RECORDS MANAGEMENT & DECOMISSIONING                                                                    

Decommissioning Process

DecommissioningWhat is decommissioning and when is it needed?   “Decommissioning” is a term that defines the formal process of becoming non-active or “out of service”. Decommissioning involves all of the activities necessary when preparing a production plant for a closing, selling or restructuring process. Main activities preceding a decommissioning process   In order to accomplish an efficient and quick decommissioning process, there are several activities which must be carried out before the process starts. These essential activities are:

  • Identification and management of all the GMP documentation associated with equipment, systems and applications in any format or medium (electronic and paper).
  • Identification and management of all GMP data generated during the life cycle of the equipment and systems.

Main activities during a standard decommissioning process:

  • Identification of instruments, equipment, systems and applications to decommission;
  • Classification or categorization of the instruments, equipment, systems and applications according to their complexity and the way in which the information has been stored;
  • Preparation of the decommissioning documents related to instruments, equipment, systems and applications according to their complexity and category:
    • Decommissioning Checklists: these are documents written for non-computerized systems, equipment and applications or for systems which do not store any information;
    • Decommissioning Plans: these are documents written for computerized equipment, applications and systems or systems which store information.
  • Management of the information stored in equipment, systems and applications.