The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records
The document discusses validation of computerized systems used in the pharmaceutical industry. It outlines the importance of validation to ensure accuracy, reliability and consistent performance. The key aspects covered include validation protocols, qualification of hardware and software, user requirements, change control, and compliance with regulations like 21 CFR Part 11 and guidance like GAMP 5. The overall goal of validation is to confirm that computer systems meet intended uses and fulfill requirements.
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.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
The document discusses analytical instrument qualification, including the revision of USP chapter 1058. It describes the qualification process which involves design qualification, installation qualification, operational qualification, and performance qualification. It also covers roles and responsibilities, software validation, and change control, which are important aspects of ensuring analytical instruments are qualified and performing as intended.
Complying with 21 CFR Part 11 - Understanding the role of predicate ruleJasmin NUHIC
To obtain knowledge and understanding of 21 CFR Part 11 as how it applies to you as well as be advised of consequences which may result in failing to comply with this regulation.
This document provides an overview of 21 CFR Part 11, which establishes the criteria for accepting electronic records and electronic signatures. It discusses the key milestones in developing Part 11 and provides summaries of the general provisions, requirements for electronic records and signatures, and controls for closed and open systems. It also outlines some potential issues companies may face in complying with Part 11 and emphasizes the importance of security, access controls, and audit trails for electronic records systems.
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.
The document discusses validation of computerized systems used in the pharmaceutical industry. It outlines the importance of validation to ensure accuracy, reliability and consistent performance. The key aspects covered include validation protocols, qualification of hardware and software, user requirements, change control, and compliance with regulations like 21 CFR Part 11 and guidance like GAMP 5. The overall goal of validation is to confirm that computer systems meet intended uses and fulfill requirements.
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.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
The document discusses analytical instrument qualification, including the revision of USP chapter 1058. It describes the qualification process which involves design qualification, installation qualification, operational qualification, and performance qualification. It also covers roles and responsibilities, software validation, and change control, which are important aspects of ensuring analytical instruments are qualified and performing as intended.
Complying with 21 CFR Part 11 - Understanding the role of predicate ruleJasmin NUHIC
To obtain knowledge and understanding of 21 CFR Part 11 as how it applies to you as well as be advised of consequences which may result in failing to comply with this regulation.
This document provides an overview of 21 CFR Part 11, which establishes the criteria for accepting electronic records and electronic signatures. It discusses the key milestones in developing Part 11 and provides summaries of the general provisions, requirements for electronic records and signatures, and controls for closed and open systems. It also outlines some potential issues companies may face in complying with Part 11 and emphasizes the importance of security, access controls, and audit trails for electronic records systems.
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.
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
QUALIFICATION OF MANUFACTURING EQUIPMENT ehtesham-1.pptxEhtesham
This document discusses the qualification of manufacturing equipment, specifically dry powder mixers and fluid bed dryers. It describes the types of dry powder mixers and outlines the design, installation, operational, and performance qualification processes. These include verifying specifications, proper installation, operating parameters, and effectiveness of the equipment. Qualification ensures the equipment is installed correctly and operates as expected to mix ingredients uniformly and dry materials to the required moisture content.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
This document discusses computer system validation and 21 CFR Part 11 requirements for electronic records and signatures. It provides definitions of key terms from Part 11 such as electronic record, electronic signature, closed system and open system. It also summarizes the controls required by Part 11 for closed and open systems, including validation, audit trails, limiting access, documentation controls and more. The purpose is to ensure electronic records and signatures are trustworthy and equivalent to paper records.
In this slide contains definition, validation method of HVAC
Presented by: V NABI RASOOL (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur.
This document discusses equipment qualification, which involves verifying through inspections and tests that critical equipment can satisfy product quality requirements and is properly operated and maintained. It is a regulatory requirement and includes design qualification, installation qualification, operational qualification, and performance qualification. Design qualification verifies a design is suitable, installation qualification verifies proper installation, operational qualification verifies performance within operating ranges, and performance qualification verifies effective and reproducible performance of connected equipment and systems based on approved processes. The document provides details on the stages, requirements, and documentation for each type of qualification.
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. GMP aims to ensure quality standards are consistently met from starting materials to finished products. Key aspects of GMP include maintaining clean facilities, validated manufacturing processes, trained staff, comprehensive record keeping, and compliance with regulations. Strict adherence to GMP is important for patient safety, supply reliability, and international drug approval.
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.
21 CFR Part 11 is a U.S. federal regulation that specifies FDA guidelines for electronic records and signatures. It requires companies regulated by the FDA to implement controls to ensure the integrity of electronic records and signatures that are equivalent to paper records. The regulation has 3 subparts that establish requirements for electronic records in closed and open systems, electronic signature components and controls, and controls for identification codes and passwords used for electronic signatures.
The document outlines various quality management topics and provides an index with page numbers for each topic. Some of the key topics covered include: site master file, validation master plan, quality manual, change control, deviation, market complaint, product recall, CAPA, process validation, stability studies, analytical method validation, training, and regulatory updates. The index provides high-level descriptions and intended purpose for each topic and guides the reader to the relevant page numbers for more detailed information.
