Considerations for a Corporate Data Integrity Program
Regulatory agencies, as well as industry, rely on accurate information to ensure drug quality and patient safety. If the information associated with a drug product is not accurate, complete, or reliable, a company cannot ensure the safety and efficacy of their product for the patient. Data Integrity therefore has become one of the hottest regulatory and compliance topics impacting the pharmaceutical industry in years. Non-compliance has resulted in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, Application Integrity Policy Invocations/ legal action, and most concerning, patient harm. It is as much a compliance issue as it is a financial issue, as seen by the impact these regulatory actions have on company’s stock price and bottom line. For these reasons, pharmaceutical companies are being driven to implement or review their corporate data integrity compliance programs to meet these expectations.
To help understand the critical success factors for a corporate data integrity program, the ISPE GAMP® COP released a Concept Paper entitled “Considerations for a Corporate Data Integrity Program”. The paper addresses the topics of executive sponsorship, cross functional ownership, risk-based prioritization, planning for continuous improvement, and focusing on the data integrity lifecycle. It also provides some practical insights into ensuring the sustainability of the program and the data integrity lifecycle.
As the GAMP® Global Chair and the sponsor of the Data Integrity Special Interest Group (SIG), I encourage you to read the Considerations for a Corporate Data Integrity Program concept paper. It is the first of many information sources about Data Integrity being delivered by SIG and ISPE on this subject and has served as the basis for several recent ISPE conference presentations. I also encourage you to continue to visit the ISPE website for more information and respond to this blog post on the data integrity program so SIG can continue to address your needs in future deliverables. Consider joining SIG if you’re interested in learning more about data integrity and/or contributing to this effort. To get involved, please contact one of the SIG Chairs listed in the concept paper or reply to this blog and we will follow up with you.
Consultant – Laboratory and Quality Systems
Medicines Development Unit (MDU) – Business Systems Support
Eli Lilly and Company
Are you looking for a hands-on approach for identifying, mitigating, and remediating potential causes of breaches in data integrity?
Don’t miss this special half-day Data Integrity Workshop focused on key data integrity issues facing the pharmaceutical product lifecycle. This interactive workshop will identify important regulatory issues impacting data integrity, answer key questions surrounding current expectations, and provide an overview of the Application Integrity Policy. Learn more about the Data Integrity Workshop and how to register.