Orlando López

Gebundenes Buch

Ensuring the Integrity of Electronic Health Records

The Best Practices for E-records Compliance

Beschreibung

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.

Autor

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.

Produktdetails

• Verlag: Productivity Press
• Seitenzahl: 342
• Erscheinungstermin: 22. Dezember 2020
• Englisch
• Abmessung: 260mm x 183mm x 23mm
• Gewicht: 839g
• ISBN-13: 9780367616052
• ISBN-10: 036761605X
• Artikelnr.: 59991411