Computerized System Validation (CSV)

Ensuring your computer systems operate accurately, reliably, and in full compliance with industry standards and regulatory requirements

Comprehensive CSV Services

Full validation services across all regulated industries

HPLC, GC, FTIR, Spectrometer, EMPOWER, UV, LCMS-MS, Chromeleon

SaaS, SAP, ERP, MES, LIMS, TMS, QMS, E-DMS

Environment Management System (EMS) Validation

Cloud, Server, Network Validation, Desktop Validation

Track & Trace, L1 to L5 Integration, Warehouse Management

IQ, OQ, PQ Services

CFR Title 21 Part 11 Compliance

Comprehensive validation framework to achieve and maintain GxP compliance throughout the computerized system lifecycle

Validation plans and reports providing disciplined and consistent approach to meeting regulatory requirements

System validation ensuring accuracy, reliability, and ability to discern invalid or altered records (Ref: 21 CFR 11.10(a))

Complete validation of hardware, software, network components, and controlled functions (Ref: ISPE GAMP5)

Complete documentation suite for regulatory compliance

Specialized validation services across regulated sectors

Comprehensive coverage of global regulatory requirements

FDA

Electronic Records & Electronic Signatures - Validation of systems to ensure accuracy, reliability, and ability to discern invalid or altered records

FDA

Quality System Regulation - Software validation and risk analysis for medical devices

FDA

cGMP for Finished Pharmaceuticals - Computer input/output accuracy verification

ICH

GMP for APIs and Good Clinical Practice electronic trial data handling

PIC/S

Blood Establishments and Distribution Practice validation requirements

Partner with Cloudserve Systems for comprehensive CSV services that ensure regulatory compliance and operational excellence