www.3-14.com
People are still superior to machines when it comes to detecting data integrity issues, because the required level of analysis is too complex for a machines. That is why the review process remains part of the human domain.
www.3-14.com
Source Data expectations for the life sciences industry. Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.
This document discusses data integrity in pharmaceutical quality systems. It defines data and explains its importance in decision making and continual improvement. It notes that the FDA and EMA have issued warning letters and non-compliance reports for data integrity issues. Examples are provided of warning letters issued to two companies for violations like unauthorized data manipulation, lack of audit trails, and insufficient investigations. The causes of data integrity breaches are discussed. It emphasizes establishing a culture of integrity, security protocols, and complying with cGMP guidelines. It provides details on how to properly manage system access, data storage, backups, and recording data according to ALCOA principles. The importance of audit trail software is also covered.
This document discusses data integrity expectations from regulatory agencies like the TGA. It defines data integrity as ensuring data is complete, consistent and accurate throughout its lifecycle. Recent global cases of data integrity issues at drug manufacturers are presented, involving falsification of records, deletion of lab data, and lack of controls around electronic data changes. The ALCOA principles for attributable, legible, contemporaneous, original and accurate data are described. TGA expectations include manufacturers understanding their vulnerabilities, assessing data integrity risks, designing systems to prevent issues, training staff, and having ongoing review systems. Conclusions state existing quality systems should ensure data integrity and traceability, and manufacturers are responsible for preventing and detecting integrity issues.
Looking for expertise or support on Data Integrity? Contact us today.
Recently, the pharmaceutical industry has been challenged with the regulatory requirements to provide complete, consistent and accurate data, throughout all GMP regulated processes.
Moreover, during audits the regulatory bodies have observed a level of inconsistency in the application of the predicate rules in GMP processes. This has become a growing concern and has led to a set of new (draft) guidances from different market authorities.
Index:
Data Integrity – Why / What
Data life cycle
Core Data Integrity concepts & building blocks
Short & mid-term actions enabling a focused road to compliance
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Data Integrity Issues in Pharmaceutical CompaniesPiyush Tripathi
Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
www.3-14.com
Source Data expectations for the life sciences industry. Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.
This document discusses data integrity in pharmaceutical quality systems. It defines data and explains its importance in decision making and continual improvement. It notes that the FDA and EMA have issued warning letters and non-compliance reports for data integrity issues. Examples are provided of warning letters issued to two companies for violations like unauthorized data manipulation, lack of audit trails, and insufficient investigations. The causes of data integrity breaches are discussed. It emphasizes establishing a culture of integrity, security protocols, and complying with cGMP guidelines. It provides details on how to properly manage system access, data storage, backups, and recording data according to ALCOA principles. The importance of audit trail software is also covered.
This document discusses data integrity expectations from regulatory agencies like the TGA. It defines data integrity as ensuring data is complete, consistent and accurate throughout its lifecycle. Recent global cases of data integrity issues at drug manufacturers are presented, involving falsification of records, deletion of lab data, and lack of controls around electronic data changes. The ALCOA principles for attributable, legible, contemporaneous, original and accurate data are described. TGA expectations include manufacturers understanding their vulnerabilities, assessing data integrity risks, designing systems to prevent issues, training staff, and having ongoing review systems. Conclusions state existing quality systems should ensure data integrity and traceability, and manufacturers are responsible for preventing and detecting integrity issues.
Looking for expertise or support on Data Integrity? Contact us today.
Recently, the pharmaceutical industry has been challenged with the regulatory requirements to provide complete, consistent and accurate data, throughout all GMP regulated processes.
Moreover, during audits the regulatory bodies have observed a level of inconsistency in the application of the predicate rules in GMP processes. This has become a growing concern and has led to a set of new (draft) guidances from different market authorities.
Index:
Data Integrity – Why / What
Data life cycle
Core Data Integrity concepts & building blocks
Short & mid-term actions enabling a focused road to compliance
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Data Integrity Issues in Pharmaceutical CompaniesPiyush Tripathi
Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Presentation: Data Integrity – an international regulatory perspectiveTGA Australia
This presentation will provide an overview of the international regulatory perspective on data integrity and discuss some of the key points highlighted in recently released guidance documents from across the globe.
