Orlando López

Ensuring the Integrity of Electronic Health Records (eBook, PDF)

The Best Practices for E-records Compliance

• Format: PDF

Produktbeschreibung

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.

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 340
• Erscheinungstermin: 21. Dezember 2020
• Englisch
• ISBN-13: 9781000222999
• Artikelnr.: 60400482

Autorenporträt

Orlando Lopez has significant understanding and experience with worldwide regulatory authorities regarding CSV, e-records integrity, and related requirements/guidelines related to Production Manufacturing Systems, IT Systems, Analytics, and Business Intelligence. He has knowledge and experience in the development of governance and SLC deliverables. Wrote and deployed CSV methodology to computer infrastructure J&J worldwide. Several times he had re-engineered the computer validation methodology to regulated companies. Orlando Lopez has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications. He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation and has written 25+ publications, including 9 computer compliance related books - amazon.com/author/orlandolopez/ Familiar with gap assessment, remediation planning and remediation execution activities.

Inhaltsangabe

1 Introduction 2 E
records Lifecycle Revisited 3 Data and E
records Lifecycles
A Comparison 4 MHRA Guidance
Revisited 5 E
records Integrity Expectations of EU GMP Inspectors 6 Comparison of Health Authorities E
records Integrity Expectations 7 Maxims of E
records Integrity 8 Vulnerabilities of E
records 9 CGMP E
records Risk Management 10 CGMP E
records Risk Assessments 11 Security Service 12 Defining and Managing Manufacturing Data 13 Controls on Transient Data 14 Digital Date and Timestamps 15 E
records Migration and Its Integrity 16 Ensuring E
records Integrity of Cloud Service Providers 17 E
records Integrity in Hybrid Systems 18 Technologies Supporting E
records Integrity 19 Integration Between Computer Systems and E
records Lifecycles 20 Miscellaneous E
records Integrity Issues 21 E
records Remediation Project Revisited
Medicine Manufacturing 22 Designing E
records Integrity into your Practices 23 Introduction to Data Quality 24 Summary