Download or read book Good Computer Validation Practices written by Teri Stokes and published by CRC Press. This book was released on 1994-05-31 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: This sensible text on computer systems validation examines the regulatory and practical issues of computer validation from a global perspective and provides a common-sense approach to getting the job done. Combining the insights of an internationally respected group of computer systems specialists, healthcare industry professionals, and a regulator, it provides SOPs, checklists, and tips to make global computer validation an obtainable goal. Topics and concerns detailed in the text span the breadth of issues and influences imposed upon computer validation by worldwide GCP, GLP, and GMP requirements and provide an approach that meets the regulatory and real-world needs of the healthcare manufacturing and research industries.
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
Download or read book The Survive and Thrive Guide to Computer Validation written by Teri Stokes and published by CRC Press. This book was released on 1998-05-31 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Computer validation regulations have increased worldwide by 300 percent since 1991. Drawing on her practical project experience in pharmaceutical, biotech, and software companies around the world, author Terri Stokes provides you with the tools they need to develop validation practices that fit into their organization's culture and can be integrated into the normal workflow of regulated activities. She clearly explains the influences placed upon computer validation by the worldwide GLP and GMP regulations and then helps to integrate good validation techniques into the laboratory or manufacturing environment.
Download or read book Pharmaceutical Computer Validation Introduction written by Daniel Farb and published by Universityofhealthcare. This book was released on 2003-12-01 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, and so on.
Download or read book Validating Pharmaceutical Systems written by John Andrews and published by CRC Press. This book was released on 2019-08-30 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners on how to fulfill them. John Andrews and his team tackle the perceived complexities surrounding the validation of a wide variety of automated systems. Sprinkled with case studies and real-life examples, the book offers a step-by-step review of topics such as planning, design, auditing, risk management, and specification. The in-depth, by example coverage demystifies the challenges of manufacturing execution systems(MES), laboratory information management systems(LIMS), and network qualification. The first section examines the different levels of automated systems used throughout the drug development, manufacture, and delivery lifecycle, using the GAMP 4 lifecycle approach to their validation. The second section uncovers some real-life applications of GAMP 4 to different areas of the regulations such as GLP, GCP, GMP, and GDP. The book explores some of the latest thinking on computer validation and reflects changes that have occurred in the industry since the early days of validation. The contributors are a deliberate blend of those who have faced the problems of the 1990s and the Y2K controversies and those who have more recently arrived on the scene and made an impact on the perception of validation of automated systems across the field of GxP. They do more than show you how to do the right thing; they show you how to do the right thing in compliance with regulations.
Download or read book Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry written by Stephen Robert Goldman and published by 1st Book Library. This book was released on 2003 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib
Download or read book Validation of Computerized Analytical Systems written by Ludwig Huber and published by CRC Press. This book was released on 2023-04-28 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details. International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
Download or read book 21 CFR Part 11 written by Orlando López and published by CRC Press. This book was released on 2004-01-15 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP written by Orlando Lopez and published by CRC Press. This book was released on 2015-04-06 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is
Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Download or read book Standards and Practices for Computer Validation and System Definition written by AR. Bluhm and published by . This book was released on 1996 with total page 13 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the validation of automated systems for the pharmaceutical and health care industries, assurance of compliance with applicable regulations is accomplished through a well designed validation program. The program must be designed to provide documented evidence that automated systems (hardware and software) have done, are doing, and/or will do, reliably, what they are supposed to do--the key word in this statement being "documented." The documentation requirements for automated, particularly "paperless" systems, can be a formidable obstacle to validation; however, if a modular, or life-cycle, approach (qualification of the component parts followed by qualification of the integrated system) is used the task becomes manageable. One approach we have found in our experience to successfully generate, evaluate, and manage the documentation required for validation of automated systems is the use of a Quality Plan. This approach has also proved invaluable in defining the system, the first step in any life-cycle approach to validation of an automated system. The following discussion outlines the Quality Plan approach to validation of computer systems, and focuses on system definition because of its importance as the basis for both the design and testing of these systems and associated software. Although the discussion addresses systems used primarily in the pharmaceutical and health care industries, the Quality Plan concept is applicable to any system that must function reliably and with documented performance.
Download or read book Validating Corporate Computer Systems written by Guy Wingate and published by CRC Press. This book was released on 2000-05-31 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.
Download or read book Validation Compliance Annual written by International Validation Forum and published by CRC Press. This book was released on 1995-02-17 with total page 1114 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."
Download or read book Computer Simulation Validation written by Claus Beisbart and published by Springer. This book was released on 2019-04-09 with total page 1074 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique volume introduces and discusses the methods of validating computer simulations in scientific research. The core concepts, strategies, and techniques of validation are explained by an international team of pre-eminent authorities, drawing on expertise from various fields ranging from engineering and the physical sciences to the social sciences and history. The work also offers new and original philosophical perspectives on the validation of simulations. Topics and features: introduces the fundamental concepts and principles related to the validation of computer simulations, and examines philosophical frameworks for thinking about validation; provides an overview of the various strategies and techniques available for validating simulations, as well as the preparatory steps that have to be taken prior to validation; describes commonly used reference points and mathematical frameworks applicable to simulation validation; reviews the legal prescriptions, and the administrative and procedural activities related to simulation validation; presents examples of best practice that demonstrate how methods of validation are applied in various disciplines and with different types of simulation models; covers important practical challenges faced by simulation scientists when applying validation methods and techniques; offers a selection of general philosophical reflections that explore the significance of validation from a broader perspective. This truly interdisciplinary handbook will appeal to a broad audience, from professional scientists spanning all natural and social sciences, to young scholars new to research with computer simulations. Philosophers of science, and methodologists seeking to increase their understanding of simulation validation, will also find much to benefit from in the text.
Download or read book Validation Practices for Biotechnology Products written by J. K. Shillenn and published by ASTM International. This book was released on 1996 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents the current methods and practices by which companies that produce genetically altered drugs assure that all components and finished products have the identity, strength, quality, and purity that is purported and represented. Also considers possible improvements and whether industry standard
Download or read book Validation Standard Operating Procedures written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2001-12-27 with total page 498 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls, and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to achieve compliance, or the standard operating procedures and documentation required. This text provides the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard Operating Procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States. The CD-ROM contains 74 template validation standard operating procedures that can be tailored to meet the regulatory compliance requirements of any pharmaceutical, diagnostic, medical device, medical equipment, and biotech product. You can edit, print, and customize these procedures to fit your needs. The book and CD work together to minimize the number of documents used and to ensure their accuracy. All critical elements and requirements of validation are covered, so you can easily implement them and avoid the stress that usually accompanies an FDA audit. Features Provides all the information that managers need to establish functions, acceptance criteria, and validation procedures in compliance with FDA guidelines Includes step-by-step directions for translating GMP requirements into action, based on your company's Master Validation Plan and execution protocols Describes how to establish test functions and prevent defects in order to produce products that are fit for use Serves as an ideal companion to Haider's Pharmaceutical Master Validation Plan
Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
