On my current project, my client has a Site Security System. The system includes software, card readers, and lock mechanisms, the requisite SOPs, etc.
Each employee is issuesd a badge and based on their training (not directly connected to training software) they are granted access to some areas of the plantsite (labs, manufacturing areas, etc.). In the office areas they badge in and out regardless of training. The system keeps track 9electronically) of everyone’s comings and goings.
My client manufactures non-sterile, OTC, oral dosage pharms.
There is currently a significant debate re: the need/no need to validate this system…I would like to hear opinions from the experts.
Thanks,
Ken