Simplify your next Quality System Inspection

The FDA and other similar regulatory agencies have started to take a top-down, system-based approach to inspections and audits called the Quality System Inspection Technique (QSIT). Instead of looking at the end results of processes for small abnormalities, they are focusing instead on the elements of the total quality system that are most important to meeting requirements.

Reducing the number of systems being used to manage similar activity can greatly simplify future audits, with fewer systems to explain and have inspected. ”Facility and Equipment”, grouped by the FDA into a one of the seven subsystems that make up a complete quality system, is one area that can now be brought into a single system.

In the past, bringing such disparate disciplines as calibration and maintenance together under a single system has been complicated by that fact that each group has their own way of working with assets and data entry requirements. By allowing each group to work their way within a single system, Blue Mountain Regulatory Asset Manager offers a single comprehensive integration software solution to manage your facilities and equipment. The software allows you to track the full life cycle of equipment, from calibration and maintenance to validation.