FDA Data Integrity Issues - DMS hot fixesVidyasagar P
The document discusses data integrity, including popular causes of integrity issues, consequences, and fixes related to document management systems. It provides definitions of data integrity and discusses regulatory requirements around integrity from agencies like the FDA. Specifically, it summarizes the FDA's 21 CFR Part 11 regulation, which considers electronic records equivalent to paper if certain controls are in place. It also discusses application integrity policies and concludes that ensuring data integrity is important to rebuild regulatory trust if issues are found.
The document discusses data integrity and recent regulatory approaches. It defines data integrity as the completeness, consistency, and accuracy of data throughout its lifecycle. Regulatory agencies are increasingly focused on data integrity due to its importance in ensuring product quality and safety. Common data integrity issues found by agencies include fabricated, falsified, or missing records. Ensuring data integrity requires effective quality management systems, risk management, technology solutions, and governance.
The document discusses data integrity and provides guidance on ensuring data integrity through the ALCOA principles of Attributable, Legible, Contemporaneous, Original, and Accurate. It defines each of the ALCOA principles and provides examples of their application. Common data integrity issues found by the FDA during inspections are also summarized, including data manipulation, multiple sample runs, backdated documentation, unauthorized data access, logbook recording issues, and others.
Data Integrity; Ensuring GMP Six Systems Compliance Pharma TrainingMarcep Inc.
This document outlines a two-day workshop on data integrity compliance to meet regulatory standards. The workshop will cover data integrity requirements from the FDA, EU, and other regulators; challenges in ensuring data integrity across paper, hybrid, and electronic systems; best practices for data generation, recording, transformation and reporting; and conducting risk assessments and monitoring metrics to ensure ongoing data integrity. Attendees will learn how to strengthen internal audits and compliance across their quality systems, facilities, materials management, and other areas to meet data integrity expectations.
Data integrity issues are regularly cited by global regulatory agencies in inspection reports. National cultures can influence compliance with data integrity standards due to differences in power distance, individualism, and time orientation. Regulators now specifically target data integrity during inspections and audit raw data to verify submitted information. Companies must consider cultural factors when ensuring global compliance and promote quality cultures through codes of conduct.
This presentation is based on the US FDA Workshop that I attended in Mumbai.
Pharmaceutical Industry is challenged for the Data Integrity. The reason for Data Integrity Fraud are obvious, but are overlooked. The importance of the genuine data must be accepted from the patient safety angle. There has to be a sincere attempt from the Top Management to eliminate this problem. It is trust that needs to be developed and maintained.
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
The document discusses regulatory guidance and enforcement actions around data integrity and management from USFDA, MHRA, and other agencies. It notes deficiencies seen such as shared passwords and lack of audit trails. It provides background on regulations and guidance documents around electronic records and data integrity. It discusses inspections and warning letters issued to various companies regarding data integrity issues. The document aims to help readers understand regulatory expectations around data integrity and management.
FDA's top data integrity issues during the inspectionsKiran Kota
The document discusses common data integrity issues found during FDA inspections of pharmaceutical companies. It identifies six main issues: 1) Data manipulation through altering original results to produce passing results. 2) Running analysis multiple times to get passing results and deleting failed runs. 3) Backdating documentation to conceal failed analysis. 4) Unauthorized deletion or alteration of electronic data. 5) Discrepancies between instrument logs and logbooks. 6) Passing off results from previous batches as new analysis by copying and renaming electronic data files. The FDA views these practices as violations of data integrity that call into question the quality of manufactured products.
This document discusses data integrity and its importance in the pharmaceutical industry. It defines data integrity as the extent to which all data is complete, consistent and accurate throughout its lifecycle. Regulatory agencies like the FDA and MHRA require data integrity to ensure patient safety. Lack of data integrity can result in warning letters or consent decrees from regulators. The document outlines principles like ALCOA+ to ensure data integrity. It discusses examples of data integrity issues found in warning letters and gives recommendations for proper implementation of data integrity controls and quality culture.
Data integrity Presentation@GCC Regulatory Summit April-2017Cepal & Co.
