Computer System Validation (CSV) ensures that software systems fulfill their intended purposes in regulated life science industries. CSV involves controls and procedures throughout the entire Software Development Life Cycle to document evidence of quality. It is more than just testing and aims to prevent software problems and comply with stringent FDA regulations. CSV occurs through various verification and validation activities at each stage of development to confirm requirements are met.
Computer system validation review article by-mahesh b wazadeMahesh B. Wazade
Computer system validation (CSV) is the process of documenting that a computer system meets defined system requirements. It ensures computerized systems perform as intended in a consistent manner. CSV is important for regulated industries like pharmaceuticals where computer systems are used for quality control and record-keeping. Regulations like 21 CFR Part 11 require electronic records to be validated. CSV enhances reliability and reduces errors and risks to integrity.
This document provides an introduction and overview of computer validation training. It discusses why computer validation is important for business, safety, and regulatory reasons. It explains that computer validation has been a regulatory requirement for over 20 years, but scrutiny has increased significantly in recent years. The document outlines the basics of what constitutes a computer system and the validation process, who plays key roles in validation, and why defects in computer systems can have more severe consequences than other equipment problems.
General Principals Of Software Validationstaciemarotta
Here are the key definitions and terminology related to software validation:
3.1.1 Requirements and Specifications
Requirements define what the software should do. Specifications define how the software will meet the requirements. Requirements and specifications should be documented, agreed upon, controlled and traceable.
3.1.2 Verification and Validation
Verification ensures the software meets specifications. Validation ensures the software meets the intended use and user needs. Both are required to confirm the software functions as intended and is safe for clinical use.
3.1.3 IQ/OQ/PQ
IQ (Installation Qualification) confirms the software system is installed correctly. OQ (Operational Qualification) confirms the software system operates
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
Process and Regulated Processes Software Validation ElementsArta Doci
Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
Computer system validation review article by-mahesh b wazadeMahesh B. Wazade
Computer system validation (CSV) is the process of documenting that a computer system meets defined system requirements. It ensures computerized systems perform as intended in a consistent manner. CSV is important for regulated industries like pharmaceuticals where computer systems are used for quality control and record-keeping. Regulations like 21 CFR Part 11 require electronic records to be validated. CSV enhances reliability and reduces errors and risks to integrity.
This document provides an introduction and overview of computer validation training. It discusses why computer validation is important for business, safety, and regulatory reasons. It explains that computer validation has been a regulatory requirement for over 20 years, but scrutiny has increased significantly in recent years. The document outlines the basics of what constitutes a computer system and the validation process, who plays key roles in validation, and why defects in computer systems can have more severe consequences than other equipment problems.
General Principals Of Software Validationstaciemarotta
Here are the key definitions and terminology related to software validation:
3.1.1 Requirements and Specifications
Requirements define what the software should do. Specifications define how the software will meet the requirements. Requirements and specifications should be documented, agreed upon, controlled and traceable.
3.1.2 Verification and Validation
Verification ensures the software meets specifications. Validation ensures the software meets the intended use and user needs. Both are required to confirm the software functions as intended and is safe for clinical use.
3.1.3 IQ/OQ/PQ
IQ (Installation Qualification) confirms the software system is installed correctly. OQ (Operational Qualification) confirms the software system operates
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
Process and Regulated Processes Software Validation ElementsArta Doci
Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
This document provides an overview of a presentation on computer system validation practices. It discusses regulatory requirements, best practices guidance, quality risk management, and life cycles for computer systems and validation. The presentation covers topics such as ICH guidelines, GAMP5, risk-based approaches to validation, and integration of validation life cycles with system development and project management life cycles. It also references sources such as FDA guidance documents and international standards. The document consists of an agenda and slides outlining key concepts and approaches to computer system validation.
This document provides definitions and explanations of key concepts related to computerized system validation (CSV) and regulatory compliance. It defines terms like CSV, GxP, data integrity, validation, and regulatory bodies like the US FDA, EMA, and CDSCO. It also explains concepts such as qualification, deviation handling, change control, and documentation for validated systems like user requirements, validation plans, and reports. Overall, the document serves as an introduction to the important terminology and principles of CSV and compliance.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Computer System Validation – Reduce Costs and Avoid 483sReferral
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
For More Info:
https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=slideshare.net
Quality Control for Medical Device Software - It Arena Lviv PresentationRoman Lavriv
This document discusses quality control for medical device software. It covers:
1) Regulations that govern medical device software from standards organizations like the FDA and IEC.
2) The V-model process for requirements, design, verification, and validation.
3) The importance of verification and validation, including static and dynamic testing, to ensure the software meets requirements and functions as intended.
The document discusses the challenges of traditional paper-based computer system validation (CSV) processes, including inefficiencies from manual tasks, lack of integration and traceability, and compliance risks. It introduces ValGenesis as a validation lifecycle management system (VLMS) that automates the entire CSV process electronically, including requirement management, risk assessment, protocol creation, electronic execution, traceability, and reporting. ValGenesis improves efficiency by eliminating manual tasks, expediting the validation process by 50%, and enhancing consistency and compliance through integrated electronic management of the entire validation lifecycle.
This document summarizes key concepts from Chapter 15 on resilience engineering. It discusses resilience as the ability of systems to maintain critical services during disruptions like failures or cyberattacks. Resilience involves recognizing issues, resisting failures when possible, and recovering quickly through activities like redundancy. The document also covers sociotechnical resilience, where human and organizational factors are considered, and characteristics of resilient organizations like responsiveness, monitoring, anticipation, and learning.
