Category Archives: Computer System Validation

In Earlier post we understood what is Checklist which useful for Computer System Validation Documents Preparation & Review. Now in this article we are going to understand What is System Deliverable Matrix & Its usage in Computer System Validation? What is Deliverable? A deliverable is any unique and verifiable generated results, or capability to perform a serviceContinue reading “What is System Deliverable Matrix & Its usage in Computer System Validation?”

In Earlier post we understood what is System Release Certificate (SRC) in computer system validation? Now in this article we are going to understand Checklist which useful for Computer System Validation Documents Preparation & Review. The checklist items provide a frame of reference for users and auditors to better determine potential compliance issues with computer systemContinue reading “Final Checklist which made your Computer System Validation Documents Preparation & Review Easy”

In Earlier post we understood What is Validation Master Plan, Its content & Regulatory requirement in Computer system validation? Now in this article we are going to understand what is System Release Certificate (SRC) in computer system validation. What is System Release Certificate (SRC): System Release Certificate (SRC) is authorizes the release of System forContinue reading “What is System Release Certificate (SRC) in computer system validation?”

In Earlier post we understood How to Conduct a GAP Assessment in Computer System Validation process. Now in this article we are going to understand What is Validation Master Plan, Its content & Regulatory requirement in Computer system validation? What is Validation Master Plan? EU GMP Vol. 4 Annex 15 says: “The key elements of aContinue reading “What is Validation Master Plan, Its Content & Regulatory Requirement in Computer System Validation?”

In Earlier post we understood What is Validation Summary Report in Computer system Validation Now in this article we are going to understand How to Conduct a GAP Assessment in Computer System Validation process. What is GAP Assessments? GAP is nothing but difference between actual state and desired state. A way to compare current conditionsContinue reading “How to Conduct a GAP Assessment in Computer System Validation process.”

In Earlier post we understood How to handle Discrepancies during Computer System validation? Now in this article we are going to understand What is Validation Summary Report in Computer system Validation What is Validation Summary Report: Validation Summary Reports provide an overview of the entire validation project. It is summary of all planned activities, their success orContinue reading “What is Validation Summary Report(VSR) in Computer System Validation”

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?”