Rashid Mureed gave a presentation on regulatory challenges with data integrity and data management. He discussed global standards and guidance from organizations like WHO, EMA, MHRA, and FDA. Common deficiencies seen include a lack of audit trails, improper user access controls, and inaccurate or fabricated test results. Mureed emphasized the importance of the ALCOA principles for data integrity and explained that most issues stem from technical failures and bad practices rather than willful misconduct. He provided recommendations for developing a data integrity action plan through risk assessment, defined procedures, training, and fostering a culture of quality.
Data integrity is crucial in the pharmaceutical industry to ensure patient safety and product quality. It refers to data being complete, consistent, and accurate throughout its lifecycle, from generation to storage. Issues can arise from falsification, poor documentation practices, lack of system controls, and not reviewing for errors. To minimize risks, companies should follow good documentation practices like ALCOA+, implement audit trails and quality management systems, and conduct training and system validation. Maintaining data integrity builds trust between regulators and industry.
This document discusses data integrity and good documentation practices. It begins with an introduction to the ALCOA principles for data quality, which stand for Attributable, Legible, Contemporaneous, Original, and Accurate. It then defines data integrity and lists some common data integrity issues seen by regulators. The rest of the document outlines good documentation practices, including the importance of conforming to standards, maintaining document versions and revisions, and avoiding issues like undocumented changes. It emphasizes that poor documentation can undermine drug safety and efficacy and break regulatory trust.
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
- The document discusses data integrity, which refers to maintaining accurate and consistent data over its entire lifecycle. This is important for the regulated healthcare industry as quality decisions are based on data.
- The FDA uses the ALCOA criteria (Attributable, Legible, Contemporaneous, Original, Accurate) to define expectations for electronic data. Regulatory agencies now focus heavily on data integrity due to instances of fabricated documents and errors.
- Common data integrity issues found by agencies include non-contemporaneous recording, backdating records, re-running samples until desired results are obtained, and data fabrication. Ensuring data integrity helps prevent regulatory actions like warning letters or import bans against companies.
The document discusses FDA's expectations around data integrity and compliance with Good Manufacturing Practices (GMP). It provides clarification on key terms like data integrity, metadata, and audit trails. It also addresses FDA's expectations that firms implement strategies to manage data integrity risks in a flexible, risk-based manner. The document indicates that while electronic records and signatures are allowed, all CGMP data must be evaluated and maintained according to regulations. It concludes by answering questions to further clarify terminology.
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
The document discusses the trend toward automating phase I clinical trials. Historically, phase I trials have been largely paper-based, which has led to challenges around volunteer recruitment, complex workflows, scheduling studies, ensuring sample integrity, and accurately capturing data. However, there is a growing trend toward automating phase I trials using solutions like Oracle's LabPas in order to address these challenges, improve efficiency, and help phase I clinics and sponsors better manage costs, quality, and speed of data delivery. The document outlines key benefits and features of LabPas for automating phase I trials.
Implementing ICD-10 In Five Simple StepsHarold Gibson
M-Scribe outlines a 5-step plan for healthcare practices to implement ICD-10: 1) Planning and assessment, 2) Training, 3) Process changes, 4) Transition management, and 5) Testing. The first step involves mapping workflows, identifying gaps, and developing an implementation plan. Step 2 focuses on training staff on ICD-10 codes and documentation changes. Step 3 is updating processes like forms and policies. Step 4 is dual coding during transition and monitoring progress. The final step is testing internally and with external partners like payers. M-Scribe offers practices consultation and recommendations to help with their ICD-10 implementation.
Presentation: Data Integrity – an international regulatory perspectiveTGA Australia
This presentation will provide an overview of the international regulatory perspective on data integrity and discuss some of the key points highlighted in recently released guidance documents from across the globe.
FDA Data Integrity Issues - DMS hot fixesVidyasagar P
The document discusses data integrity, including popular causes of integrity issues, consequences, and fixes related to document management systems. It provides definitions of data integrity and discusses regulatory requirements around integrity from agencies like the FDA. Specifically, it summarizes the FDA's 21 CFR Part 11 regulation, which considers electronic records equivalent to paper if certain controls are in place. It also discusses application integrity policies and concludes that ensuring data integrity is important to rebuild regulatory trust if issues are found.
