Validation of Commercial Off-the-shelf Computer Systems

Describes procedures for the validation of commercial computer systems as required by regulated healthcare industry.

Author: Dr. Ludwig Huber
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Source: LabCompliance

Price: $49.00
Product Details

Product Provides:

  • Overview of validation principles Responsibilities.
  • Planning computer validation activities.
  • Setting specifications Qualification of the vendor Installation and configuration.
  • Testing prior to use (Operational qualification) Testing during use (Performance qualification)
  • Change control Validation report
  • Validation of existing systems
Two attachments with templates for easy implementation.


  • Software and computer systems should be validated for compliance and business reasons.
  • Validation helps to generate accurate, reliable and consistent analytical results.
  • This SOP gives guidelines on how to validate computer systems.


  • Validation of computer systems that have an impact on product quality.
  • Validation includes all life cycle phases from system planning to retirement.
  • The focus is on validation of commercial off-the-shelf system planning to retirement.
  • Exceptions to this procedure are possible but should be based on risk assessment and justified, documented and approved by operation�s management and QA.

Top Reviews

Amazingly concise and to the point! Ron Sanchez Validation Technician BioTeknica BSCi. Miami
-Ronald Sanchez

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