Significance of maintaining Equipment Log Books

As stated in FDA 21, CFR 211.182, “A written record of major equipment, maintenance and use shall be included in individual equipment logs that’s show the date, time, product and lot number of each batch processed”

A manufacturing industry can maintain different set of logbooks depending on the nature of activities being carried out in premises. Such records essentially serve the requirements stipulated by regulatory bodies/GMP and help ensure smooth trouble-free operations. The present article discusses some equipment logbook requirements and outlines their benefits.

Maintaining equipment logbook is vital. Equipment logbook system have a module to capture entire equipment life span considering relevant different process like cleaning, Maintenance and servicing, calibration, verification/qualification, breakdown etc. And those logs can be verified and approved in controlled closed loop workflow. System facilitates users to build various Process formats/equipment process formats into digitally and different manufacturing process can be created with no limitations.

Benefits at glance;

  • Complete visibility on usage and maintenance, cleaning process-oriented logs
  • Near to real time status for equipment usage and availability
  • Enforce controlled validation in batch operations
  • Smart report and trending
  • Equipment/Instrument library management
  • Follow equipment process life cycle