The document discusses data integrity and recent regulatory approaches. It defines data integrity as the completeness, consistency, and accuracy of data throughout its lifecycle. Regulatory agencies are increasingly focused on data integrity due to its importance in ensuring product quality and safety. Common data integrity issues found by agencies include fabricated, falsified, or missing records. Ensuring data integrity requires effective quality management systems, risk management, technology solutions, and governance.
The document discusses data integrity and provides guidance on ensuring data integrity through the ALCOA principles of Attributable, Legible, Contemporaneous, Original, and Accurate. It defines each of the ALCOA principles and provides examples of their application. Common data integrity issues found by the FDA during inspections are also summarized, including data manipulation, multiple sample runs, backdated documentation, unauthorized data access, logbook recording issues, and others.
Data Integrity; Ensuring GMP Six Systems Compliance Pharma TrainingMarcep Inc.
This document outlines a two-day workshop on data integrity compliance to meet regulatory standards. The workshop will cover data integrity requirements from the FDA, EU, and other regulators; challenges in ensuring data integrity across paper, hybrid, and electronic systems; best practices for data generation, recording, transformation and reporting; and conducting risk assessments and monitoring metrics to ensure ongoing data integrity. Attendees will learn how to strengthen internal audits and compliance across their quality systems, facilities, materials management, and other areas to meet data integrity expectations.
Data integrity issues are regularly cited by global regulatory agencies in inspection reports. National cultures can influence compliance with data integrity standards due to differences in power distance, individualism, and time orientation. Regulators now specifically target data integrity during inspections and audit raw data to verify submitted information. Companies must consider cultural factors when ensuring global compliance and promote quality cultures through codes of conduct.
This presentation is based on the US FDA Workshop that I attended in Mumbai.
Pharmaceutical Industry is challenged for the Data Integrity. The reason for Data Integrity Fraud are obvious, but are overlooked. The importance of the genuine data must be accepted from the patient safety angle. There has to be a sincere attempt from the Top Management to eliminate this problem. It is trust that needs to be developed and maintained.
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
The document discusses regulatory guidance and enforcement actions around data integrity and management from USFDA, MHRA, and other agencies. It notes deficiencies seen such as shared passwords and lack of audit trails. It provides background on regulations and guidance documents around electronic records and data integrity. It discusses inspections and warning letters issued to various companies regarding data integrity issues. The document aims to help readers understand regulatory expectations around data integrity and management.
FDA's top data integrity issues during the inspectionsKiran Kota
The document discusses common data integrity issues found during FDA inspections of pharmaceutical companies. It identifies six main issues: 1) Data manipulation through altering original results to produce passing results. 2) Running analysis multiple times to get passing results and deleting failed runs. 3) Backdating documentation to conceal failed analysis. 4) Unauthorized deletion or alteration of electronic data. 5) Discrepancies between instrument logs and logbooks. 6) Passing off results from previous batches as new analysis by copying and renaming electronic data files. The FDA views these practices as violations of data integrity that call into question the quality of manufactured products.
This document discusses data integrity and its importance in the pharmaceutical industry. It defines data integrity as the extent to which all data is complete, consistent and accurate throughout its lifecycle. Regulatory agencies like the FDA and MHRA require data integrity to ensure patient safety. Lack of data integrity can result in warning letters or consent decrees from regulators. The document outlines principles like ALCOA+ to ensure data integrity. It discusses examples of data integrity issues found in warning letters and gives recommendations for proper implementation of data integrity controls and quality culture.
Data integrity Presentation@GCC Regulatory Summit April-2017Cepal & Co.
Rashid Mureed gave a presentation on regulatory challenges with data integrity and data management. He discussed global standards and guidance from organizations like WHO, EMA, MHRA, and FDA. Common deficiencies seen include a lack of audit trails, improper user access controls, and inaccurate or fabricated test results. Mureed emphasized the importance of the ALCOA principles for data integrity and explained that most issues stem from technical failures and bad practices rather than willful misconduct. He provided recommendations for developing a data integrity action plan through risk assessment, defined procedures, training, and fostering a culture of quality.
