Author Archives: Innovative Appz

In Earlier post we understood What is Qualification protocol (IQ/OQ/PQ/IFQP), Its Necessity & When requalification performed in CSV? Computer system validation? Now in this article we are going to understand How to handle Discrepancies during Computer System validation? What is Discrepancy? Datum or result outside of the expected range; an unfulfilled requirement; may be called nonconformity,Continue reading “How to handle Discrepancies during Computer System validation?”

In Earlier post we understood what is Software Code Review & Its Checklist to review source code in Computer system validation? Now in this article we are going to understand What is Qualification Protocol (IQ/OQ/PQ/IFQP), Its Necessity & When requalification performed in CSV? Computer system validation? What is Qualification? Qualification is defined as an actionContinue reading “What is Qualification Protocol (IQ/OQ/PQ/IFQP), Its Necessity & When re-qualification performed in CSV?”

In Earlier post we understood What is Configuration Specification, Its Roles & Elements in Computer system Validation. Now in this article we are going to understand What is Traceability Matrix, Its Use, & Benefits   in Computer system Validation. What is Traceability Matrix? (TM) A TM is a document that co-relates any two-baseline documents that requireContinue reading “What is RTM & Its importance in CSV?”

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”