Abstract: The invention relates to a multi-site production system for production of a product under regulated conditions comprising at least two production sites (12) linked to a central monitoring unit (10), each production site (12) comprising at least one production unit (16) for production under regulated conditions and a computerized control unit (14) designed to receive, possibly record, and transfer required product and/or process parameters to the central monitoring unit (10) designed to check for validation purposes the production process and/or product quality. The invention further relates to a method for multi-site production under regulated conditions making use of above system.

Abstract: The present invention proposes a method for managing tasks of a given recipe to be carried out by at least one operator in a regulatory environment, whereby the operator receives from a computer system voice commands to execute the tasks of the recipe, the operator executes the tasks, the operator verbally reports to the computer system on the task execution and The task execution is verified by the computer system.

Abstract: Example methods, apparatus and system are disclosed relating to a facility for formulating Cell-Based Medicinal Products (CBMPs) in a site where the facility is moved and CBMP formulations are administered. An example facility includes a unitary structure that is assembled together with a vehicle and that houses the working areas and equipment allowing operators to store, count, test, sample, formulate, and/or package CBMPs according to Good Manufacturing Practices. The teachings of the present disclosure relate to a method of providing formulations of a Cell-Based Medicinal Product in sites where the formulations are administered to patients, and from where the facility may be quickly relocated.