This document discusses pharmaceutical quality audits. It begins by defining quality audits and their purpose in verifying quality management systems and identifying areas for improvement. It then describes the three main types of quality audits: internal audits conducted within a company, external audits conducted by customers on suppliers, and regulatory audits conducted by independent bodies. The document outlines the objectives, management, responsibilities, planning process, information gathering techniques, administration, and classification of deficiencies for quality audits. It concludes that quality audits can benefit companies by evaluating quality systems and determining if processes and products meet requirements.
Este documento describe el sistema HACCP (Análisis de Peligros y Puntos Críticos de Control), incluyendo su origen, principios, análisis de peligros, puntos de control crítico, medidas de control, monitoreo, acciones correctivas y sistema de documentación. El objetivo del HACCP es prevenir riesgos asociados con el consumo de alimentos a través de un enfoque sistemático para identificar y controlar puntos críticos en la producción de alimentos.
The document discusses air-based hazards and fire protection. It describes various sources of air pollution like combustion of fuels, industrial processes, and natural sources. Specific pollutants from these sources like carbon monoxide, heavy metals, nitrogen oxides, and particulate matter are discussed. The effects of air hazards like smog, soot, greenhouse gases, and pollen are also summarized. The document then covers air circulation maintenance in sterile and non-sterile areas, preliminary hazard analysis procedures, and classifications of fire.
This document discusses 21 CFR Part 11, which sets criteria for electronic records, signatures, and computer systems used in clinical trials. It covers regulatory requirements, validation concepts and processes, roles in computerized system validation, and related FDA guidance. Warning letters and common questions about 21 CFR Part 11 are also mentioned.
This document discusses the need for high-quality water in pharmaceutical manufacturing. It notes that water is used directly and indirectly in products and cleaning. It then outlines the goals of understanding water quality systems, sources, and validation/qualification requirements. Various water treatment techniques are explained including filtration, softening, reverse osomosis and more. Validation involves proving the engineering design, operating procedures and maintenance plans. The presentation covers installation qualification, operational qualification, and performance qualification testing over multiple phases to verify long-term control of water systems.
This document discusses the qualification of gas chromatography. It begins with an introduction to gas chromatography and its use in analytical chemistry. It then discusses the different types of qualifications including design qualification, installation qualification, operational qualification, and performance qualification. Design qualification ensures the instrument is designed properly. Installation qualification confirms proper installation. Operational qualification verifies the instrument operates as expected through tests of precision, accuracy, and other parameters. Performance qualification examines the instrument's ability to provide expected results. The document provides details on tests and acceptance criteria for each qualification type to ensure the gas chromatography instrument is functioning as intended.
Computerized system validation (CSV) as a requirement for good manufacturing ...Ahmed Hasham
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.
Critical hazard management system hasm presentationAmruta Balekundri
This document discusses fire and explosion hazard management. It describes the fire triangle, which states that fire needs fuel, oxygen and an ignition source. It also discusses 8 critical risk factors that can lower ignition energy or expand flammable ranges. The document outlines controls like purging or containment of fuels, isolation of oxygen sources, and reducing energy levels. It recommends prevention plans for operations using oxygen or introducing ignition sources. The fire and explosion hazard management process involves identifying hazards, assessing risks, controlling risks, evaluating controls, and keeping records. Corporations, supervisors and workers all have roles in training, hazard identification and challenging unsafe work.
21 CFR Part 11
- Introduction
- Part 11: Electronic Records & Electronic Signatures :-
Subpart A - General Provisions
Subpart B - Electronic Records Subpart C – Electronic Signatures Good Manufacturing Practices Quality Management Documentation
- Range of requirements for written procedures Standard operating procedures (SOPs)
- Format for standard operating procedures (SOPs) Forms for recording data
- Master formulae
- References
Thank you !!!
21 CFR Part 11 outlines FDA regulations for electronic records and electronic signatures. It requires that electronic records be trustworthy, reliable, and equivalent to paper records. It also requires that electronic signatures be equivalent to handwritten signatures. The document then outlines the key subparts and sections of 21 CFR Part 11, including requirements for controls on closed and open systems, electronic signature components and controls, and validation of electronic records and signatures.
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
QUALIFICATION OF MANUFACTURING EQUIPMENT ehtesham-1.pptxEhtesham
This document discusses the qualification of manufacturing equipment, specifically dry powder mixers and fluid bed dryers. It describes the types of dry powder mixers and outlines the design, installation, operational, and performance qualification processes. These include verifying specifications, proper installation, operating parameters, and effectiveness of the equipment. Qualification ensures the equipment is installed correctly and operates as expected to mix ingredients uniformly and dry materials to the required moisture content.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
This document discusses computer system validation and 21 CFR Part 11 requirements for electronic records and signatures. It provides definitions of key terms from Part 11 such as electronic record, electronic signature, closed system and open system. It also summarizes the controls required by Part 11 for closed and open systems, including validation, audit trails, limiting access, documentation controls and more. The purpose is to ensure electronic records and signatures are trustworthy and equivalent to paper records.
In this slide contains definition, validation method of HVAC
Presented by: V NABI RASOOL (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur.
