4.2 Preparatory planning
4.2.1 Documentation
Configuration guidelines for the PCS 7 application
Approved specifications are a prerequisite for configuring a PCS 7 plant in the GMP
environment. Projects of this type generally follow the GAMP5 approach. The objectives in the
GAMP5 documents include: "Guide aims to achieve process control systems that are fit for
intended use and compliant with applicable regulations; providing recommended good practice
based on a life cycle approach for the development, maintenance, and management of process
control system.".
Adherence to the guidelines has a positive influence on the following aspects:
● Compliance with legal regulations
● Quality of the products
● Production efficiency
● Cost savings
Even in projects where there are less legal regulations to be complied with and not as many
high requirements related to quality and efficiency, a similar approach (e.g. the so-called GAMP
light) must be applied whereby only terms and phases from GAMP5 are used.
Preparation and administration
4.2 Preparatory planning
Compendium Part A - Configuration Guidelines (V8.2)
Configuration Manual, 08/2016, A5E38166869-AA 15
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