Maintaining a supply of high-quality product for patients is reliant on the accuracy and completeness of data generated during the development and manufacturing process.
Data integrity is critical to ensure that the electronic and paper records we archive and the information they contain retain evidence of the quality of the work performed. This talk discusses data integrity, what it is, and how to implement a robust data integrity program.
1- Global regulatory focus
Data integrity is the accuracy, reliability, and consistency of data. During an inspection, regulators verify that data integrity is integral to your modern quality management system—the backbone of compliance and quality assurance. How clearly defined is your approach to data integrity?
2- Key elements of a robust data integrity program
Regulatory inspectors focus on evaluating data integrity and performance against defined requirements. A regulatory inspection will determine if the data are accurate, complete, consistent, and ensure data are not changed without sufficient justification. What are the key requirements that drive confidence in your data?
3- Audit trail review expectations
Audit trail review requires the periodic examination of an audit trail. While this can seem overwhelming, there are elements to consider for a manageable and meaningful process. A program that considers system risk, technical controls in the software, and existing data review processes will deliver a robust well-organized approach. How effective and efficient is your audit trail review program?
The data captured in records is the objective evidence of the quality of the work performed and the compliance to requirements. A strong data integrity program is essential to meeting current expectations of global regulatory requirements.
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, biologics organizations; Job function: quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.
Stephanie Gaulding,CQA, CPGP
M.Sc. biotechnology, Johns Hopkins University
B.Sc. biology, Virginia Tech
Vice President, Regulatory Compliance,
M.Sc. bioengineering, Clemson University
B.Sc. engineering science and mechanics, Virginia Tech