Integration OF Human Factors Engineering with Design ControlsEMMAIntl
Our Sr. Quality Engineer Matt Ward explains how to build a strong Design History File for your product by incorporating human factors engineering into the design controls and risk management plan for your product. Learn how risks can be mitigated in the early stages of product development by integrating HFE into the design of your product.
This document discusses computerized system validation (CSV) and quality assurance principles for ensuring reliable computerized systems. It defines CSV as establishing evidence that a process will consistently produce products meeting specifications. The validation process should be performed during software development and includes master planning, installation qualification, operational qualification, and performance qualification. Quality assurance focuses on processes, while quality control focuses on products. The document also outlines responsibilities for validation, and the software development life cycle of planning, designing, building, testing, deploying, using, and retiring a system.
This document summarizes an article from the International Journal of Industrial Engineering and Development titled "Development and Application of SFMEA Model to Software Testing Environment". It discusses using Failure Mode and Effects Analysis (FMEA) to improve software quality assurance. Specifically, it proposes developing a Software FMEA (SFMEA) model to identify potential failures, their causes and effects, for three banking software projects. The document reviews literature on SFMEA and discusses implementing the model to analyze failures and recommend corrective actions. It describes calculating a Risk Priority Number to prioritize failures and validate that the SFMEA model reduces this number and improves software quality.
Static analysis, reliability testing, and security testing are techniques for validating critical systems. Additional validation processes are required for critical systems due to the high costs and consequences of failure. Validation costs for critical systems are significantly higher than for non-critical systems, typically taking up more than 50% of total development costs. The outcome of the validation process is evidence that demonstrates the system's level of dependability.
With new technologies come many innovative medical devices and tools to help treat patients and to improve their quality of life thru diagnosis, monitoring and therapy. New fields of study within Engineering are emerging throughout the academic community to better understand and improve these devices and tools. As a Systems Engineer what are we doing in this application that’s different from others? What are the challenges? What do we need to improve on? And Why?
This presentation provides an overview of the different types of Medical Devices and addresses the associated implications that affect the system under design. An example of a specific Medical Device will be presented along with a description of how the system integrates with Biological component. Systems Engineering Process comparison between Medical Device industry and Defense industry where Systems Engineering was conceived has been integrated throughout this presentation. You will learn more about some of the challenges that Medical Devices industry is facing and potential Systems Engineering solutions with specific approach and methodology.
Systems Engineering and Requirements Management in Medical Device Product Dev...UBMCanon
Systems engineering is an interdisciplinary approach that focuses on defining customer needs, documenting requirements, and enabling the realization of successful systems. It considers both business and technical needs across the entire life cycle from concept to disposal. Requirements management is the foundation of systems engineering. Organizations can improve processes and reduce risks through structured approaches like the Systems Engineering V-Model and maturity models like CMMI that provide standard processes and best practices. Verification and validation are used to ensure a system meets its requirements through methods like testing, analysis and demonstration.
CAST’s U.S. Federal group helps government agencies maximize IT investments and optimize performance through the use of proven technologies and best practices.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Software testing and introduction to qualityDhanashriAmbre
The document provides an overview of software testing and quality assurance. It defines software testing as a process to investigate quality and find defects between expected and actual results. Testing is necessary to ensure software is defect-free per customer specifications and increases reliability. The document then discusses types of errors like ambiguous specifications, misunderstood specifications, and logic/coding errors. It outlines the software development life cycle including phases like planning, analysis, design, coding, testing, implementation, and maintenance. Each phase is described in 1-2 sentences.
The document provides an overview of software engineering, discussing what it is, why it is important, and key concepts like the software development lifecycle, processes, and models. It introduces software engineering as a way to build software in a controlled, predictable manner by giving control over functionality, quality, and resources. It also summarizes several software development process models like waterfall, evolutionary development, and spiral.
This document provides an overview of computer validation and compliance with regulatory guidance. It discusses the need for computer validation and outlines key principles from guidance documents such as software validation, use of off-the-shelf software in medical devices, and validation of electronic records and signatures. Validation approaches for different systems and software are covered, including spreadsheets. The document provides references to FDA and international regulatory guidance on these topics.
This document discusses Pakipoint, a company that provides order fulfillment and delivery services. It offers competitive shipping rates through contracts with multiple couriers. Pakipoint's services include shipment administration tools, picking/packing/warehousing, fulfillment software rental, delivery solutions for retail customers, and integration with e-commerce platforms. The company aims to help e-shops outsource order fulfillment to optimize their primary competencies of purchasing, management, and marketing.
The document provides a summary of the key pages and functionality of an insurance quote management application called Coffee House. It describes pages for new users to sign up, returning users to log in, view dashboard pages with quotes, apply filters to quotes, and see notifications. The summary focuses on the main user flows and interactions within the application.
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
This document provides an overview of a presentation on computer system validation practices. It discusses regulatory requirements, best practices guidance, quality risk management, and life cycles for computer systems and validation. The presentation covers topics such as ICH guidelines, GAMP5, risk-based approaches to validation, and integration of validation life cycles with system development and project management life cycles. It also references sources such as FDA guidance documents and international standards. The document consists of an agenda and slides outlining key concepts and approaches to computer system validation.
This document provides definitions and explanations of key concepts related to computerized system validation (CSV) and regulatory compliance. It defines terms like CSV, GxP, data integrity, validation, and regulatory bodies like the US FDA, EMA, and CDSCO. It also explains concepts such as qualification, deviation handling, change control, and documentation for validated systems like user requirements, validation plans, and reports. Overall, the document serves as an introduction to the important terminology and principles of CSV and compliance.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Computer System Validation – Reduce Costs and Avoid 483sReferral
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
For More Info:
https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=slideshare.net
Quality Control for Medical Device Software - It Arena Lviv PresentationRoman Lavriv
This document discusses quality control for medical device software. It covers:
1) Regulations that govern medical device software from standards organizations like the FDA and IEC.