This document discusses equipment qualification, which involves verifying through inspections and tests that critical equipment can satisfy product quality requirements and is properly operated and maintained. It is a regulatory requirement and includes design qualification, installation qualification, operational qualification, and performance qualification. Design qualification verifies a design is suitable, installation qualification verifies proper installation, operational qualification verifies performance within operating ranges, and performance qualification verifies effective and reproducible performance of connected equipment and systems based on approved processes. The document provides details on the stages, requirements, and documentation for each type of qualification.
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. GMP aims to ensure quality standards are consistently met from starting materials to finished products. Key aspects of GMP include maintaining clean facilities, validated manufacturing processes, trained staff, comprehensive record keeping, and compliance with regulations. Strict adherence to GMP is important for patient safety, supply reliability, and international drug approval.
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.
21 CFR Part 11 is a U.S. federal regulation that specifies FDA guidelines for electronic records and signatures. It requires companies regulated by the FDA to implement controls to ensure the integrity of electronic records and signatures that are equivalent to paper records. The regulation has 3 subparts that establish requirements for electronic records in closed and open systems, electronic signature components and controls, and controls for identification codes and passwords used for electronic signatures.
The document outlines various quality management topics and provides an index with page numbers for each topic. Some of the key topics covered include: site master file, validation master plan, quality manual, change control, deviation, market complaint, product recall, CAPA, process validation, stability studies, analytical method validation, training, and regulatory updates. The index provides high-level descriptions and intended purpose for each topic and guides the reader to the relevant page numbers for more detailed information.
This document discusses pharmaceutical quality audits. It begins by defining quality audits and their purpose in verifying quality management systems and identifying areas for improvement. It then describes the three main types of quality audits: internal audits conducted within a company, external audits conducted by customers on suppliers, and regulatory audits conducted by independent bodies. The document outlines the objectives, management, responsibilities, planning process, information gathering techniques, administration, and classification of deficiencies for quality audits. It concludes that quality audits can benefit companies by evaluating quality systems and determining if processes and products meet requirements.
Este documento describe el sistema HACCP (Análisis de Peligros y Puntos Críticos de Control), incluyendo su origen, principios, análisis de peligros, puntos de control crítico, medidas de control, monitoreo, acciones correctivas y sistema de documentación. El objetivo del HACCP es prevenir riesgos asociados con el consumo de alimentos a través de un enfoque sistemático para identificar y controlar puntos críticos en la producción de alimentos.
The document discusses air-based hazards and fire protection. It describes various sources of air pollution like combustion of fuels, industrial processes, and natural sources. Specific pollutants from these sources like carbon monoxide, heavy metals, nitrogen oxides, and particulate matter are discussed. The effects of air hazards like smog, soot, greenhouse gases, and pollen are also summarized. The document then covers air circulation maintenance in sterile and non-sterile areas, preliminary hazard analysis procedures, and classifications of fire.
This document discusses 21 CFR Part 11, which sets criteria for electronic records, signatures, and computer systems used in clinical trials. It covers regulatory requirements, validation concepts and processes, roles in computerized system validation, and related FDA guidance. Warning letters and common questions about 21 CFR Part 11 are also mentioned.
This document discusses the need for high-quality water in pharmaceutical manufacturing. It notes that water is used directly and indirectly in products and cleaning. It then outlines the goals of understanding water quality systems, sources, and validation/qualification requirements. Various water treatment techniques are explained including filtration, softening, reverse osomosis and more. Validation involves proving the engineering design, operating procedures and maintenance plans. The presentation covers installation qualification, operational qualification, and performance qualification testing over multiple phases to verify long-term control of water systems.
This document discusses the qualification of gas chromatography. It begins with an introduction to gas chromatography and its use in analytical chemistry. It then discusses the different types of qualifications including design qualification, installation qualification, operational qualification, and performance qualification. Design qualification ensures the instrument is designed properly. Installation qualification confirms proper installation. Operational qualification verifies the instrument operates as expected through tests of precision, accuracy, and other parameters. Performance qualification examines the instrument's ability to provide expected results. The document provides details on tests and acceptance criteria for each qualification type to ensure the gas chromatography instrument is functioning as intended.
Computerized system validation (CSV) as a requirement for good manufacturing ...Ahmed Hasham
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.
Critical hazard management system hasm presentationAmruta Balekundri
This document discusses fire and explosion hazard management. It describes the fire triangle, which states that fire needs fuel, oxygen and an ignition source. It also discusses 8 critical risk factors that can lower ignition energy or expand flammable ranges. The document outlines controls like purging or containment of fuels, isolation of oxygen sources, and reducing energy levels. It recommends prevention plans for operations using oxygen or introducing ignition sources. The fire and explosion hazard management process involves identifying hazards, assessing risks, controlling risks, evaluating controls, and keeping records. Corporations, supervisors and workers all have roles in training, hazard identification and challenging unsafe work.
