Ensuring the Regulatory Compliance of Laboratory Data
Laboratory staff in regulated environments must be able to provide documented evidence of all activities, cross-checked by a second person and readily available for auditors to ensure compliance with national and industry regulations. Simply storing the results of an analysis is insufficient – all of the raw data, relevant process information and metadata must also be provided.
Standard operating procedures (SOPs) are an essential tool for any regulated laboratory environment. It provides a detailed explanation of how a specific activity or analysis should be performed and, crucially, how the relevant data and results should be processed and recorded. Many labs working under GLP, GMP or GAMP regulations have adopted LIMS (laboratory information management systems) and ELNs (electronic laboratory notebooks) to help staff collate data from an array of analytical tests. Unfortunately, many of these electronic systems do not capture the metadata – such as instrument service status, user ID and the method used – required for full regulatory compliance.
The Laboratory Data Integrity Guide provides practical advice on reducing errors, simplifying processes and reinforcing compliance to achieve comprehensive data security. It offers various examples of how to design analytical workflows to ensure robust data integrity, and highlights potential risks to this process.