2) The V-model process for requirements, design, verification, and validation.
3) The importance of verification and validation, including static and dynamic testing, to ensure the software meets requirements and functions as intended.
The document discusses the challenges of traditional paper-based computer system validation (CSV) processes, including inefficiencies from manual tasks, lack of integration and traceability, and compliance risks. It introduces ValGenesis as a validation lifecycle management system (VLMS) that automates the entire CSV process electronically, including requirement management, risk assessment, protocol creation, electronic execution, traceability, and reporting. ValGenesis improves efficiency by eliminating manual tasks, expediting the validation process by 50%, and enhancing consistency and compliance through integrated electronic management of the entire validation lifecycle.
This document summarizes key concepts from Chapter 15 on resilience engineering. It discusses resilience as the ability of systems to maintain critical services during disruptions like failures or cyberattacks. Resilience involves recognizing issues, resisting failures when possible, and recovering quickly through activities like redundancy. The document also covers sociotechnical resilience, where human and organizational factors are considered, and characteristics of resilient organizations like responsiveness, monitoring, anticipation, and learning.
Integration OF Human Factors Engineering with Design ControlsEMMAIntl
Our Sr. Quality Engineer Matt Ward explains how to build a strong Design History File for your product by incorporating human factors engineering into the design controls and risk management plan for your product. Learn how risks can be mitigated in the early stages of product development by integrating HFE into the design of your product.
This document discusses computerized system validation (CSV) and quality assurance principles for ensuring reliable computerized systems. It defines CSV as establishing evidence that a process will consistently produce products meeting specifications. The validation process should be performed during software development and includes master planning, installation qualification, operational qualification, and performance qualification. Quality assurance focuses on processes, while quality control focuses on products. The document also outlines responsibilities for validation, and the software development life cycle of planning, designing, building, testing, deploying, using, and retiring a system.
This document summarizes an article from the International Journal of Industrial Engineering and Development titled "Development and Application of SFMEA Model to Software Testing Environment". It discusses using Failure Mode and Effects Analysis (FMEA) to improve software quality assurance. Specifically, it proposes developing a Software FMEA (SFMEA) model to identify potential failures, their causes and effects, for three banking software projects. The document reviews literature on SFMEA and discusses implementing the model to analyze failures and recommend corrective actions. It describes calculating a Risk Priority Number to prioritize failures and validate that the SFMEA model reduces this number and improves software quality.
Static analysis, reliability testing, and security testing are techniques for validating critical systems. Additional validation processes are required for critical systems due to the high costs and consequences of failure. Validation costs for critical systems are significantly higher than for non-critical systems, typically taking up more than 50% of total development costs. The outcome of the validation process is evidence that demonstrates the system's level of dependability.
With new technologies come many innovative medical devices and tools to help treat patients and to improve their quality of life thru diagnosis, monitoring and therapy. New fields of study within Engineering are emerging throughout the academic community to better understand and improve these devices and tools. As a Systems Engineer what are we doing in this application that’s different from others? What are the challenges? What do we need to improve on? And Why?
This presentation provides an overview of the different types of Medical Devices and addresses the associated implications that affect the system under design. An example of a specific Medical Device will be presented along with a description of how the system integrates with Biological component. Systems Engineering Process comparison between Medical Device industry and Defense industry where Systems Engineering was conceived has been integrated throughout this presentation. You will learn more about some of the challenges that Medical Devices industry is facing and potential Systems Engineering solutions with specific approach and methodology.
Systems Engineering and Requirements Management in Medical Device Product Dev...UBMCanon
Systems engineering is an interdisciplinary approach that focuses on defining customer needs, documenting requirements, and enabling the realization of successful systems. It considers both business and technical needs across the entire life cycle from concept to disposal. Requirements management is the foundation of systems engineering. Organizations can improve processes and reduce risks through structured approaches like the Systems Engineering V-Model and maturity models like CMMI that provide standard processes and best practices. Verification and validation are used to ensure a system meets its requirements through methods like testing, analysis and demonstration.
CAST’s U.S. Federal group helps government agencies maximize IT investments and optimize performance through the use of proven technologies and best practices.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Software testing and introduction to qualityDhanashriAmbre
The document provides an overview of software testing and quality assurance. It defines software testing as a process to investigate quality and find defects between expected and actual results. Testing is necessary to ensure software is defect-free per customer specifications and increases reliability. The document then discusses types of errors like ambiguous specifications, misunderstood specifications, and logic/coding errors. It outlines the software development life cycle including phases like planning, analysis, design, coding, testing, implementation, and maintenance. Each phase is described in 1-2 sentences.
The document provides an overview of software engineering, discussing what it is, why it is important, and key concepts like the software development lifecycle, processes, and models. It introduces software engineering as a way to build software in a controlled, predictable manner by giving control over functionality, quality, and resources. It also summarizes several software development process models like waterfall, evolutionary development, and spiral.
This document provides an overview of computer validation and compliance with regulatory guidance. It discusses the need for computer validation and outlines key principles from guidance documents such as software validation, use of off-the-shelf software in medical devices, and validation of electronic records and signatures. Validation approaches for different systems and software are covered, including spreadsheets. The document provides references to FDA and international regulatory guidance on these topics.
This document discusses Pakipoint, a company that provides order fulfillment and delivery services. It offers competitive shipping rates through contracts with multiple couriers. Pakipoint's services include shipment administration tools, picking/packing/warehousing, fulfillment software rental, delivery solutions for retail customers, and integration with e-commerce platforms. The company aims to help e-shops outsource order fulfillment to optimize their primary competencies of purchasing, management, and marketing.
