E-Records Integrity Requirements


Series: Research Methodology and Data Analysis
BISAC: COM018000; COM051330
DOI: https://doi.org/10.52305/BALY7555

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.

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Table of Contents



Chapter 1. Introduction

Chapter 2. What is Data Integrity?

Chapter 3. E-Records Lifecycle

Chapter 4. Management of Computer System Requirements

Chapter 5. Integration Between Computer Systems and E-Records Lifecycles

Chapter 6. CGMP E-Records Risk Management

Chapter 7. Supporting Services

Chapter 8. Generation, Capture or Recording of Raw Data

Chapter 9. E-Records Maintenance and Use

Chapter 10. E-Records Disposal

Chapter 11. E-Records Transfer

Chapter 12. Metadata

Chapter 13. Reporting

Chapter 14. E-Records Vulnerabilities

Chapter 15. Introduction to Data Quality

Appendix I. Glossary of Terms

Appendix II. Abbreviations and/or Acronyms

Appendix III. References

Appendix IV. E-Records Handling – 21 CFR Part 211

Appendix V. E-Records Handling – EU Annex 11

Appendix VI. Regulatory Analysis

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