Going Digital In A GLP Environment

For a typical GMP (Good Manufacturing Practice) based company, the data supports the product; but in a GLP (Good Laboratory Practice)-regulated study, the data is the product. This gives some GLP compliance professionals a little anxiety over making the move. In addition, the GLP regulations are fairly silent on using digital strategies and, therefore, can be wrongly interpreted as not allowing them.

However, this is not true.

Implementing Digital Technologies in GLP-Regulated Company

For a GLP-regulated company, going digital means adopting and implementing digital technologies and solutions in their operations and processes. This transition to digital systems and tools can have different implications for a GLP-regulated company.

Before jumping in and digitalizing everything, here are a few key points to consider:

Electronic Data Management

Going digital involves digitalizing and managing laboratory data and records electronically. This includes electronic data capture, storage, and retrieval of study-related information, such as raw data, study protocols, standard operating procedures (SOPs), and quality control documentation. It typically replaces traditional paper-based systems, enabling more efficient data management and reducing the risk of errors or loss of information.

Laboratory Information Management Systems (LIMS)

GLP-regulated companies can implement LIMS to streamline their laboratory workflows, data tracking, and sample…