Data integrity and compliance : a primer for medical product manufacturers / Jose Rodríguez-Pérez, PhD.

Format:

Book

Author/Creator:

Rodríguez Pérez, José, 1961- author.

Contributor:

American Society for Quality, issuing body.

Language:

English

Physical Description:

1 online resource (278 pages) : illustrations

Place of Publication:

Milwaukee, Wisconsin : ASQ Quality Press, 2019.

Summary:

Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.

Contents:

Data integrity and good documentation practices

ALCOA : expectations and examples

Regulatory expectations

Regulatory enforcement

Data life-cycle

Integrating data integrity into the quality system

Clinical data integrity

Preventing data integrity problems

Data governance and data integrity audit

Good documentation practices and data integrity training

Investigating and disclosing data integrity issues

Data integrity for outsourced activities

Maintaining integrity of electronic data.

Notes:

Description based on print version record.

Includes bibliographical references and index.

ISBN:

9781951058487

1951058488

9781523132331

1523132337

9781951058470

195105847X