I am looking for an experienced Software Validation / Computerized System Validation (CSV) freelancer to support a validation project for a software system used in a regulated environment (healthcare / medical / life sciences).I need someone who has prov

@hareshfinadiya

Hi, I am Haresh, having 14+ years of experience in Software Testing Industry. - Having unique blend of knowledge in Quality Product Delivery, Processes Management, Functional testing, Integration and regression testing, load and Perfromance Testing which help me to take the Quality of the software to the next level. - Hands on experience on testing Desktop, Web Based, Mobile application and ERP based application. - Hands on experience on automation testing tools on selenium webdriver, jmeter, katalon studio, Appium, cypress, selenium with TestNG freamwork etc.. - Thorough understanding of Product Delivery Life Cycle, Software Testing Life Cycle and Software Development Life Cycle. - Experience in Well conversant with writing Test plan,Test Cases,Bug report, Release Note and Product Health Report. - Worked in various domains like Finance, Retail, Web Portals, Healthcare, ecommnerce, CMS, Eduction Portal, Life Insurance, ERP system etc. - I do have require mobile devices to test mobile view or applications like android and iOS applications. - I have hands on experience with Git, postman, MSSQL Server. Kindly review my profile and let me know you view over the same. Thanks, Haresh

@mohitk0111

Clarification Required for Project Approval :- The following information is required to accurately define the project scope, effort, timeline, and compliance requirements. These details were not provided and should be confirmed before project approval: 1. Type of Software System Please specify the software system that requires validation (e.g., Laboratory Information Management System (LIMS), Manufacturing Execution System (MES), ERP, Clinical, Medical Device Software, Custom Application, etc.). Current Validation Lifecycle Stage Please indicate the current phase of the software validation lifecycle, such as: Planning 2. Requirements Definition Risk Assessment Validation Protocol Development Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Execution Report Generation Change Control / Periodic Review Applicable Regulatory Standards and Guidelines 3. Please identify the regulatory requirements and standards that the software must comply with, for example: GAMP 5 FDA 21 CFR Part 11 EU GMP Annex 11 ISO 13485 IEC 62304 ALCOA+ Data Integrity Principles Other applicable regional or customer-specific requirements Note: In the absence of the above information, the proposed effort, cost, timeline, and deliverables are preliminary and may be revised once the required project details are confirmed.