Data integrity is crucial in the pharmaceutical industry to ensure patient safety and product quality. It refers to data being complete, consistent, and accurate throughout its lifecycle, from generation to storage. Issues can arise from falsification, poor documentation practices, lack of system controls, and not reviewing for errors. To minimize risks, companies should follow good documentation practices like ALCOA+, implement audit trails and quality management systems, and conduct training and system validation. Maintaining data integrity builds trust between regulators and industry.
This document discusses data integrity and good documentation practices. It begins with an introduction to the ALCOA principles for data quality, which stand for Attributable, Legible, Contemporaneous, Original, and Accurate. It then defines data integrity and lists some common data integrity issues seen by regulators. The rest of the document outlines good documentation practices, including the importance of conforming to standards, maintaining document versions and revisions, and avoiding issues like undocumented changes. It emphasizes that poor documentation can undermine drug safety and efficacy and break regulatory trust.
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
- The document discusses data integrity, which refers to maintaining accurate and consistent data over its entire lifecycle. This is important for the regulated healthcare industry as quality decisions are based on data.
- The FDA uses the ALCOA criteria (Attributable, Legible, Contemporaneous, Original, Accurate) to define expectations for electronic data. Regulatory agencies now focus heavily on data integrity due to instances of fabricated documents and errors.
- Common data integrity issues found by agencies include non-contemporaneous recording, backdating records, re-running samples until desired results are obtained, and data fabrication. Ensuring data integrity helps prevent regulatory actions like warning letters or import bans against companies.
The document discusses FDA's expectations around data integrity and compliance with Good Manufacturing Practices (GMP). It provides clarification on key terms like data integrity, metadata, and audit trails. It also addresses FDA's expectations that firms implement strategies to manage data integrity risks in a flexible, risk-based manner. The document indicates that while electronic records and signatures are allowed, all CGMP data must be evaluated and maintained according to regulations. It concludes by answering questions to further clarify terminology.
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
The document discusses the trend toward automating phase I clinical trials. Historically, phase I trials have been largely paper-based, which has led to challenges around volunteer recruitment, complex workflows, scheduling studies, ensuring sample integrity, and accurately capturing data. However, there is a growing trend toward automating phase I trials using solutions like Oracle's LabPas in order to address these challenges, improve efficiency, and help phase I clinics and sponsors better manage costs, quality, and speed of data delivery. The document outlines key benefits and features of LabPas for automating phase I trials.
Implementing ICD-10 In Five Simple StepsHarold Gibson
M-Scribe outlines a 5-step plan for healthcare practices to implement ICD-10: 1) Planning and assessment, 2) Training, 3) Process changes, 4) Transition management, and 5) Testing. The first step involves mapping workflows, identifying gaps, and developing an implementation plan. Step 2 focuses on training staff on ICD-10 codes and documentation changes. Step 3 is updating processes like forms and policies. Step 4 is dual coding during transition and monitoring progress. The final step is testing internally and with external partners like payers. M-Scribe offers practices consultation and recommendations to help with their ICD-10 implementation.
Overview of Computerized Systems Compliance Using the GAMP® 5 GuideProPharma Group
This document provides an overview of the GAMP 5 guide for computerized systems compliance. GAMP 5 aims to build upon existing good practices to help ensure computerized systems are fit for intended use and meet regulatory requirements. It provides a pragmatic, risk-based approach and guidance on key lifecycle activities like planning, specification, verification and change management. Quality risk management is emphasized, including identifying risks, assessing their severity and probability, and controlling high risks. The guidance is flexible and can be applied based on a system's complexity, risks and other factors.
2016-06-08 FDA Inspection Readiness - Mikael Ydemikaelyde
The document discusses preparing for FDA inspections of computer systems and IT infrastructure. It outlines developing an IT compliance plan to ensure control of data, applications, infrastructure, procedures, suppliers, documented evidence, and personnel. The plan should identify any gaps and risks. Organizations should qualify IT systems, validate computerized systems, ensure data integrity, and monitor outsourced processes. Training personnel and periodically reviewing the quality management system are also important for inspection readiness. The speaker emphasizes developing evidence of implementing regulatory requirements to demonstrate control to inspectors.
Chapter 10 of ICT Project Management based on IOE Engineering syllabus. This chapter includes topic related to quality theories, quality planning, cost of quality and more on quality management of project. Provided by Project Management Sir of KU.
