Drug Digest: Unpacking the Science Behind Data Integrity

In a highly regulated industry such as pharmaceuticals each company needs to prove the quality of their products by showing data produced during their production processes. Management of records and data by these regulated companies is controlled by data governance, which embraces people, processes, and the technology required for effective data handling. All this leads directly into the production of high-quality drug product.

Keeping up with requirements is obviously a vital step, but more generally, prioritizing how to actively demonstrate what controls you have in place to prove trust in the data in your organization, every data lifecycle step, the GxP (IT and non-IT) systems, and all related processes, makes a vital difference in how regulators see your quality management maturity (QMM) but also how both staff and clients see the company itself.

In this episode of Drug Digest, Grant Playter, associate editor, speaks with computer validation experts on how to set data controls and why efforts spent here are financially rewarding in the long run.

Interview featuring:

Paige Kane is a member of the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin. Paige brings over 30 years’ experience working in a regulated environments (including Pfizer, Wyeth, Genetics Institute, Monsanto and USDA/USCS), and has been responsible for developing and implementing KM programs, quality systems for GLP, GCP, and GMP, electronic records/electronic signatures programs, and automation validation methodologies.

Garry Wright is European Laboratory Compliance Specialist at Agilent Technologies. Garry has 25 years of experience working within regulated pharmaceutical environments and providing compliance guidance to regulated companies across Europe.

Sponsors:

This episode of Drug Digest is sponsored by:

• Aizon
• Labvantage
• Thermo Fisher Scientific

About Drug Digest

Drug Digest is a tech talk video series with the Pharmaceutical Technology editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.