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How to perform Computer System Validation (CSV) – GAMP®5

How to perform Computer System Validation (CSV) – GAMP®5


Any computer-based equipment or fixture that is required for testing or the production of clinical or human use devices must be validated prior to use.  Computer System Validation (CSV) – GAMP5 (Good Automated Manufacturing Practice V-Model), is a guidance per FDA 21 CFR Part 11-820 & IS0-13485.75, that all Biotech and medical device companies usually follow to ensure that their respective testing or manufacturing equipment functions and performs as intended or expected. Through means of proper documentation and traceability each equipment is validated as follows:

Identify the Computer System

  • Identify the equipment used in the manufacturing process. Either it is;
    • New Equipment or recently purchased
    • Used during a development of a new product or manufacturing

Determine the required validation

  • The purpose of the computer system e.g.:
  • Determine if computer system is new or previously validated
  • Store quality records
  • To demonstrate compliance to a regulation
  • To track quality audit details
  • Maintenance of training records
  • Make quality decisions
  • Maintenance of calibration records or tracking of calibration conditions

Validation Scope

Document the category of the equipment

  • Category 1: Infrastructure Computer Software
  • Category 2/3: Products which are used Off-The-Shelf (OTS) or without software
  • Category 4: Computer software that are configured for a specific business operation
  • Category 5: Custom computer software system developed to meet individual user requirements, where there is no commercial Computer software System available.  Note: if the answer to the above questions are NO, the computer software system does not have to be validated.
  • Based on the selected computer system category, validation must be performed per the following deliverables – FAT, SAT, FS, URS, IQ, OQ, PQ, Risk Hazard Analysis

Validate System

  • Capture all pertinent validation deliverables on a computer system validation form
  • Identify the safety, compliance, environmental impact, ergonomics and business risks
  • Execute all documented test cases per the computer system validation plan/protocol
  • Document all the test cases result in the computer system validation report
  • Document any deviations taken from the plan in the deviation section of the computer system validation report
  • Update the software configuration section of the computer system validation report
  • Release the computer system validation report including all pertinent documents that may have been created.

Maintain Validated System

  • Validated computer systems must be retained in a revision-controlled data archive application
  • Revalidate as required if there are any changes to the computer systems or software

For further assistance regarding how to validate your new or existing equipment computer software/systems or commissioning contact us

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