The document provides a summary of the key pages and functionality of an insurance quote management application called Coffee House. It describes pages for new users to sign up, returning users to log in, view dashboard pages with quotes, apply filters to quotes, and see notifications. The summary focuses on the main user flows and interactions within the application.
Sosiaalinen media aloita palveluiden käyttöVesa Rinne
Pikaohje erilaisten sosiaalisen median palveluiden käytön aloittamiseksi. Tässä materiaalissa ei paneuduta tarkemmin itse palveluihin vaan ainoastaan siihen kuinka niihin rekisteröidytään.
Ronald Reagan was a conservative American politician who served as the 40th President of the United States from 1981 to 1989. Some key details about his life and presidency include: He was born in 1911 in Illinois and got his start in Hollywood before pursuing a career in politics. As President, Reagan advocated for lower taxes, less government regulation of the economy, and increased defense spending. His policies aimed to stimulate economic growth and roll back communism. However, his presidency was also marked by controversies like the Iran-Contra affair and growing inequality.
Donando sangre regularmente se puede salvar hasta 4 vidas cada 3 meses, o hasta 12 vidas por año, ya que una sola donación de sangre se divide en tres componentes que pueden beneficiar a tres pacientes diferentes. Cada donación de sangre es crucial porque una de cada diez personas que ingresan al hospital necesitan transfusiones de sangre, y solo el 5% de las personas elegibles donan sangre anualmente a pesar de que la necesidad es constante.
We want to tell you who we are, what we do and what we've done for our customers this far. Understanding our customers’ needs and genuine service-mindedness are the very essence of our operations as we focus to various ECM and content management solutions. We are IBM Premier Business Partner.
Este documento trata sobre el tema de la muerte desde diferentes perspectivas. Explora conceptos como la muerte biológica, la muerte cerebral, las consecuencias psicológicas de la muerte humana y los debates éticos relacionados con la muerte. También incluye definiciones de diferentes tipos de muerte y varias citas sobre la muerte de distintos autores.
A book report of Bapsi Sidhwa's novel, Ice Candy Man, for a school assignment. The book is based on the partition of 1947. It was also made into a movie, Earth: 1947.
The document discusses the concept of organizational learning and competitive advantage. It states that in the long run, the only sustainable competitive edge is an organization's ability to learn faster than its competitors. It then outlines five disciplines of organizational learning: personal mastery, mental models, building a shared vision, team learning, and systems thinking. It describes each discipline and some common "learning disabilities" such as seeing oneself as one's position and the illusion of taking charge. The overall message is that organizations must overcome these learning disabilities and cultivate the five disciplines to learn effectively and gain a competitive advantage.
El documento describe la morfología y desarrollo de los insectos de la clase Insecta. Los insectos se caracterizan por poseer tres pares de patas y experimentan una metamorfosis completa u holometabolia que incluye los estadios de huevo, ninfa, pupa y adulto. Se mencionan varios órdenes importantes como los himenópteros, dípteros, coleópteros y hemípteros, así como familias que incluyen chinches, mosquitos y moscas que son vectores de enfermed
El páncreas es una glándula digestiva accesoria situada en la cavidad abdominal detrás del estómago. Cumple funciones exocrinas secretando enzimas digestivas al duodeno, y funciones endocrinas a través de los islotes de Langerhans que secretan insulina, glucagón y somatostatina para regular los niveles de glucosa en la sangre. El páncreas recibe irrigación sanguínea de las arterias pancreaticoduodenales superior e inferior, y drena su sangre a las venas mesentérica superior y esplén
Este documento resume los conceptos básicos de fisiología, incluyendo que estudia la función e integración de los tejidos, órganos y sistemas del cuerpo. Explica que la homeostasis es el proceso por el cual el cuerpo mantiene un estado de equilibrio interno a través de mecanismos de retroalimentación negativa y positiva. Los órganos y sistemas como el nervioso y endocrino trabajan juntos para regular las funciones corporales y mantener la homeostasis.
Clase brindada por la ex residente, Dra. Jeimmys Orozco Lora, Anestesiologa de planta del servicio de anestesiología del HPN. En ella se detallan los principios básicos de la fisiología del estado acido base, enunciándose las principales alteraciones a las que éste está sujeto y su relación con la anestesiología.
The document provides an overview of computerized system validation. It defines computerized system validation as the process of testing, validating, and qualifying a regulated computerized system to ensure it operates as designed in a consistent and reproducible manner. The document discusses the difference between computer systems and computerized systems, why validation is needed in the pharmaceutical industry, types of validation, applicable regulatory requirements like 21 CFR Part 11, and the GAMP 5 categories for classifying computerized systems. It provides key points about computerized system validation and the V-model approach for validation stages and deliverables.
Validation requirements apply to all medical device software regardless of its class or whether it is a software component or itself a medical device. Software validation should confirm that software specifications meet user needs and intended uses, and requirements can be consistently fulfilled. A software validation plan and procedure are required to outline and govern validation activities to develop confidence the device meets all user requirements. Since small changes can impact the system, validation status must be re-established after any change through appropriate regression testing to ensure no adverse effects. While off-the-shelf software validation can be difficult, the device manufacturer is responsible for compliance with FDA validation requirements through vendor verification and auditing design methodologies.
Project Pluto Will Adopt The Incremental Build Model EssayDiane Allen
The validation package should include a validation protocol, validation reports summarizing the results of executing the protocol, and a conclusion on whether the process or system passed validation. It provides documented evidence that the process, equipment, or system performs as intended based on predetermined acceptance criteria. The package gives quality assurance confidence in consistent and repeatable operations.