21 CFR Part 11
- Introduction
- Part 11: Electronic Records & Electronic Signatures :-
Subpart A - General Provisions
Subpart B - Electronic Records Subpart C – Electronic Signatures Good Manufacturing Practices Quality Management Documentation
- Range of requirements for written procedures Standard operating procedures (SOPs)
- Format for standard operating procedures (SOPs) Forms for recording data
- Master formulae
- References
Thank you !!!
21 CFR Part 11 outlines FDA regulations for electronic records and electronic signatures. It requires that electronic records be trustworthy, reliable, and equivalent to paper records. It also requires that electronic signatures be equivalent to handwritten signatures. The document then outlines the key subparts and sections of 21 CFR Part 11, including requirements for controls on closed and open systems, electronic signature components and controls, and validation of electronic records and signatures.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
The document discusses the FDA's 21 CFR Part 11 regulation on electronic records and signatures. It provides definitions and terminology used in the regulation. The regulation requires three levels of control - administrative, procedural, and technical. It also contains two major subparts on electronic records and electronic signatures. Tables 1 and 2 show how the ComplianceWire system addresses the specific requirements for electronic records and signatures outlined in the two subparts. The purpose is to help FDA-regulated industries quickly and cost-effectively comply with 21 CFR Part 11.
21 CFR Part 11, commonly referred to as “Part 11” is a set of rules that specifies what is required for electronic records and signatures. The regulatory framework outlines the management of records in Electronic Quality Management Systems for Life Science and other FDA-regulated industries.
Why is it called 21 CFR Part 11?
What is 21 CFR Part 11? CFR stands for “Code of Federal Regulation.” 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.
What are the 21 CFR rules?
21 CFR Rules set out guidelines on the usages and management of electronic records as well as electronic signatures. As such, as the user of electronic data records, you are guided by 21 CFR rules so that you can have optimal benefits from the data and also act in integrity.
(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.
(c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.
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Achieving 21 Code of Federal Regulations (CFR) Part11SamuelP9
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21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA) that establishes requirements for electronic records and electronic signatures in the context of FDA-regulated industries, including pharmaceuticals, biotechnology, medical devices, and food and beverage. The regulation is titled "Electronic Records; Electronic Signatures" and is intended to ensure the reliability, integrity, and authenticity of electronic records and signatures used in FDA-regulated activities.
1) The document describes a proposed intelligent system for monitoring and controlling water quality in natural bodies of water using wireless sensor networks and unmanned autonomous vehicles.
2) The system would use sensors to monitor water quality parameters, centralized monitoring to process the data and detect pollution, and controlled UAVs to locate and remove pollution sources.
3) The document discusses two key technical challenges - sensor selection to maximize sensor network lifetime and controlling UAVs over unreliable wireless networks. It proposes algorithms adapted from literature to address these challenges.
Calibration, preventative maintenance, Asset Management in Bio-Med Applications. How to comply the FDA validation and Part 11 requirements? computer software for calibration/PM and asset management processes.
To learn about more details, please check out this article.
https://www.qualcy.com/blog/calibration-management-software-asset-management/
Fly-by-wire (FBW) systems electronically link aircraft controls to flight control surfaces, replacing mechanical cables and hydraulic lines. The document discusses the history of FBW from early electronic signaling tests in the 1950s. It describes how FBW systems work, with the pilot providing electrical inputs to a computer which then calculates and transmits commands to actuators and control surfaces. FBW systems allow for increased aircraft stability and flexibility by processing inputs from multiple sensors. While analog FBW uses analog signal processing, digital FBW performs tasks via digital computers, increasing electronic stability and simplifying circuits. FBW has been adopted in military aircraft like the F-22 and in commercial planes due to its improved accuracy and reduced mechanical wear.
This document provides guidance for digital forensic service providers on complying with codes of practice and conduct. It specifies requirements around accreditation, technical records, test methods and validation, exhibit handling, and summarizes key points from the main codes document. The guidance is a consultation draft and comments are being accepted until March 10, 2013.
Circuit breakers (CBs) are very important elements in the power system. They are used to switch other equipment in and out of service. Circuit breakers need to be reliable since their incorrect operation can cause major issues with power system protection and control. Today’s practice in monitoring circuit breaker operation and status in real time is reduced to the use of Remote Terminal Units (RTUs) of Supervisory Control and Data Acquisition (SCADA) system to assess CB status. More detailed information about the control circuit performance may be obtained by CB test equipment typically used for maintenance diagnostics. This paper addresses two important issues: a) how improved CB monitoring may be implemented in real-time, and b) what would be the benefits of such an implementation. The results reported in this paper are coming from two research projects, conducted using funding from Center Point Energy and DOE-CERTS aimed at development of software for automated analysis of CB data and the other covering development of the CB data acquisition unit respectively. The paper is devoted to description of a prototype implementation of a real-time CB monitoring system. The system consists of a new CB monitoring data acquisition IED that is located at circuit breaker and captures detailed information about its operation in real-time. The CB files are transferred to the concentrator PC where the application software performs automated analysis and makes an assessment about the operational status of the breaker. The software is based on signal processing and expert system processing. Application example using actual field data is discussed the paper ends with some conclusions, acknowledgments and a list of references.
