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.
In 2017, data integrity issues were cited in 65 % of all FDA warning letters, chiefly due to incomplete data. Failing to work in a regulatory compliant manner carries huge risks, including import bans, product recalls and even closure of production plants.
For laboratories that must comply with GLP, GMP and GAMP regulations it is important to maintain records or documented evidence of all relevant analyses, which can be checked by a second person and made available for auditing. Storing results is not enough: each dataset must be complete and contain all relevant metadata.
Standard operating procedures (SOPs) are an essential tool for any regulated laboratory, providing 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 have adopted laboratory information management systems (LIMS) and electronic laboratory notebooks (ELNs) to help staff collate data from an array of analytical tests. However, not all of these electronic systems capture the metadata – such as instrument service status, user ID and method of analysis – required for full regulatory compliance.
This guide offers practical advice on reducing errors, simplifying processes and reinforcing compliance to achieve comprehensive laboratory data integrity and security. It offers examples of how to design analytical workflows to ensure robust data capture, and highlights potential risks to this process.