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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
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
Purpose:
- 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.
Scope:
- 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.
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Top Reviews
Amazingly concise and to the point!
Ron Sanchez
Validation Technician
BioTeknica
BSCi. Miami
-Ronald Sanchez
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