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation. The objective of regulated computer systems includes systems
used to manage data or support descion making subject to review by regulated authorities whether they are being
submitted because its impact on quality or on business. Investments in computer systems supporting the quality controls
to ensure that the process is followed correctly, reducing human error and the need to conduct manual checks,
Standardization of practices to build consistent ways of working, Speed-up of process cycle times by reducing wait times
and by improved scheduling...etc.Computer systems shouldn't be enforced only for restrictive compliance; operational
advantages must always be exploredas well. “U.S. Code of Federal Regulation 21 CFR Part 600, 606, and 610” and “EU
Directive 2003/94/EEC” are the prominent regulations reqested CSV, while “Volume 4 Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use - Annex 11: Computerised Systems” considered the main guidlines for
CSV in biopharmaceutical industries in European Union. This paper aims to provide simplifed guidance on the basic
requireents for computer system validation (CSV) based on the latest regulatory developments and industry trends. In
conclusion, CSV has the great impact on the processes improvement. Also the critical parameters of computer systems
validation for biopharmaceutical indsutries are highlighted.
#AHMED_HASHAM
https://medwinpublishers.com/OAJPR/computerized-systems-validation-csv-in-biopharmaceutical-industries.pdf
computer system is a latest validation system in pharmaceutical industries.
To compliance with the good laboratory practice and good manufacturing practice.
it`s part of 211CFR part 11.
Software testing for project report .pdfKamal Acharya
Methods of Software Testing There are two basic methods of performing software testing: 1. Manual testing 2. Automated testing Manual Software Testing As the name would imply, manual software testing is the process of an individual or individuals manually testing software. This can take the form of navigating user interfaces, submitting information, or even trying to hack the software or underlying database. As one might presume, manual software testing is labor-intensive and slow.
Defining an IT Auditor,
IT Auditor Certifications & ISACA,
IT Audit Phases,
Preparing to be Audited,
How IT auditor audits an Applications,
Auditing technology for Information System.
This document summarizes a presentation on computer-assisted audit tools and techniques (CAATTs). It discusses using CAATTs to test input controls, processing controls, and output controls. Specific techniques covered include test data methods, base case system evaluation, tracing, integrated test facilities, and parallel simulation. CAATTs allow auditors to more efficiently and effectively test controls and analyze large datasets compared to traditional audit sampling methods. The use of specialized software tools is helping to improve the audit process.
The Use of Spreadsheets: As it relates to Section 404 of the Sarbanes-Oxley Act.gueste080564
The use of spreadsheets in financial reporting and operational processes, is a key tool for some corporations, and is an integral part of the information and decision-making framework.
The Use of Spreadsheets: As it relates to Section 404 of the Sarbanes-Oxley Act.renetta
The use of spreadsheets in financial reporting and operational processes, is a key tool for some corporations, and is an integral part of the information and decision-making framework.
Technology Controls in Business - End User Computingguestc1bca2
The Use of Spreadsheets: As it relates to Section 404 of the Sarbanes-Oxley Act.
The use of spreadsheets in financial reporting and operational processes, is a key tool for some corporations, and is an integral part of the information and decision-making framework.
The document discusses the FDA review process for medical device software. It provides an overview of regulatory requirements for software validation and guidelines for the content of pre-market submissions to the FDA. The summary should include documentation of hazards analysis, requirements specifications, design documentation, verification and validation testing results, and resolution of any unresolved anomalies. The level of documentation depends on the level of concern for the software.
This document provides an overview of software development lifecycles and testing. It discusses the typical phases of the SDLC, including planning, analysis, design, implementation, and maintenance. It describes two common SDLC methodologies: the waterfall model and agile/scrum model. It also defines different types of testing like static vs dynamic, verification vs validation, functional testing, regression testing, and smoke testing. Finally, it provides details on unit, integration, system, and user acceptance testing.
This document discusses defect prediction models in software development. It begins by covering the importance of effort estimation in software maintenance planning and management. The document then discusses how data from software defect reports, including details on defects, components, testers and fixes, can be used to build reliability models to predict remaining defects. Machine learning and data mining techniques are proposed to analyze relationships between software quality across releases and to construct predictive models for forecasting time to fix defects. The document provides an overview of typical software development processes and then discusses a two-step approach to defect prediction and analysis using appropriate statistics and data mining techniques.
The Role of Verification and Validation in System Development Life CycleIOSR Journals
Verification and validation (V&V) are important parts of the system development life cycle that help ensure software quality. Verification determines if the product meets requirements, while validation checks if it fulfills its intended purpose. V&V techniques include reviews, testing, and audits at all phases of development. Proper V&V helps deliver high quality software that satisfies client needs on time.
Fundamentals of Testing - Andika Dwi Ary CandraAnd11ka
1. The document introduces software testing fundamentals, defining key terms like defect, error, failure, and quality.
2. It explains that testing is necessary to find software defects that can cause problems, and that the cost of fixing defects rises significantly if found later in the development process.
3. The roles of testing are to identify defects during development and maintenance to reduce failures and improve quality in operations. Rigorous testing helps deliver software that meets specifications and customer needs.
This document discusses various topics related to software testing including:
- The purpose of software testing is to ensure software works as expected and to detect errors. Testing involves executing a system under controlled conditions and evaluating results.
- There are two primary types of testing: black box testing which ignores internal mechanisms and focuses on inputs/outputs, and white box testing which considers internal mechanisms.
- Key stages of testing include unit testing, integration testing, functional/system testing, acceptance testing, regression testing, and beta testing. Regression testing verifies modifications have not caused unintended effects.
