Orlando  Lopez Author of Evaluating Organization Development

Orlando Lopez

Data Integrity SME

Orlando has worldwide pharmaceutical experience with relevant work in computer systems regulatory requirements including US, EMA, Australian, Japanese, WHO, PIC/S, and ICH regulations and computer-related guidance's. Experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications.


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 Featured Title - Ensuring the Integrity of Electronic Health Records:Lopez - 1st Edition book cover


ECA GMP Journal

E-records Vulnerabilities

Published: Mar 10, 2021 by ECA GMP Journal
Authors: Orlando Lopez

Using a DaaS environment as an example, the objective of this article is to briefly discuss the areas to look at during the assessment of the e-records integrity vulnerabilities.

Journal of Validation Technology

Introduction to Data Quality

Published: Apr 27, 2020 by Journal of Validation Technology
Authors: Orlando Lopez

This paper discusses the significance of data quality and how it must provide accurate, valid, consistent, reliable, and complete records in order to support quality medicines

IVT Network

CGMP E-Records Risk Assessments

Published: Sep 25, 2019 by IVT Network
Authors: Orlando Lopez
Subjects: Pharmaceutical Science & Regulation

Based on NIST SP 800-33, Computer Security, and the EMA Q&A GMP Data Integrity (AUgust 2016), this paper covers the basic technical elements to assess the risk to the integrity of CGMP e-records throughout the e-records life cycle. However, this is not an all inclusive list.

Pharmaceutical Technology

Removing Gaps in Data Integrity

Published: Jul 11, 2019 by Pharmaceutical Technology
Authors: Agnes Shanley

FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards. Orlando Lopez was interviewed for this article.

Pharmaceutical Technology Europe

Defining and Managing Raw Manufacturing Data

Published: Jun 01, 2019 by Pharmaceutical Technology Europe
Authors: Orlando Lopez
Subjects: Pharmaceutical Science & Regulation

This article discusses the technological and procedural controls and how they should be implemented for identification, storage, protection, retrieval, retention time, and disposition of current good manufacturing practice (cGMP) records.

Pharmaceutical Engineering

Maxims Electronic Records Integrity

Published: May 03, 2019 by Pharmaceutical Engineering
Authors: Orlando Lopez
Subjects: Pharmaceutical Science & Regulation

This article discusses these e-records integrity maxims applicable to the medicines’ manufacturing operations. The lifecycle, the validity and fidelity, and the reliability to the e-records integrity are maxims or fundamental rules in an effective e-records integrity program.

GXP Compliance Journal

Technologies Supporting Electronic Records Integrity (Part II)

Published: Oct 29, 2017 by GXP Compliance Journal
Authors: OrlandoLopez

Part II describes how the combination of these tools, described in Part I, can mitigating threats to and vulnerabilities related to e-records integrity.

Journal Gxp Compliance

Technologies Supporting Electronic Records Integrity (Part I)

Published: May 30, 2017 by Journal Gxp Compliance
Authors: Orlando Lopez

Centred on information security, this article provides a broad overview of the cryptographic technologies that can keep e-records integrity for any GMP regulated activity. Part I of this article describes each individual technology such as: E-records encryption, digital signatures and services family (e.g., Virtual Private Network). These are the set of tools and techniques ensuring the integrity and validity of the information throughout the e-records lifecycle

Journal of Validation Technology

Electronic Records Integrity in the Data Warehouse Environments

Published: Sep 15, 2016 by Journal of Validation Technology
Authors: Orlando Lopez

This article covers the electronic records (e-records) integrity topics associated with data warehouse (DW) and business intelligence (BI) environments. The data integrity related definitions used in this article are based on MHRA recent guidance document. Vol. 22, Issue 2, Apr 2016

Pharmaceutical Engineering

A Computer Data Integrity Compliance Model

Published: Mar 01, 2015 by Pharmaceutical Engineering
Authors: Orlando Lopez

This article proposes a model describing the required Annex 11 data integrity provisions applicable to new computer system implementations. This model can be used as well to assess computer systems in operation.