Analytical Target Profile (ATP) - Structure and Application Throughout the An...pi
ICH Q2: Validation of Analytical Procedures describes the current concepts of validation, verification and transfer of procedures. This approach addresses portions of the analytical lifecycle but also has a number of downsides. As an alternative to this approach, predefined criteria can be established in the form of an Analytical Target Profile (ATP).
This document discusses using Lean Six Sigma to analyze and optimize workflows in Laboratory Information Management Systems (LIMS). It provides an overview of LIMS and examples of sequential and state machine workflows. The goals of applying a Lean Six Sigma framework to LIMS workflow analysis are to improve complex workflows, learn relevant tools, and ensure consistent, accurate results. Case studies examine assessing a microbiology system and redesigning LIMS workflows. Future developments may include greater mobile integration and external monitoring of LIMS data.
The document discusses project quality management. It provides an overview of quality concepts, quality planning techniques, and the three processes involved in quality management: plan quality management, manage quality, and control quality. Key points include defining quality and quality levels, using tools like cost-benefit analysis and control charts for quality planning, and techniques like audits, problem solving and process analysis that are used to manage and control quality during project execution.
The 5 core tools are recognized as standard quality tools for the automotive ...arvindsinghrathore6
The 5 core tools are recognized as standard quality tools for the automotive industry by AIAG, although they are also used in other manufacturing sectors such as aerospace, defense, medical, and pharmaceutical.
The document discusses the FDA's Quality Metrics program, which aims to use quality metrics data submitted voluntarily by manufacturers to enhance regulatory oversight. It provides an overview of the program's objectives, outlines its evolution from an initial to revised draft guidance, and discusses benefits of participation and the FDA's goals for the short and long term development of the program. The overall vision is for a more efficient and flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs requiring minimal regulatory oversight.
Today Operations Management is dominated by concerns in supply chain such as design of a good performance measurement system, revenue or resource sharing, customer centric and/or process view of the supply chain.
This Presentation is about why CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.
Topics covered:
1.Importance of CRO/Vendor oversight in clinical trial management.
2. Identify the ways to integrate a risk-based approaches to CRO/Vendor oversight.
3. Developing a CRO/Vendor oversight plan with appropriate KPIs/metrics to be measured.
4. Use of tools and technology for accurate and timely reporting.
Mary Lewis presented "Medical Device Development Lifecycle: Demonstrating Clinical Utility" at the Regulatory & Quality Solutions’ Medical Device Breakfast Briefing held at JumpStart, September 11, 2014.
This document discusses data governance and integrity in the pharmaceutical industry. It begins with an overview of data integrity, including definitions of data and how to assure data integrity across the data lifecycle. It then discusses data governance, including how to develop a data governance plan. The plan should consider prevention of data integrity issues and detection of any issues. It should include relevant policies, training, and controls. Finally, it provides tips for implementing a data governance plan in phases with oversight and metrics to track progress.
The document discusses benchmarking and function points as metrics for software projects. It defines benchmarking as comparing business processes and performance metrics to industry best practices. It outlines the benchmarking process which includes identifying what to benchmark, creating a team, collecting data from other organizations, analyzing gaps, and implementing an action plan. The document also discusses function points as a standardized software metric that measures functionality rather than lines of code. It notes the strengths and weaknesses of using function points for economic and quality analyses in software projects.
Quality Assurance in Modern Software DevelopmentZahra Sadeghi
This document discusses quality assurance in modern software development. It begins by providing resources on the topic and outlining the agenda. It then reviews basic concepts of software, quality, and the differences between quality assurance and quality control. It introduces several quality models including McCall's quality model and discusses important factors in software quality. Finally, it covers quality assurance methodology using PDCA, quality management tools including Ishikawa diagrams and Pareto charts, and software quality testing. The document provides a comprehensive overview of key aspects of quality assurance in software development.
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.
Similar to Data integrity - the review process (20)
General Data Protection Regulation (GDPR) - Cross-Border Data Transferspi
The General Data Protection Regulation will Impact all health data processing companies because of the growing importance of customer and patient data to the manufacturer’s business. All companies have to be compliant by 25th May 2018.