1. Page 1 of 8
Computer System Validation - It’s More Than Just Testing
Introduction
Computer System Validation is the technical discipline that Life Science companies use to ensure
that each Information Technology application fulfills its intended purpose. Stringent quality
requirements in FDA regulated industries impose the need for specific controls and procedures
throughout the Software Development Life Cycle (SDLC). Evidence that these controls and
procedures have been followed and that they have resulted in quality software (software that
satisfies its requirements) must be documented correctly and completely. These documents must
be capable of standing up to close scrutiny by trained inspectors since the financial penalty for
failing an audit can be extremely high. More importantly, a problem in a Life Science software
application that affects the production environment could result in serious adverse consequences,
including possible loss of life.
The activities involved in applying the appropriate controls/procedures throughout the SDLC and
for creating the necessary trail of documented evidence are all part of the technical discipline of
Computer System Validation. As we will discuss in this article, software testing is a key component
in this discipline. However, Computer System Validation, involves more than what many IT people
consider to be software testing.
What is Computer System Validation and Why is it Important?
A key source document providing FDA guidance on the general topic of Validation is “General
Principles of Validation, Food and Drug Administration” from the Center for Drug Evaluation and
Research. [1]. The definition of Validation in this document is:
Establishing documented evidence which provides a high degree of assurance that a
specific process will consistently produce a product meeting its predetermined
specification and quality attributes.
Validation, as described in this document, is aimed at manufacturers of pharmaceuticals and
medical devices who must demonstrate that their processes produce consistent product quality. It
applies to all processes that fall under FDA regulation, including, but not limited to, computer
systems. For example, Validation applies to pharmaceutical manufacturing processes which
include checking, cleaning, and documenting that all equipment used in manufacturing operates
according to predetermined specifications. Computer System Validation (or Computerized System
Validation as it sometimes called in the literature) is the result of applying the above definition to
a Computer System:
Establishing documented evidence which provides a high degree of assurance that a
Computer System will consistently produce results that meet its predetermined
specification and quality attributes.
Note that a “Computer System” in the Life Sciences sector is more than computer hardware and
software. It also includes the equipment and instruments linked to the system (if any) as well as
the trained staff that operate the system and/or equipment using Standard Operating Procedures
(SOPs) and manuals.
2. Page 2 of 8
As applied to computer systems, the FDA definition of Validation is an umbrella term that is
broader than the way the term validation is commonly used in the IT industry. In the IT industry,
validation usually refers to performing tests of software against its requirements [2]. A related term
in the IT world is verification, which usually refers to Inspections, Walkthroughs, and other reviews
and activities aimed at ensuring that the results of successive steps in the software development
cycle correctly embrace the intentions of the previous step [3, 4]. As we will see below, FDA
Validation of computer systems includes all of these activities with a key focus on producing
documented evidence that will be readily available for inspection by the FDA. So testing in the
sense of executing the software is only one of multiple techniques used in Computer System
Validation.
There are two key reasons why Computer System Validation is extremely important in the Life
Science sector:
1. Systematic Computer System Validation helps prevent software problems from reaching
production environments. As previously mentioned, a problem in a Life Science software
application that affects the production environment can result in serious adverse
consequences. Besides the obvious humanistic reasons that the Life Science sector strives
to prevent such harm to people, the business consequences of a software failure affecting
people adversely can include lawsuits, financial penalties and manufacturing facilities
getting shut down. The ultimate result could be officers getting indicted, the company
suffering economic instabilities, staff downsizing, and possibly eventual bankruptcy.
2. FDA regulations mandate the need to perform Computer System Validation and these
regulations have the impact of law. Failing an FDA audit can result in FDA inspectional
observations (“483s”) and warning letters. Failure to take corrective action in a timely
manner can result in shutting down manufacturing facilities, consent decrees, and stiff
financial penalties. Again, the ultimate result could be loss of jobs, indictment of
responsible parties (usually the officers of a company), and companies suffering economic
instabilities resulting in downsizing and possibly eventual bankruptcy.
A key point to be gleaned from 1 and 2 above is that not only do FDA regulated companies need
to do Computer System Validation, but they need to do it right. Cutting corners on doing a
Validation might save a little money in the short term but these savings will look minute and
inconsequential when compared to the potential costs and impacts of not doing the Validation
correctly.
Relationship of Computer System Validation to the Software Development Life Cycle1
Computer System Validation is carried out through activities that occur throughout the entire
Software Development Life Cycle (SDLC). The “V Diagram” (Figure 1) is widely used in the IT
literature to emphasize the importance of testing and testing related activities at every step in the
SDLC. The V-diagram is really a recasting of the oft-criticized “Waterfall” model of the SDLC.
In fact the phases in the Waterfall Model are essentially the life cycle phases that appear on the left-
hand side of the V-diagram. The V-diagram emphasizes the need for various forms of testing to be
part of every step along the way. This avoids a “big-bang” testing effort at the very end of the
process, which has been one of the main criticisms associated with the Waterfall model (or the way
some have people have interpreted the Waterfall model). The activities represented in the V-
Diagram (labeled V &V in Figure 1) include Static Testing as well as Dynamic Testing activities.
Static Testing (sometimes called Static Analysis) refers to inspections, walkthroughs, and other
review/analysis activities that can be performed without actually executing the software. In
1
This section of the article draws freely from material that will appear in a new book by the author [5].
3. Page 3 of 8
Dynamic Testing, the software is actually executed and compared against expected results. While
many IT people use the term “testing” to mean dynamic testing, both dynamic and static testing
activities are used in Computer System Validation to help ensure that the results of successive steps
in the SDLC correctly fulfill the intentions of the previous step [4].
