Product Life Cycle Management (PLM) includes the entire lifecycle of a product from its conception, through design and manufacture,
to service and disposal.
Products which have been put on the market change over time and this process must be managed as it moves through its succession of stages. In the pharmaceutical industry clear guidance is given on types of variations and dossier requirements (Regulations (EC) No 1084/2003 and (EC) No 1085/2003).
For products registered via MRP or DCP any variations must be submitted simultaneously to the competent authorities in the Member States where the product is on the market. Marketing authorisation holders should have a functioning change control system in order to master the variation process and stay in compliance. The use of change control software solutions can facilitate effective control of all post-registration changes to documents.