
GxP Quality Compliance
For Life Science businesses in highly regulated environments,
compliance is not an option. Prepare to successfully pass audits and inspections for your product with GQC’s tailored and cost-effective programs for Quality Management.
Quality system documentation hierarchy design
Workflow definition & Standard template alignment
Draft procedures with reference applicable standards (GACP, GLP, GCP, GMP, PIC/s, ICH Guidelines etc.)
Inspection Readiness and on site support
Process Validation
Risk Analysis Management
Analytical Method Development and Validation
Cleaning Validation
GxP and ISO certified quality system application
A Global network of local auditors ready to execute audits worldwide operating from PQE subsidiaries and offices
Remote audits whenever on-site audits are not allowed due to restrictions
QMS implementation
QA outsourcing support
GCP Auditing
GCP Inspection readiness