This presentation gives an overview of all the possibilities included in the GDPR to allow Cross-Border Data Transfers to third countries.
Software as a Medical Device (SaMD) - IMDRF Definition and Categorisationpi
Following the growing importance of technology in healthcare, Medical Devices have begun to play an increasingly important role in the further development of the life sciences landscape.
One of its more remarkable and fastest growing segments goes under the name Software as a Medical Device. This presentation zooms in on the definition and categorisation, as used by the International Medical Device Regulators Forum.
General Data Protection Regulation - The Belgian Guidance on Records of Proce...pi
End of July 2017, the Belgian Data Protection Authority published guidance on Article 30 of the GDPR.
Under the GDPR, organisations will have to maintain up-to-date and detailed records of all data processing activities. Organisations will have to be compliant with all record keeping requirements, with equal responsibility for data processor and data controllers.
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.
The Quality Metrics Program is an FDA initiative aiming to collect data on certain manufacturing processes from biopharmaceutical companies through an electronic portal. In this presentation, we focus on the practicalities of the program.
ICH Q3D - Elemental impurities in pharmaceutical productspi
The ICH has developed the Q3D guideline on elemental impurities. Both the FDA and the EMA encourage the ICH Q3D guideline implementation. All companies will have to be compliant for already authorised and marketed products as of December 2017.
The document discusses the FDA's Quality Metrics Program, which aims to collect manufacturing process data from biopharmaceutical companies through an electronic portal. The goals are to further develop risk-based inspection models, help predict potential drug shortages, and encourage optimized quality management systems. It provides details on the program's timeline, draft guidance updates, potential benefits to the FDA and industry, and challenges cited by the industry, including harmonization difficulties and increased administrative workload.
Pharmacovigilance and product quality assessmentpi
This document discusses the roles of pharmacovigilance in detecting potential quality issues with pharmaceutical products. It defines key terms like adverse events and quality defects. The document also outlines the history of quality issues, including the 1955 Cutter incident. It describes how quality defects are classified and the process of quality complaint management. Finally, it discusses how pharmacovigilance can be used to detect safety signals that may indicate an underlying quality problem.
This document discusses pharmacovigilance, which involves monitoring the safety of medical products. It defines pharmacovigilance and outlines its history, purpose, and key processes. These include collecting adverse event reports, detecting safety signals, evaluating risks, and implementing risk minimization measures. The document also discusses challenges such as distinguishing true safety signals from background noise and standardizing signal evaluations.
pi is a strategic life sciences consultancy that offers unique expertise to leading life science companies. It dedicates itself to excellence and has grown by focusing on recruiting the best consultants. pi's mission is to bring excellence to the life sciences industry through challenging orthodox thinking and sharing its consultants' knowledge.
Webinar: "The future of European Medical Device Regulations"pi
www.3-14.com
Presentation from our webinar on the 1st June 2016, concerning the future of the European Medical Device Regulations.
Following topics were discussed:
- Proposed MDR scope and definitions
- Economic operators and Person Responsible for regulatory compliance
- Classification and conformity assessment
- Notified Bodies
- Clinical evaluation/investigation
- Technical Documentation – NEW requirements
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdfVedanta A
Air Ambulance Services In Rewa works in close coordination with ground-based emergency services, including local Emergency Medical Services, fire departments, and law enforcement agencies.
More@: https://tinyurl.com/2shrryhx
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NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTblessyjannu21
Prepared by Prof. BLESSY THOMAS, VICE PRINCIPAL, FNCON, SPN.
Emphysema is a disease condition of respiratory system.
Emphysema is an abnormal permanent enlargement of the air spaces distal to terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis.
Emphysema of lung is defined as hyper inflation of the lung ais spaces due to obstruction of non respiratory bronchioles as due to loss of elasticity of alveoli.
It is a type of chronic obstructive
pulmonary disease.
It is a progressive disease of lungs.
