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Computer Systems Validation


  • Computer Systems facilitates the process control, monitoring in manufacturing areas as well as environment condition monitoring in storage areas.
  • Computer Systems are used to create, modify, maintain, store, archive, retrieve, transmit the data.
  • Any computer system used for above functionality in pharmaceutical industry must be validated as per GAMP 5 guidelines.

CSV following GAMP 5 guidelines ensures that :

  • The users and suppliers work together to understand the individual's responsibility regarding validation.
  • Documented assurance is provided to the user that the system is appropriate for intended purpose before actual use of system in process.
  • Suppliers verifies the system to eliminate the avoidable defects in system being supplied.
  • System supplied is as per specifications and regulatory requirements.
  • Computer data is protected from unauthorized changes, access and losses.

Skytech Systems providing below services related to computer system validation

  • Validation Master Plan
  • Comprehensive GAP & RISK Analysis.
  • Most appropriate & latest GAMP, 21 CFR Part 11, EU Annex 11 guideline based Compliance services for your new / legacy systems.
  • Validate Building Management & Environment Control Systems
  • Programmable Logic Control (PLC )
  • Supervisory Control & Data Acquisition (SCADA) Systems
  • Distributed Control Systems ( DCS ).

CSV-Services as per GAMP5-V Model

  • Prepare User Requirement Specifications
  • Perform Supplier Assessment
  • Prepare Functional Requirement Specifications
  • Perform Functional Risk Assessment
  • Design Specifications & Configuration Specifications
  • Validation Protocol
  • Installation Qualification
  • Operational Qualification
  • Assessment for Compliance to 21 CFR part 11 and EU Annex 11 requirements for ER & ES
  • Performance Qualification
  • Validation Summary Report
  • System Release Certificate , Traceability Matrix
  • Periodic Review Report
  • System Retirement Report
  • Excel Sheet Validation
  • Technical support during regulatory compliance audits as per customer requirements
  • Training

Get In Touch

912, infront of ITBP H.Q, Bypass Road, Hanuman Mandir KanaSaiya, Bhopal-462010, M.P. (India)




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