Different types of activities represented in the V-Diagram are sometimes distinguished by the terms
Verification and Validation, words whose connotations in the IT world were discussed in the
previous section. In some visualizations of the V-Diagram [see reference 3, for example], the term
“Verification” is associated with the activities shown on the left hand side of the V and
“Validation” associated with activities on the right hand side. At this point in time there are reasons
why it may be preferable to avoid drawing this distinction. First, the IEEE definitions of these two
terms have become so close [6] that it is hardly worth trying to articulate (or even remember) the
difference. It is more productive to just call them V&V activities (as is done throughout the text of
[6]). Secondly, in companies regulated by the FDA and other regulatory bodies throughout the
world, the term Validation is often used interchangeably with Computer System Validation when
discussing the activities required to demonstrate that a software system meets its intended purpose.
In a sense, Computer System Validation has actually extended the V-Model and put a more user
driven spin on it. As shown pictorially in Figure 2, Computer System Validation has several
important features:
• Computer System Validation is driven by the “User”. That is the organization choosing to
apply the software to satisfy a business need is accountable for the Validation of that
software. While the software supplier, the IT organization, the QA organization, and
consultants can play important roles in a Computer System Validation, it is the User
organization that is responsible for seeing that documented evidence supporting the
Validation activities is accumulated.
• The User must write “User Requirements Specifications” (URS) to serve as the basis for a
Computer System Validation. The URS provides the requirements the Computer System
must fulfill for meeting business needs. A Computer System Validation cannot be done
unless such a URS exists.
• The Supplier of the Computer System should provide Functional Specifications and Design
Specifications, which satisfy the URS. Where such Specifications are not available for an
existing system, they are sometimes developed by “reverse engineering” the functionality
of the system.
• Users are involved in every step of the process (deeply involved for custom development,
less for package based systems)
• A three level-structure is imposed on User Testing:
- The Installation Qualification or IQ focuses on testing that the installation has
been done correctly
- The Operational Qualification or OQ focuses on testing of functionality in the
system installed at the User site
- The Performance Qualification or PQ focuses on testing that users, administrators,
and IT support people trained in the SOPs can accomplish business objectives in
the production environment even under worst case conditions.
How does a Life Science Company Determine What Needs to be Done in a Specific
Computer System Validation?
The way an individual company approaches Computer System Validation is based on the
company’s interpretation of FDA Regulations and FDA Guidance documents as well as their efforts
to adopt industry Best Practices. Best Practices include Life Science industry group guidelines
(such as [7]) and IT standards (such as [6]). Some of the FDA Regulations provide rules on the
4. Page 4 of 8
Quality System under which Life Sciences companies must operate known as the “regulated GxP
environments”. GxP is an umbrella term that covers:
• GMP: Good Manufacturing Practice (sometimes called Current Good Manufacturing
Practice or cGMP)
• GLP: Good Laboratory Practice
• GCP: Good Clinical Practice
These codes/quality systems are sometimes referred to collectively as the Predicate Rules.
Depending on the software application, different Predicate Rules may apply. For example, there
are specific regulations that cover medical device software (21 CFR 820.30 (g)). Guidance on
validation of medical device software is provided in an FDA paper called General Principles of
Software Validation: Final Guidance for Industry and FDA Staff [8].
The FDA has been striving to make its Quality System regulations consistent with the requirements
for quality systems contained in applicable international standards. This includes the International
Organization for Standards (ISO) ISO 9000 : 2000 “Quality Management Systems” and the
ISO/CD 13485 ‘‘Quality Systems—Medical Devices—Supplementary Requirements to ISO
9001’’. So companies who follow these standards will find that Computer System Validation is
well harmonized with their individual Quality Systems.
The GAMP Forum (Good Automated Manufacturing Processes Forum) focuses on the application
of GxP to the IT environment. The GAMP Guide for Validation of Automated Systems [7] is said
to be the most widely used, internationally accepted, guideline for validation of computer systems.
The ISPE (International Society for Pharmaceutical Engineering) and the GAMP Forum jointly
produce the GAMP Guide.
In addition to the FDA Regulations, FDA Guidance Documents, and Best Practices that apply, there
are other factors/variables that affect what needs to be done in a specific Computer System
Validation:
1. The type of software that is being validated, e.g. Information Management,
Business System, PLC or SCADA, Process Control, Platform/Infrastructure,
etc. must be considered. GAMP defines categories of software and the
validation strategies that correspond to these categories.
2. Whether the software is off-the-shelf, configurable or custom developed
impacts the Validation. The more customized the software, the more
comprehensive the Validation due to the deep involvement the User should
have in the supplier’s software development processes.
3. In addition to performing Validations on computer systems that are brand new
to the organization, a company may need to perform a validation on an existing
legacy system that has never been validated. (a “retrospective” validation).
Also; a significant change to a previously validated system may require a
“revalidation”. An individual Life Science company may establish slightly
different approaches for prospective validations, retrospective validations, and
revalidations.
4. Business and Compliance Risks associated with the specific Computer System
should be used to determine validation priorities. Validations (and the
associated testing, in particular) should focus on the areas with the highest
risks.
5. Page 5 of 8
A Typical Computer System Validation
As discussed in the previous section, Computer System Validation is definitely not a “one size fits
all” procedure; the approach that an individual company may take to a specific Validation depends
on the rules, guidance, best practices, and characteristics of the system being validated. On the
other hand there are some strong similarities between the activities in most Computer System
Validations and the type of documentation produced. In fact one way to get a good understanding
of Computer System Validation is to take a look at the type of documents that would be
accumulated [see reference 9, for example]. The following is a list of the documents that might
result from the Validation of a Computer System application to be used in a GxP sensitive
environment2
:
Document Name Function of Document in Validation
User requirements Specification (URS) Defines clearly and precisely what the User wants the
system to do and states any constraints (e.g.
regulatory) under which the system must operate.