The document discusses the role of Waters Empower Software in assisting companies with 21 CFR Part 11 compliance. 21 CFR Part 11 is the FDA's rule governing electronic records and electronic signatures, which has significant implications for regulated life science industries. The summary discusses how Empower Software provides technical controls to help meet the requirements of 21 CFR Part 11, including accurately archiving and retrieving machine-readable and human-readable data, limiting system access through login credentials, capturing audit trails of user actions, and employing role-based privileges to control system access. Empower Software is presented as a tool to help life science companies achieve compliance with 21 CFR Part 11.
The document discusses the role of Waters Empower Software in assisting companies with 21 CFR Part 11 compliance. 21 CFR Part 11 is the FDA's rule governing electronic records and electronic signatures, which has significant implications for regulated life science industries. The summary discusses how Empower Software provides technical controls to help meet the requirements of 21 CFR Part 11, including accurately archiving and retrieving machine-readable and human-readable data, limiting system access through login credentials, capturing audit trails of user actions, and employing role-based privileges to control system access. Empower Software is presented as a tool to help life science companies achieve compliance with 21 CFR Part 11.
IRJET - Implementation of VPN, AWS Cloud Enabled Real Time Water Pollution Sy...IRJET Journal
This document discusses the implementation of a real-time water pollution monitoring system using a virtual private network (VPN) and Amazon Web Services (AWS) cloud. The system uses sensors to monitor water quality parameters like pH, temperature, turbidity, and water level. The sensor data is transmitted wirelessly via an ESP8266 Wi-Fi module to a microcontroller and then to the cloud. The system aims to allow remote access to water quality monitoring in real-time and help identify pollutants, addressing issues with traditional manual water testing methods. VPN technology is used to securely transmit the sensor data between different networks by creating private, encrypted connections.
This document describes a Remote Mechanical Ventilation Manager (RMVM) that enables remote monitoring of mechanical ventilator data. The RMVM uses a database of device-specific commands to extract data from ventilators via serial interfaces. It then processes and displays the data through a web-based user interface. The RMVM framework supports multiple ventilator models by referencing their unique command syntax stored in the database. This allows clinicians to remotely view patient ventilation data through a standardized interface without needing different monitoring applications for each ventilator type.
A CAN BUS BASED SYSTEM FOR MONITORING AND FAULT DIAGNOSIS IN WIND TURBINE Own preparations
A CAN based architecture is designed for the purpose of intensive monitoring and fault diagnosis in wind turbine. It provides a full automation system. CAN (Controller Area Network) Bus is a high speed serial data bus with high transmission rate. CAN Bus interface technique with an integration of electro-mechanical subsystems that embeds network control systems is proposed along with ARM controller to monitor and diagnose the problems in the wind turbine application. CAN BUS will enable the data transmission between two units at the same time without any disturbances. The transmission time of data is decreased with this CAN protocol. ARM core1 (LPC2148) interfaced with CAN transceiver and wind turbine sensing units. ARM core2 is interfaced with fault diagnose and monitoring section. Weather Condition (WC) monitoring and Generation Voltage (GV) display is also added in this design. Data acquisition node collects the sensed data through CAN protocol. This technique reduces the possibility of fault and increase the monitoring of wind turbine.
This document discusses the history and development of fly-by-wire (FBW) systems. It notes that electronic signaling of aircraft controls was tested in the 1950s and the first digital FBW aircraft flew in 1972. A FBW system uses an electronic interface between pilot controls and actuators, with a computer modifying manual inputs based on other parameters. The document outlines the components of a FBW system, including sensors, controllers, and actuators. It compares analog and digital FBW systems, noting increased flexibility and stability with digital. Several advanced aircraft like the F-22 Raptor use FBW technology.
A Survey on Smart DRIP Irrigation SystemIRJET Journal
This document summarizes a survey on a proposed smart drip irrigation system. The key points are:
1) The proposed system uses sensors to monitor soil conditions and weather. It sends this data to an Android app via a base station to allow remote control and monitoring of the irrigation system.
2) The smart system aims to automate irrigation based on environmental conditions rather than schedules, reducing water use and increasing crop yields.
3) Researchers believe this Internet of Things approach could make irrigation more efficient and beneficial for farmers by allowing remote control from any location.
Effect of fuzzy PID controller on feedback control systems based on wireless ...IJECEIAES
Wireless Networked control system (WNCS) has an important in all aspects of the life and in the research fields of Engineering. In this article, a real-time implementation of the wireless feedback control system (WFCS) is performed. The stability issue in the closed-loop control system still suffer from noise, disturbances, and need careful considerations to handle it. Three cases to discover the ability of a Fuzzy PID controller to maintain better angular position control system (PCS) is addressed and controlled by a personal computer through a wireless sensor network(WSN) constructed by ZigBee platforms. The practical issues related with the design and implementation of the wireless computerized control system (WCCS) is discussed and analyzed. The simulation results carried out with Matlab/ Simulink 2018b. Different parameters effect such as maximum overshoot, sampling frequency, distance and delay time have been studied. These effects on overall system performance would be discussed. Improving the efficient use of ZigBee platform for WFCS. The simulation and experimental results prove the proposed algorithm in the field of wireless control system.
Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.
The document provides an overview of the New Drug Application (NDA) process. It discusses that an NDA is required for approval to market a new drug in the US. The goals of an NDA are to demonstrate a drug's safety, efficacy, appropriate labeling, and quality manufacturing. An NDA contains extensive data from non-clinical and clinical trials. It follows a common technical document format and is reviewed by the FDA to determine if the drug's benefits outweigh the risks for approval.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are copyrights, patents, trademarks, and trade secrets. The modern concept of intellectual property developed in England in the 17th and 18th centuries. The term "intellectual property began to be used in the 19th century, though it was not until the late 20th century that intellectual property became commonplace in the majority of the world's legal systems. The main purpose of intellectual property law is to encourage the creation of a wide variety of intellectual goods. To achieve this, the law gives people and businesses property rights to the information and intellectual goods they create, usually for a limited period of time. This gives economic incentive for their creation, because it allows people to benefit from the information and intellectual goods they create, and allows them to protect their ideas and prevent copying. These economic incentives are expected to stimulate innovation and contribute to the technological progress of countries, which depends on the extent of protection granted to innovators.
drug industry location and design is considered while designing facility and premises for manufacturing of drug as per the GMP and CGMP regulations. many environmental factores affects safety efficacy and quality of drugs those factores are considerd while designing the manufacturing industry
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical
Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its
manufacturing process. It is first produced for the original marketing application and
can be updated to support new knowledge gained over the lifecycle of a product. The
Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. e ICH Q1A guideline and defines the
stability data package for a new drug substance or drug product that is sufficient for
a registration application within the three regions of the EC, Japan, and the United States. It does not seek necessarily to cover the testing for registration in or export to other areas of the world. The guideline seeks to exemplify the core stability data package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative
approaches can be used when there are scientifically justifiable reasons.
National Accreditation Board for Testing and Calibration Laboratories (NABL) provides accreditation to Conformity Assessment Bodies (Laboratories) in India. NABL Schemes include Accreditation (Recognition) of Technical competence of testing, calibration, medical testing laboratories, Proficiency testing providers (PTP) & Reference Material Producers (RMP) for a specific scope following ISO/IEC 17025, ISO 15189, ISO/IEC 17043[2] & ISO 17034:2016 Standards. It has Mutual Recognition Arrangement (MRA) with Asia Pacific Laboratory Accreditation Cooperation (APLAC), International Laboratory Accreditation Cooperation (ILAC).
NABL is a constituent board of Quality Council of India which is an autonomous body setup under Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, Government of India.
Potentiometry is one of the methods of electroanalytical chemistry. It is usually employed to find the concentration of a solute in solution. In potentiometric measurements, the potential between two electrodes is measured using a high impedance voltmeter An ion-selective electrode (ISE), also known as a specific ion electrode (SIE), is a transducer (or sensor) that converts the activity of a specific ion dissolved in a solution into an electrical potential. There are four main types of ion-selective membrane used in ion-selective electrodes (ISEs): glass, solid state, liquid based, and compound electrode.
Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) CurriculumMJDuyan
(𝐓𝐋𝐄 𝟏𝟎𝟎) (𝐋𝐞𝐬𝐬𝐨𝐧 𝟏)-𝐏𝐫𝐞𝐥𝐢𝐦𝐬
𝐃𝐢𝐬𝐜𝐮𝐬𝐬 𝐭𝐡𝐞 𝐄𝐏𝐏 𝐂𝐮𝐫𝐫𝐢𝐜𝐮𝐥𝐮𝐦 𝐢𝐧 𝐭𝐡𝐞 𝐏𝐡𝐢𝐥𝐢𝐩𝐩𝐢𝐧𝐞𝐬:
- Understand the goals and objectives of the Edukasyong Pantahanan at Pangkabuhayan (EPP) curriculum, recognizing its importance in fostering practical life skills and values among students. Students will also be able to identify the key components and subjects covered, such as agriculture, home economics, industrial arts, and information and communication technology.
𝐄𝐱𝐩𝐥𝐚𝐢𝐧 𝐭𝐡𝐞 𝐍𝐚𝐭𝐮𝐫𝐞 𝐚𝐧𝐝 𝐒𝐜𝐨𝐩𝐞 𝐨𝐟 𝐚𝐧 𝐄𝐧𝐭𝐫𝐞𝐩𝐫𝐞𝐧𝐞𝐮𝐫:
-Define entrepreneurship, distinguishing it from general business activities by emphasizing its focus on innovation, risk-taking, and value creation. Students will describe the characteristics and traits of successful entrepreneurs, including their roles and responsibilities, and discuss the broader economic and social impacts of entrepreneurial activities on both local and global scales.
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
This presentation was provided by Rebecca Benner, Ph.D., of the American Society of Anesthesiologists, for the second session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session Two: 'Expanding Pathways to Publishing Careers,' was held June 13, 2024.
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
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Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
A Visual Guide to 1 Samuel | A Tale of Two HeartsSteve Thomason
These slides walk through the story of 1 Samuel. Samuel is the last judge of Israel. The people reject God and want a king. Saul is anointed as the first king, but he is not a good king. David, the shepherd boy is anointed and Saul is envious of him. David shows honor while Saul continues to self destruct.
