Validation package DQ, IQ, OQ for equipment and computer control system on board and in connection with Scada or DCS.
GMP Risk Assessment for equipment and control system as indicate in GAMP 5, 21 CFR p11 assessment.
P.A.T. approach for critical control point as describe in Guidance for Industry from FDA
GAMP 5 approach to development of the entire project (URS - FDS - HDS - SDS).