Ensuring software complies with 21 CFR Part 11 and GAMP 5 through validation protocol development and lifecycle management.
Full lifecycle qualification of GMP equipment and utilities with VMPs, URS, IQ, OQ, PQ, and validation reports.
Expertise in DeltaV, MES, SCADA, HMI, and PLC systems for manufacturing and lab environments.
Airflow visualization studies in cleanroom and sterile manufacturing environments.
Tailored packages for validation, security, backup, and compliance reporting in GxP cloud environments.