The Good Laboratory Practice (GLP) regulations require the validation of computerized systems used in laboratories to ensure they are suitable for their intended purpose.
These systems include those used for data generation, measurement, calculation, assessment, transfer, processing, storage, or archiving that are intended for regulatory submission or to support regulatory decisions.
To ensure data accuracy and integrity, computerized systems used in laboratories must comply with GLP principles for validation, operation, and maintenance. This means that a validation plan is necessary to outline the process, criteria, and procedures for acceptance and revalidation.
In the life sciences industry, computerized systems are essential for maintaining product quality, safety, and efficacy. As such, companies need qualified validation engineers and must adhere to relevant regulations and guidelines like GLP, GMP, and CSV.
It is important to note that computerized systems delivering supporting data, such as temperature and humidity, for GLP studies should also be considered.
Validate your computerized systems to ensure data accuracy and integrity and comply with GLP regulations.
When it comes to GLP regulations, the US, UK, and EU share similar requirements since they're all members of the OECD.
Read also: Computer Software Assurance for Production and Quality Operation
Resource Person: Nathan Roman
