Improving Compliance
The SmartFactory LineClearance Assistant (LCA) includes features which support compliance with 21 CFR Part 11 and EU Annex 11. Industry leading inspection technology ensures that each camera inspection is accounted for before the Line Clearance can be completed. The system builds a bank of evidence each time a line clearance is completed, providing assurance that visual inspections of the line have been conducted correctly.
The digital system allows for full traceability of all inspections and operator activities. SmartFactory LineClearance AssistantTM supports achieving compliance by implementing controls to protect the integrity and the access to the data. Deployment of the system into GAMP 5 environments can be carried out rapidly and risk-free, as a full software validation pack is provided with the system.
Improving Health & Safety
The patent pending LineClearance Assistant technology reduces the health and safety risks to the operators working on the line. The carefully placed vision systems eliminate the requirement for operators to reach high, hard to reach spaces, carry out “blind” checks, and examine low light and dark areas. The technology essentially reduces the operators’ requirement to reach, stretch or crouch to access tight hard-to-reach areas.
High resolution cameras can detect irregularities that the human eye would struggle to see, and a network of cameras provide an overview of the whole line simultaneously, which makes the operators role less hazardous.