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 conditions & practices in order to identify gaps and areas in need of improvement with regards to compliance to the relevant standards. It   is the procedure to manage an organization to not only correct or improve their processes, but also identify processes which are in necessity of upgrade. Gap Assessment is one of the best procedures to help lead an organization to not only improve their processes, but recognize which processes are in need of improvement. The aim of GAP Assessment in  Computer System Validation  is to identify the gap between company’s existing procedures, practices and policies with respect t...

  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 Validation Summary Reports provide an overview of the entire validation project. It is summary of all planned activities, their success or failure, and any deviations from the expected results or plans encountered. Once the summary report is signed, the validation project is considered to be complete. When regulatory auditors review validation projects, they typically begin by reviewing the summary report. Data Integrity App When validation projects use multiple testing systems, some organizations will produce a testing summary report for each test protocol, then summarize the project with a final Summary Report. The purpose of a Validation Summary Report (VSR) is to provide a concise overview of the entire validation effort and the results obtained. Additiona...

  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, defect, deviation, out-of specification, out-of-limit, out-of-trend Data Integrity App Discrepancy Form: It is form on which any discrepancy observed during computer system validation process has been recorded. Quality Assurance Team shall issue the Discrepancy form & assign unique number to each Discrepancy & maintained log for the same. Discrepancy Form must include : •       Discrepancy Details, •       Type of Discrepancy, •       Severity of Discrepancy, •  ...

  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? Qualification Qualification is defined as an action of providing that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results   It is the process used to establish confidence that the equipment is capable of consistently operating within established limits and tolerances.   Need of Qualification •   To manufactured a quality product •   Proof “suitability for intended use” •   Regulatory requirements •   Cost effective Qualification Protocols: Qualification protocols are methods for demonstrating that equipment being used or installed will offer a high degree of ...