Industrial Automation

BNC ENGINEERS

Computer system validation

COMPUTER SYSTEM VALIDATION

BNC ENGINEERS is one of the leading validation consulting organizations in India and provides total regulatory compliance solutions all over the globe.
BNC ENGINEERS is active and take care of all compliance and help you to set great process to achieve-maintain, and improve GxP compliance in various organization like Life science, Healthcare, Pharmaceuticals, Clinical research industries, Medical device manufacturing, Automation companies, OEM machine and IT-Software developing organization.

We covered following protocol under CSV Validation:

  • Validation Master Plan.
  • Risk Assessment Plan and Report.
  • User Requirement Specification (URS).
  • Functional Specification.
  • Design Specification.
  • Infrastructure Qualification and Report.
  • Installation Qualification Protocol and Report.
  • Operational Qualification Protocol and Report.
  • Performance Qualification Protocol and Report.
  • Validation Summary Report.
  • Traceability Matrix.
  • Assessment of Compliance with regulation ES-ER (21 CFR Part 11).
  • Supplier Assessment Report.
  • Periodic Review.

We provide following CSV Validation services:

  • EMS (Environment Monitoring System) & BMS (Building Management System) Software Validation.
  • PROCESS CONTROL SYSTEM VALIDATION Like PLC/HMI/IPC/SCADA/DCS system validation.
  • Pharma Serialization/Aggregation Validation software, TraceLINK, Track and Trace system, Warehouse management software and Labeling system validation.
  • Analytical Software Validation like SAS, WinNonlin, Chromeleon and more.
  • Laboratory Equipment Software validation like HPLC, GC, LCMS-MS, UV, PH meter, FTIR and more.
  • ERP Software Validation.
  • SAP Software Validation.
  • CSV Documents review, Provide documentation support (Design in-house documents).
  • CSV Audit & CSV Training.
  • Manufacturing Execution System (MES) validation.
  • IT Infrastructure, Server Validation, Network Validation, Cloud based Validation.
  • LIMS, Lab View a& EMPOWER software validation.
  • Any Customized Software Validation.
  • Excel sheet/Spreadsheet Development and Validation.
  • GAP Assessment/ GXP Assessment/ 21 CFR Part 11 Assessments.
We provide CSV Validation protocol as per internationally accepted GAMP#5 guideline and its Risk based approach for Computerized System Validation and its Life Cycle Management Philosophy.