Data Integrity in Pharmaceutical and Medical Devices Regulation Operations ─ Best Practices Guide to Electronic Records Compliance

Lopez describes good electronic records integrity practices relevant to the Worldwide Health Agency Good Manufacturing Practices. Based on risk assessment principles, he provides practical information to enable compliance with electronic records integrity while highlighting and integrating worldwide regulation into the subject. Among his topics are electronic records life cycle, electronic records related definitions, relevant worldwide good manufacturing practices regulations and guidelines, trustworthy computer systems, procedural controls for handling electronic records, electronic record controls: supporting processes, electronic record controls while in transit, electronic records and contract manufacturers, and self-inspections. Annotation ©2017 Ringgold, Inc., Portland, OR (protoview.com)

Orlando Lopez has worked in the areas of worldwide pharmaceutical validation, Part 11 remediation, and EMA Annex 11 in the production and quality control systems relevant to the manufacture of medicinal products for the past twenty five years. He is a SME on electronic records integrity and worldwide regulations applicable to computer compliance. He had papers published in the ISPE's Pharmaceutical Engineering, Pharmaceutical Technology and GXP Journal magazines.

Experience:

• Validation/qualification of data warehouses (DW) and business intelligence (BI) environments.
• Writing service level agreements in DW/BI environments.
• Computer systems validation and computer infrastructure qualification; retrospective evaluation.
• Erecs integrity controls.
• Direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications.
• Integration of two IT departments SLC and CSV methodologies.

He is the author of three books: 21 CFR Part 11 - A Complete Guide to International Compliancepublished by Sue Horwood Publishing Limited, Computer Infrastructure Qualifications for FDA Regulatory Industriespublished by Davis Healthcare International Publishing, and EU Annex 11 Guide to Computer Validation Compliance for Worldwide Health Agency GMP,published by CRC Press in 2015.