E-records integrity requirements
著者
書誌事項
E-records integrity requirements
（Research methodology and data analysis）
Nova Science Publishers, c2022
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
The worldwide medicines' manufacturing practices regulations depend heavily on reliable data and records. The information properly recorded is the basis for manufacturers to assure the regulatory authorities of product identity, strengths, purity, and safety. The collected electronic records (e-records) also demonstrate that the manufacturing process adheres to the CGMP, including instructions. An element of reliable records is the integrity of such records. For the relevant stakeholders, such unauthorized alterations will be catalogued that the system is without the proper data integrity (DI) controls and would be deemed a noticeable deficiency. As a state or condition, e-records integrity is a measure of the validity and fidelity of related data. Based on the Universal Electronic Records Management (ERM) Requirements, Version 2.03 published by the National Archives and Records Administration (NARA), this book covers the requirements applicable to DI in the medicines' manufacturing practices regulations, pharmaceutical and biotechnological. This book presents the bounded characterization of e-records handling systems. The reader will have a reference of over fifty-three requirements that need to be agreed upon between the relevant stakeholders.
目次
- Foreword
- Preface
- Introduction
- What is Data Integrity?
- E-Records Lifecycle
- Management of Computer System Requirements
- Integration Between Computer Systems and E-Records Lifecycles
- CGMP E-Records Risk Management
- Supporting Services
- Generation, Capture or Recording of Raw Data
- E-Records Maintenance and Use
- E-Records Disposal
- E-Records Transfer
- Metadata
- Reporting
- E-Records Vulnerabilities
- Introduction to Data Quality
- Glossary of Terms
- Abbreviations and/or Acronyms
- References
- E-Records Handling 21 CFR Part 211
- E-Records Handling EU Annex 11
- Regulatory Analysis.
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