CSV & CQV
project-three-img
Computer System Validation (CSV) Services

Computer System Validation (CSV) Services

R&D Lab & Manufacturing Plant

Ensuring your facility is inspection-ready is a critical step toward regulatory success. Our comprehensive GMP auditing services are designed to assess, identify, and resolve gaps in compliance with international standards, including those set by the US FDA, WHO, EU, and other global regulatory authorities.

  • System Scope: Validation includes ERP Systems, DMS, Network & PC-based Systems, Facility/Utility/Barcode/Warehouse Systems, Building Automation, Maintenance Management Systems, SCADA/PLC/DCS/MES/EBRS systems, and process equipment.

  • Clinical Systems: Validation of eCRF, eSD, eTMF, Patient Databases, IV/WRS systems, data migration plans, and data quality control.

Deliverables

  • Validation Master Plan (VMP)

  • SOPs for CSV

  • URS/SRS – Requirement Specifications

  • Design & Configuration Specs (DCS)

  • Risk Assessments (QRM/RA, FRA)

  • IQ/OQ/IOQ (Installation & Operational Qualifications)

  • RTM (Requirement Traceability Matrix)

  • Validation Summary Report (VSR)

  • Audit trails, logical security, access control, data integrity assessments (DIRA Audit)

  • Spreadsheet (Excel) validation

project-three-img
Computerized Equipment & Software Validation

Computerized Equipment & Software Validation

Validated Systems Include:

Lab Equipment

  • HPLC, GC, FTIR, TOC, Stability Chambers, Muffle Furnace, Humidity Chambers

  • Polarimeter, Dissolution Tester, Sonicator, Refrigerator

Manufacturing Equipment

  • BMS/EMS

  • Water Systems (WFI/PW/EDI)

  • Blenders, FBP/FBD, Compression Machines

  • Rapid Mixer Granulators, Compactors

  • Strip/Blister Packing Machines

  • Vial Washing, Filling, Sealing Machines

  • De pyrogenation Tunnel, Isolators, Lyophilizers

  • ORABS, Manufacturing Vessels, Integrity Apparatus

Application Categories (GAMP 5)

  • Category 1: Infrastructure Software

  • Category 3: Non-configured (firmware, instruments)

  • Category 4: Configured Software (SCADA, ERP, BMS, LIMS)

  • Category 5: Custom Software (internal/external IT apps, macros, PLC logic)

project-three-img
CQV – Commissioning, Qualification & Validation Approach

CQV – Commissioning, Qualification & Validation Approach

Approaches

  • Initial Qualification: Risk Assessment (QRM/RA), IQ, OQ, Validation Summary Report

  • Periodic/Re-Qualification: Re-IQ & OQ based on client policy, with validation summary

  • Addendum-Based Approach: For updates/modifications in hardware/software. Includes documentation and re-validation.

Validation Deliverables (as applicable to PLC, SCADA, Firmware):

  • Design & Functional Specifications (DQ/SDS/FDS)

  • Quality Risk Management (RA/QRM)

  • IQ/OQ/IOQ with detailed test scripts

  • RTM for mapping requirements to test results

  • VSR covering lifecycle, deviations, incidents

  • Gap Assessment, GxP Compliance Check, and Data Integrity Risk Assessment.

Go Back Top