Elements of a Code of Conduct for Data Integrity in the Pharmaceutical Industry

Data Integrity has been and currently is a major global concern of Health Authorities and the pharmaceutical industry. Lack of awareness of regulatory requirements, employee errors, failure to check accuracy of data, software or system malfunction, configuration problems with electronic data handling or malfeasance by employees can lead to data integrity issues.

One of the foundational concepts identified by PDA members as important to preventing and uncovering data integrity issues is a common understanding of the expectations for employee and management conduct. As a result, PDA has developed and made available to the industry a collection of recommended best practices related to data integrity in a ready to use format.

The Elements of a Code of Conduct for Data Integrity in the Pharmaceutical Industry outlines key elements necessary to help ensure the reliability and integrity of information and data throughout all aspects of a product's lifecycle. It is intended to be used in whole or in part to guide a company’s internal practices, create or modify an existing data integrity code of conduct, or in developing agreements with outsourcing partners or other suppliers. The elements identified throughout this document are intended to reinforce a culture of quality and trust within the pharmaceutical industry.

If you have questions regarding this document or would like more information about PDA’s activities related to data integrity, please visit https://www.pda.org/dataintegrity.

We have made this information available as a service to the pharmaceutical industry and would ask that, should you duplicate or re-use any of this information, you acknowledge PDA as the originator.

Terms of Use: This document is not intended to be a regulatory standard or guidance, nor is it intended to supersede any country specific or local laws and regulations governing labor, privacy and/or employee rights. The document was developed through the collaboration of PDA members with experience in manufacturing operations, quality, auditing, compliance and consulting and has been peer reviewed by attorneys with extensive food and drug law experience.