When required software can be created in accordance with GAMP 5 procedures.
Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff.
Within the supply of a control system, it is essential to document the whole life cycle of software development, against an approved Functional Design Specification (FDS) and validation of the completed system.