P&E Systems Ltd are a UK based specialist designer and manufacturer

of process control instrumentation, motor control and PLC systems.

Gamp...

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.

 

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