Computer System Validation (CSV) is a process used to ensure that computer-based systems used in regulated industries, such as pharmaceuticals, healthcare, and finance, operate in a manner that meets regulatory requirements and produces reliable and accurate results. The purpose of CSV is to confirm that a computer system performs its intended functions consistently and reliably, while also meeting regulatory compliance standards, such as those set by the Food and Drug Administration (FDA) in the United States.
The Food and Drug Administration's (FDA's) the Code of Federal Regulations Electronic Records; Electronic Signatures (21 CFR Part 11)
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Food and Drug Administration is a federal agency of the Department of Health and Human Services. We are providing Computer System Validation services are a prevailing challenge for the Pharma industries
Computer System Validation (CSV) is required by regulatory agencies to verify that a computerized system consistently works as intended.
Validating HPLC and GC systems is crucial to ensure their reliability, accuracy, and compliance with regulatory requirements.
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1. Planning: This involves defining the scope of validation, determining the resources needed, and developing a validation plan that outlines the validation approach, responsibilities, and timelines.
2. User Requirements Specification (URS): This document outlines the functional and non-functional requirements of the system from the user's perspective.
3. Functional Requirements Specification (FRS): The FRS describes in detail how the system will fulfill the requirements outlined in the URS.
4. Design Specification (DS): The DS documents the technical design of the system, including hardware, software, interfaces, and data structures.
5. Installation Qualification (IQ): IQ verifies that the system is installed correctly according to manufacturer specifications and regulatory requirements.
6. Operational Qualification (OQ): OQ verifies that the system functions as intended within its operational environment.
7. Performance Qualification (PQ): PQ confirms that the system consistently performs according to predefined specifications and user requirements in its intended environment.
8. Validation Summary Report (VSR): The VSR summarizes the validation activities, findings, and conclusions.
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