand GxP Assessment & Categorization of Computerized System. It is first stage of whether a system requires a validation isContinue reading “GxP Assessment & Categorization of Computerized System”

In Earlier post we understand what is Computer System Validation (CSV), Why CSV Required, Purpose of CSV & Benefits of CSV. Now in this article we are going to understand steps which should be executed during computer system Validation activity. These steps will helpful to understand how CSV will be performed. Each & every stepsContinue reading “Steps should be executed for performing Computer System Validation”

History of CSV: The concept of validation was derived from engineering principles of validation of mechanical system that has been extended to the software industry. To extend it further during mid-1970’s, Ted Byers and Bud Loftus, two Food and Drug Administration (FDA) officials first proposed the concept of validation in order to   improve theContinue reading “What is CSV, Its Need, Purpose & Benefits in pharma Industry.”