Data Integrity In Pharmaceutical And Medical Devices Regulation Operations PDF Download
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Author | : Orlando Lopez |
Publisher | : CRC Press |
Total Pages | : 268 |
Release | : 2016-11-03 |
Genre | : Business & Economics |
ISBN | : 1315349973 |
Download Data Integrity in Pharmaceutical and Medical Devices Regulation Operations Book in PDF, ePub and Kindle
Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.
Author | : José Rodríguez-Pérez |
Publisher | : Quality Press |
Total Pages | : 143 |
Release | : 2019-05-08 |
Genre | : Business & Economics |
ISBN | : 0873899873 |
Download Data Integrity and Compliance Book in PDF, ePub and Kindle
Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectationits a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sourcesincluding the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agencyinto a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.
Author | : Orlando Lopez |
Publisher | : Taylor & Francis |
Total Pages | : 326 |
Release | : 2018-10-02 |
Genre | : Business & Economics |
ISBN | : 1351704346 |
Download Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation Book in PDF, ePub and Kindle
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
Author | : R D McDowall |
Publisher | : Royal Society of Chemistry |
Total Pages | : 660 |
Release | : 2018-11-06 |
Genre | : Science |
ISBN | : 1788016629 |
Download Data Integrity and Data Governance Book in PDF, ePub and Kindle
Data integrity is the hottest topic in the pharmaceutical industry. Global regulatory agencies have issued guidance, after guidance after guidance in the past few years, most of which does not offer practical advice on how to implement policies, procedures and processes to ensure integrity. These guidances state what but not how. Additionally, key stages of analysis that impact data integrity are omitted entirely. The aim of this book is to provide practical and detailed help on how to implement data integrity and data governance for regulated analytical laboratories working in or for the pharmaceutical industry. It provides clarification of the regulatory issues and trends, and gives practical methods for meeting regulatory requirements and guidance. Using a data integrity model as a basis, the principles of data integrity and data governance are expanded into practical steps for regulated laboratories to implement. The author uses case study examples to illustrate his points and provides instructions for applying the principles of data integrity and data governance to individual laboratory needs. This book is a useful reference for analytical chemists and scientists, management and senior management working in regulated laboratories requiring either an understanding about data integrity or help in implementing practical solutions. Consultants will also benefit from the practical guidance provided.
Author | : Sarah Tanksley |
Publisher | : CRC Press |
Total Pages | : |
Release | : 2017-09-30 |
Genre | : |
ISBN | : 9781138731936 |
Download Data Integrity in the Pharmaceutical Industry Book in PDF, ePub and Kindle
Many articles describe the history and theory behind data integrity. However, few offer practical advice and solutions. Written by an author with a vast amount of experience in the industry, Data Integrity in the Pharmaceutical Industry: Current Topics and Effective Strategies serves as a hands-on guide to the current regulatory expectations for generating and handling data. This unique text presents techniques for tracing the life cycle of data, as well as identification and avoidance of common blind spots in the data collection and review process, examples of lapses in data integrity, and strategies for remediation of data integrity breaches. It also discusses requirements and advice for communicating data integrity breaches to health authorities. As international government bodies have shifted their point of interest to focus on data integrity as part of their routine operations, this book is a must read for anyone working in a GMP (good manufacturing practices) regulated environment, whether the job involves supporting, generating, reviewing, or archiving data.
Author | : Orlando López |
Publisher | : CRC Press |
Total Pages | : 203 |
Release | : 2020-12-21 |
Genre | : Business & Economics |
ISBN | : 1000223035 |
Download Ensuring the Integrity of Electronic Health Records Book in PDF, ePub and Kindle
Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.
Author | : Orlando López |
Publisher | : CRC Press |
Total Pages | : 287 |
Release | : 2004-01-15 |
Genre | : Medical |
ISBN | : 1135488754 |
Download 21 CFR Part 11 Book in PDF, ePub and Kindle
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places
Author | : Agency for Healthcare Research and Quality/AHRQ |
Publisher | : Government Printing Office |
Total Pages | : 396 |
Release | : 2014-04-01 |
Genre | : Medical |
ISBN | : 1587634333 |
Download Registries for Evaluating Patient Outcomes Book in PDF, ePub and Kindle
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author | : World Health Organization |
Publisher | : World Health Organization |
Total Pages | : 147 |
Release | : 2010 |
Genre | : Medical |
ISBN | : 9241564040 |
Download Medical Devices Book in PDF, ePub and Kindle
Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Author | : Barbara Killinger |
Publisher | : McGill-Queen's Press - MQUP |
Total Pages | : 221 |
Release | : 2010 |
Genre | : Philosophy |
ISBN | : 0773582800 |
Download Integrity Book in PDF, ePub and Kindle
How to restore integrity so that social values can be upheld and family welfare strengthened.