Site Services

We provide CSV and compliance services for pharmaceutical and regulated industries, aligned with FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 requirements. Our services ensure data integrity, system reliability, and regulatory compliance throughout the system lifecycle.

Our end‑to‑end CSV offerings include URS, FS/DS, risk assessments, validation plans, SOPs, IQ, OQ, and PQ. We follow a risk‑based validation approach, focusing on functions that impact product quality, patient safety, and data integrity. Special attention is given to audit trails, access controls, electronic records, and electronic signatures.

We support CSV activities across manufacturing systems, LIMS, QMS, ERP, and automation platforms, including inspection and revalidation support.