With a risk-based approach, we comprehensively manage equipment, processes, HVAC, water systems and computerised systems.
URS · RA · DQ · IQ · OQ · PQ — the complete qualification cycle, including utilities.
Complete PV lifecycle management with traditional and continued process verification (CPV) approaches.
Risk-based cleaning validation strategy, sampling plan and limit setting.
Risk-based CSV (GAMP 5) compliant with Annex 11 and 21 CFR Part 11.
GDP-compliant qualification of transport processes, including the cold chain.
Preparing and managing comprehensive site- and project-level VMPs.
Cleanroom HVAC qualification and integration with environmental monitoring programmes.
Preparing and implementing a site-wide CCS under the revised Annex 1.
Let's start with a validation master plan (VMP), risk assessment and prioritisation.