The chapter Lifelines of National Economy in Class 10 Geography focuses on the various modes of transportation and communication that play a vital role in the economic development of a country. These lifelines are crucial for the movement of goods, services, and people, thereby connecting different regions and promoting economic activities.
This document provides an overview of wound healing, its functions, stages, mechanisms, factors affecting it, and complications.
A wound is a break in the integrity of the skin or tissues, which may be associated with disruption of the structure and function.
Healing is the body’s response to injury in an attempt to restore normal structure and functions.
Healing can occur in two ways: Regeneration and Repair
There are 4 phases of wound healing: hemostasis, inflammation, proliferation, and remodeling. This document also describes the mechanism of wound healing. Factors that affect healing include infection, uncontrolled diabetes, poor nutrition, age, anemia, the presence of foreign bodies, etc.
Complications of wound healing like infection, hyperpigmentation of scar, contractures, and keloid formation.
2. Quality Management System (MQA102T)
Topic: CFR-21 Part 11
Presented by
MANSI NARENDRASINH CHAUHAN
M.Pharm
Pharmaceutical Quality Assurance
Guided by:
Dr. Dulendra P. Damahe
Smt B.N.B Swaminarayan Pharmacy College Salvav-Vapi.
3. Contents
Introduction
Background
CFR-21 Part 11
Subpart A: general provisions
◦ 11.1-Scope
◦ 11.2-Implementation
◦ 11.3-Defination
Subpart B: electronic records
o11.10-Control for closed system
o11.30-Control for open system
o11.50 Signature manifestations
o11.70-Signature/record linking
Subpart C: electronic signature
o11.100-General requirement
o11.200-Electronic signature components
o11.300- Identification codes/passwords
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4. Introduction
◦ Code of Federal Regulation is the codification of the general and
permanent rules and regulations published in the Federal Register
by the executive department and agencies of the federal
government of the United States.
◦ The CFR is divided into 50 titles which represent broad areas
subject to federal regulation. Each title is divided into chapters,
subchapters, parts, and section.
◦ Title 21 concern the area of Food and Drug, Chapter 1 is related to
FDA, Part 11is the sub-section of this chapter it focuses on a
specific area ( i.e., Electronic Record; Electronic Signature).
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5. Background
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◦ In March of 1997, FDA issued final part 11 regulations that
provide criteria for acceptance by FDA, under certain
circumstances, of electronic records, electronic signatures, and
handwritten signatures executed to electronic records as
equivalent to paper records and handwritten signatures
executed on paper. These regulations, which apply to all FDA
program areas, were intended to permit the widest possible use
of electronic technology, compatible with FDA's responsibility
to protect the public health.
6. CFR-21 PART 11
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ELECTRONIC RECORDS ELECTRONIC
SIGNATURE
Validation
Glossary of
Terms
Time Stamps
Maintenance
of Electronic
Records
Electronic
Copies of
Electronic
Records
Draft guidance documents
7. Part 11 : Electronic Records; Electronic
Signatures
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Subpart A:
General
Provisions
Subpart B:
Electronic
Records
Subpart C:
Electronic
signatures
11.1-Scope
11.2-Implementation
11.3-Defination
11.10-Control for closed system
11.30-Control for open system
11.50 Signature manifestations
11.70-Signature/record linking
11.100-General requirement
11.200-Electronic signature components
11.300- Identification codes/passwords
9. 11.1 - SCOPE
◦ The regulations in this part set the criteria under which the agency
considers Electronic records to be trustfully, reliable, and generally
equivalent to paper records.
◦ This part applies to Records in electronic form that are created, modified,
maintained, archived, retrieved, or transmitted.
◦ Electronic signatures to be equivalent to handwritten signatures, and
other general signing.
◦ Electronic records may be use in place of paper records.
◦ Computer systems (including hardware and software), controls, and
attendant documentation maintained under this part shall be readily
available for, and subject to, FDA inspection.
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10. 11.2 - Implementation
A. For records required to be maintained but not submitted to the agency,
persons may use electronic records in place of paper records or electronic
signatures rather than traditional signatures, in whole or in part, provided that
the requirements of this part are met.
B. For record submitted to agency The document or parts of a document to be
submitted have been identified in public docket No. 92S-0251 as being the
type of submission the agency accepts in electronic form. This docket will
identify specifically what types of documents or parts of documents are
acceptable for submission in electronic form without paper records and the
agency receiving unit(s)
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11. 11.3 - Definition
Electronic record- combination of text, graphics, data, audio, pictorial,
or other information represent digital form it is modified.
Electronic signature- computer data of any symbol executed by an
individual to be the individual written signature.
Digital signature- electronic signature base on cryptographic method.
Handwritten signature- the act of signing with a writing or marking
instrument such as pen is preserved.
Biometrics- verifying individual identity base on individual physical
feature or action are both unique to that individual.
