Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.

A checklist of how to achieve regulatory compliance by validation of laboratory information management systems. Validation costs and cost-effective validation strategies are considered for pharmaceutical manufacturers to validate their systems and maintain a validated state for continued compliance.

Understandably, the thought of implementing a closed-loop PAT strategy throughout the global enterprise and for all products can keep pharmaceutical executives awake at night.

Missed or late calibration dates can accumulate, and even if the equipment is labelled appropriately, it can suggest poor management of resources and priorities.

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.

In applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure.

In applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure.

Exploring a simple and systematic approach to validating an FMS.