Validation (URS/RA/SI/VMP/VS/VR)

Change Control and C&Q (FAT/SAT/DQ/IQ/OQ/PQ/Maintenance Plans) – design and execution

Validation (URS/RA/SI/VMP/VS/VR)

Change Control and C&Q (FAT/SAT/DQ/IQ/OQ/PQ/Maintenance Plans) – design and execution

Technical Reports and Quality Reviews

Standard Operating Procedures (SOPs)

Computer system validation in accordance with GAMP 5, EU/FDA GMP guidelines

Data integrity strategies design to ensure the compliance of the GxP records to the ALCOA+ principles

Technical Reports and Quality Reviews

Standard Operating Procedures (SOPs)

Computer system validation in accordance with GAMP 5, EU/FDA GMP guidelines

Data integrity strategies design to ensure the compliance of the GxP records to the ALCOA+ principles

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