Peter Zipfell, product marketing manager at Thermo Fisher Scientific explains how better software can help pharmaceutical manufacturers keep their data accurate.
Data
Every day in pharmaceutical manufacturing, countless decisions are made which have the potential to directly impact public health. At the core of these decisions lies the constant monitoring of carefully selected parameters with known or potential consequences on product safety or efficacy. The degree to which data is complete, consistent, and accurate across its entire lifecycle is referred to as ‘data integrity’ and is monitored by regulatory agencies. While adherence to data integrity guidelines indicate good practices, incomplete or inaccurate records can reflect poor data management systems, human error, or intentional data falsification.
As failure to ensure data integrity contributes to compromised product quality, pharmaceutical manufacturers are required to keep an audit trail; a secure electronic system that maintains an accurate record of events to enable a historical reconstruction of the data. However, audit trails are challenging; maintaining a meticulous record of complex processes across multiple sources can be difficult for manufacturers, while audit trail assessments represent an onerous and multifaceted task for reviewers.