English Drug and Alcohol Commissioners June 2024.pptxMatSouthwell1
Presentation made by Mat Southwell to the Harm Reduction Working Group of the English Drug and Alcohol Commissioners. Discuss stimulants, OAMT, NSP coverage and community-led approach to DCRs. Focussing on active drug user perspectives and interests
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
Fit to Fly PCR Covid Testing at our Clinic Near YouNX Healthcare
A Fit-to-Fly PCR Test is a crucial service for travelers needing to meet the entry requirements of various countries or airlines. This test involves a polymerase chain reaction (PCR) test for COVID-19, which is considered the gold standard for detecting active infections. At our travel clinic in Leeds, we offer fast and reliable Fit to Fly PCR testing, providing you with an official certificate verifying your negative COVID-19 status. Our process is designed for convenience and accuracy, with quick turnaround times to ensure you receive your results and certificate in time for your departure. Trust our professional and experienced medical team to help you travel safely and compliantly, giving you peace of mind for your journey.www.nxhealthcare.co.uk
Solution manual for managerial accounting 18th edition by ray garrison eric n...rightmanforbloodline
Solution manual for managerial accounting 18th edition by ray garrison eric noreen and peter brewer_compressed
Solution manual for managerial accounting 18th edition by ray garrison eric noreen and peter brewer_compressed
nursing management of patient with Empyema pptblessyjannu21
prepared by Prof. BLESSY THOMAS, SPN
Empyema is a disease of respiratory system It is defines as the accumulation of thick, purulent fluid within the pleural space, often with fibrin development.
Empyema is also called pyothorax or purulent pleuritis.
It’s a condition in which pus gathers in the area between the lungs and the inner surface of the chest wall. This area is known as the pleural space.
Pus is a fluid that’s filled with immune cells, dead cells, and bacteria.
Pus in the pleural space can’t be coughed out. Instead, it needs to be drained by a needle or surgery.
Empyema usually develops after pneumonia, which is an infection of the lung tissue. it is mainly caused due in infectious micro-organisms. It can be treated with medications and other measures.
This particular slides consist of- what is hypotension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
Hypertension and it's role of physiotherapy in it.Vishal kr Thakur
This particular slides consist of- what is hypertension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is summary of hypertension -
Hypertension, also known as high blood pressure, is a serious medical condition that occurs when blood pressure in the body's arteries is consistently too high. Blood pressure is the force of blood pushing against the walls of blood vessels as the heart pumps it. Hypertension can increase the risk of heart disease, brain disease, kidney disease, and premature death.
Mental Health and well-being Presentation. Exploring innovative approaches and strategies for enhancing mental well-being. Discover cutting-edge research, effective strategies, and practical methods for fostering mental well-being.
India Home Healthcare Market: Driving Forces and Disruptive Trends [2029]Kumar Satyam
According to the TechSci Research report titled "India Home Healthcare Market - By Region, Competition, Forecast and Opportunities, 2029," the India home healthcare market is anticipated to grow at an impressive rate during the forecast period. This growth can be attributed to several factors, including the rising demand for managing health issues such as chronic diseases, post-operative care, elderly care, palliative care, and mental health. The growing preference for personalized healthcare among people is also a significant driver. Additionally, rapid advancements in science and technology, increasing healthcare costs, changes in food laws affecting label and product claims, a burgeoning aging population, and a rising interest in attaining wellness through diet are expected to escalate the growth of the India home healthcare market in the coming years.
Browse over XX market data Figures spread through 70 Pages and an in-depth TOC on "India Home Healthcare Market”
https://www.techsciresearch.com/report/india-home-healthcare-market/15508.html
The Importance of Black Women Understanding the Chemicals in Their Personal C...bkling
Certain chemicals, such as phthalates and parabens, can disrupt the body's hormones and have significant effects on health. According to data, hormone-related health issues such as uterine fibroids, infertility, early puberty and more aggressive forms of breast and endometrial cancers disproportionately affect Black women. Our guest speaker, Jasmine A. McDonald, PhD, an Assistant Professor in the Department of Epidemiology at Columbia University in New York City, discusses the scientific reasons why Black women should pay attention to specific chemicals in their personal care products, like hair care, and ways to minimize their exposure.
Test bank clinical nursing skills a concept based approach 4e pearson educati...rightmanforbloodline
Test bank clinical nursing skills a concept based approach 4e pearson education
Test bank clinical nursing skills a concept based approach 4e pearson education
Test bank clinical nursing skills a concept based approach 4e pearson education