COMPLIANCE & VALIDATION

PHA.SE. supports its Clients on Compliance and Validation services related to either new systems, equipments and facilities and to existing systems (legacy systems). In particular PHA.SE. develops and manages the following activities:

Compliance & Validation Status Audit
Validation Master Plan
Cleaning Validation
GMP & Compliance Assessment
Risk Analisys
GMP review
Media Fill & Process Validation
Computer System Validation
Process Utilities Validation (PW, WFI & CS)
Design Qualification (DQ) & cGMP Review
IQ/OQ/PQ Protocols and reports for equipments, plants, manufacturing and packaging lines
QA documentation and procedures compiling
SOPs issue and execution (where needed)
Validation Periodic Review
Deviation management