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13. 11.10 - Control for closed system
o Persons who use closed systems to create, modify, maintain, or
transmit electronic records shall employ procedures and
controls designed to ensure the authenticity, integrity, and,
when appropriate, the confidentiality of electronic records, and
to ensure that the signer cannot readily repudiate the signed
record as not genuine.
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14. (a) Validation of systems
(b)The ability to generate accurate and complete copies of records in both human readable
and electronic form.
(c) Protection of records to enable their accurate and ready retrieval throughout the
records retention period.
(d) Limiting system access to authorized individuals.
(e) Use of secure, computer-generated, time-stamped audit trails to independently record
the date and time of operator entries and actions that create, modify, or delete electronic
records.
(f) Use of operational system checks to enforce permitted sequencing of steps and events, as
appropriate.
(g) Use of authority checks to ensure that only authorized individuals can use the system,
electronically sign a record, access the operation or computer system input or output
device, alter a record, or perform the operation at hand.
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15. (h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the
source of data input or operational instruction.
(i) Determination that persons who develop, maintain, or use electronic record/electronic
signature systems have the education, training, and experience to perform their assigned
tasks.
(j) The establishment of, and adherence to, written policies that hold individuals
accountable and responsible for actions initiated under their electronic signatures, in order
to deter record and signature falsification.
(k) Use of appropriate controls over systems documentation including:
1. Adequate controls over the distribution of, access to, and use of documentation for
system operation and maintenance.
2. Revision and change control procedures to maintain an audit trail that documents time-
sequenced development and modification of systems documentation.
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16. 11.30 - Control for open system
◦ Persons who use open systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, as appropriate,
the confidentiality of electronic records from the point of their
creation to the point of their receipt.
◦ Such procedures and controls shall include those identified in §
11.10, as appropriate, and additional measures such as document
encryption and use of appropriate digital signature standards to
ensure, as necessary under the circumstances, record authenticity,
integrity, and confidentiality.
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17. 11.50 Signature manifestations
(a) Signed electronic records shall contain information associated with the signing that
clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with
the signature.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be
subject to the same controls as for electronic records and shall be included as part of any
human readable form of the electronic record (such as electronic display or printout).
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18. 11.70-Signature/record linking
◦ Electronic signatures and handwritten signatures executed to
electronic records shall be linked to their respective electronic
records to ensure that the signatures cannot be excised, copied,
or otherwise transferred to falsify an electronic record by
ordinary means.
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21. UNIQUE
◦ Each electronic signature shall be unique to one individual and shall not
be reused by ,or reassigned to, anyone else.
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22. VERIFY THE IDENTITY
◦ Before an organization establishes, assigns, certifies, or otherwise
individual’s electronic signature, or any element of such electronic
signature, the organization shall verify the identity of the individual.
◦ At the time of joining that activity done by HR Department.
◦ For vendor in service agreement need to be clarification.
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23. CERTIFY TO THE AGENCY
◦ The certification shall be submitted in paper form and signed with a
traditional handwritten signature, to the Office of Regional Operations.
◦ Persons using electronic signatures shall, upon agency request,
provide additional certification that a specific electronic signature is the
legally binding equivalent of the signer’s handwritten signature
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25. Non biometrics
◦ Electronic signature that are not based upon biometric shall:
◦ Employ at least two distinct identification components such as an identification
code and password.
◦ When an individual executes a series of signing during a single , continuous
period of controlled system access, the first signing shall be executed using at
least one electronic signature that used only by ,the individual.
◦ Be used only by their genuine owners; and
◦ Be administered and executed to ensure that used of an individual’s electronic
signature by anyone other than its genuine owner requires collaboration of
two or more individuals.
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26. Biometrics
◦ Electronic signature based upon biometric shall be designed
to ensure that they cannot be used by anyone other than
their genuine owners.
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27. 11.300- Identification codes/passwords
◦ Persons who use electronic signatures based upon use of identification
code in combination with passwords shall employ control to ensure
their security and integrity. Such controls shall include: Uniqueness
Code and password Periodically Checked Periodic testing of devices.
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Uniqueness
Code and password
periodically changed
Periodic testing of devices
28. Uniqueness
◦ Maintaining the uniqueness of each combined identification code and
password , such that no two individuals have the same combination of
identification code and password.
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29. Code and password Periodically Checked
◦ Ensuring that identification code and password issuances are
periodically checked ,recalled ,or revise (e.g., to cover such events as
password aging)
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30. Periodic testing of devices
◦ Initial and periodic testing of devices, such as tokens or cards, that
bear or generate identification code or password information to ensure
that they function properly and have not been altered in an
unauthorized manner.
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31. References
1. “THE ULTIMATE GUIDE TO 21 CFR PART 11” by MARIN RICHESON – Perficient.
2. Ira R. Berry Robert P. Martin “The Pharmaceutical Regulatory Process” (2008) second edition -
Informa Healthcare USA, Inc.
3. https://www.perficient.com/-/media/files/guide-pdf-links/the-ultimate-guide-to-21-cfr-part-
11.pdf
4. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
5. https://www.govinfo.gov/app/details/CFR-2012-title21-vol1/CFR-2012-title21-vol1-sec11-200
6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11
7. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-
electronic-records-electronic-signatures-scope-and-application
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