Validation Plan Defines the objectives of the Validation and the
activities, procedures and responsibilities for
accomplishing the objectives of the Validation. The
Validation Plan should also deal with the approach
for maintaining the Validation status This will
generally involve referencing the organization’s
Quality Management System documentation that
deals with such issues as Configuration Management,
Change Control, and System
Retirement.
Project plan Details the tasks and time line for the project.
Documentation justifying Selection of
System including Supplier Audit Report
Outlines the reasons for choosing the system
including the results of auditing the supplier’s quality
management system
Functional Specifications Detailed specifications showing the functions that the
system performs
Design Specifications Detailed specification showing how the system
performs the functions documented in the
Functional Specifications
Supplier Test Plans and Results Documentation of Supplier Testing
Task Reports Documentation of Design/Specification/Testing
Reviews, Walkthroughs, and Inspections
2
If associated equipment and instruments were involved, additional documents would be generated
documenting aspects of the hardware qualification and commissioning.
6. Page 6 of 8
Traceability Matrix Analysis document that shows mapping between
URS, Functional Specs, Design Specs and test cases
in IQ, OQ, PQ (see below)
Risk Assessments A Risk Assessment (sometimes called Failure Mode
and Effects Analysis), is an analysis of failure
scenarios associated with each of the functions and
sub functions of a system. Each failure scenario is
examined for potential business impact and
likelihood of occurrence in order to determine the
relative risks associated with each function and sub
function of the system. Risk assessments may need to
be performed at multiple strategic points in the
SDLC.
Network and Infrastructure Qualification Documentation that shows that the network and
infrastructure hardware/software supporting the
application System being validated has been installed
correctly and is functioning as intended [10]
Installation Qualification (IQ) Scripts and
Results
• Test cases for checking that System has been
installed correctly in User environment
• Results of executing scripts
• Deviations from expected results (if any)
Operational Qualification (OQ) Scripts and
Results
• Test cases for checking that System does what it
is intended to do in User environment
• Results of executing scripts
• Deviations from expected results (if any)
SOPs (Standard Operating Procedures),
Training Material, and Training Records
Documented procedures for users, system
administrators, and IT related functions such as
Backup & Restore and Archiving. Training records
must be kept to show the appropriate people were
trained in the correct operation of the system.
Performance Qualification (PQ) Scripts and
Results
• Test cases for checking that System does what it
is intended to do with trained people following
SOPs in the production environment even under
worst case conditions
• Results of executing scripts
• Deviations from expected results (if any)
Validation Report The Validation Report includes:
• A review of all activities and documents against
the Validation Plan
• evidence that deviations (if any) have been
addressed and the system is validated
• the plan for ongoing activities to maintain
validation status
7. Page 7 of 8
Relationship Between Computer System Validation and 21 CFR Part 11
In 1997, the FDA added rule 21 CFR Part 11 to the Code of Federal Regulations [11]. This
regulation introduces specific controls on the use of electronic records and includes strict
administrative controls on electronic signatures. These controls deal with:
1. Making electronic records suitable for supplanting paper records.
2. Making an electronic signature as secure and legally binding as a handwritten signature.
Regardless of whether or not a company uses electronic signatures, 21 CFR Part 11 impacts all
companies that use computer systems that create records in electronic form associated with the
GxP environment [12]. All computer systems in this category must have technical and
administrative controls to ensure:
1. The ability to generate accurate and complete copies of records
2. The availability of time-stamped audit trails
3. The protection of records to enable accurate and ready retrieval
4. Appropriate system access and authority checks are enforced
From the point of view of Computer System Validation, 21 CFR Part 11 has two key impacts. First,
it affirms that the FDA expects all computerized systems with GxP electronic records to be
validated (just in case this was not obvious before). Secondly, 21 CFR Part 11 says that when you
do a Validation of a particular Computer System, items 1 through 4 above automatically become
part of the requirements for the System. This means that every Computer System Validation must
assess whether the system being validated satisfies requirements 1 through 4 above and must
identify deviations, if any, and corrective actions. Since FDA regulated companies are anxious to
avoid deviations in their Validations wherever possible, most companies in the Life Science sector
are currently in a proactive mode of assessing all of their systems for 21 CFR Part 11 compliance
and addressing deviations through procedural remediation, technical remediation (e.g. software
upgrades), or replacement of non-compliant systems with 21 CFR Part 11 compliant systems.
Summary and Conclusions
A Computer System Validation is a set of activities that FDA Regulated companies must conduct
for each of their GxP sensitive computer systems. The objective of these activities is to document
evidence that each computer system will fulfill its intended purpose in a GxP production,
laboratory, or research operation. The intention is to avoid software problems that could have
serious impact. Dynamic testing of the software is an important part of the Computer System
Validation. But Computer System Validation is more than just this type of testing. Computer
System Validation requires a comprehensive set of equally important static testing activities that
need to be conducted throughout the SDLC. This includes a variety of analyses, audits,
walkthroughs, reviews, and traceability exercises. Documentation must be accumulated that
demonstrates that these activities have been performed effectively.
8. Page 8 of 8
Figure 1
“V” Diagram
Figure 2
Computer System Validation in
FDA Regulated Industries
Perform
Performance
Qualification
Identify
User Needs
Define
Requirements
Design
System
Build
System
Perform
Unit Testing
Perform
Integration
Testing
Perform
System
Testing
Perform
User Testing
Create User
Requirement
Specifications (URS)
Define
Functional
Specifications
Design
System
Build
System
Perform
Unit Testing
Perform
Integration
Testing
Perform
System Testing
Perform
Installation
Qualification
Perform
Operational
Qualification
= User has primary responsibility
= Supplier has primary
responsibility but User involved
(deeply involved for custom
development) and responsible
for documenting
evidence of quality