Performance and security of a laboratory information mangement system (LIMS)

Deploying a Laboratory Information Management System (LIMS) involves much more than signing a set of specifications and briefly checking functionality once the software has been installed.

In the context of Industry 4.0, where data reliability is becoming a major issue, so that any company can add value to it, and use it to make the right decisions, its veracity needs to be demonstrated at all times.

In another context, where the risk of malicious intent hangs over every company in every sector, the security and safety of the information systems that process this data must also be guaranteed.

This article proposes a methodology for laboratories wishing to set up a LIMS, or to maintain an existing LIMS, which will enable them to maintain data quality, and to optimize the security of the information systems interacting with the LIMS.

This methodology is characterized by a project approach, and by a qualification process, from design to performance. Standards, beyond their normative nature, provide invaluable assistance in implementing this methodology. In a way, their recommendations are no more and no less than proposals arising from a risk analysis in a given activity: quality, environment, calibration and testing, or medical biology laboratories. The proposed approach is also designed to keep LIMS maintenance agile.

IT security requirements are also addressed. The essential points to be taken into account, particularly in the case of outsourcing, are presented. The skills of an information systems security manager will help ensure the success of the implementation phase.

This article will not go into the specific requirements of medical device software, although the qualification process can be applied to them, as well as the tools proposed to ensure traceability of the qualification process.