Risk Management template

Package – Risk Management

$240.00

Risk Management SOP

SOP System Risk Management

Overall program of procedures and controls for managing quality risks for systems used in regulated activities.  Includes definitions, responsibilities, and approach.

System Risk Assessment SOP

SOP System Risk Assessment

Assess and analyze the quality risk for systems used in regulated activities. Includes risk assessment timing, procedures, criticality, classification, and documentation.

Risk Based Validation SOP

SOP System Risk-Based Validation

Procedure for defining a validation approach based on the risk assessment and vendor audit. Includes details on the impact to validation testing and documentation.

validation template, computer system risk assessment

CSV Template - Computer System Risk Assessment

This form is used to document the system-level and major function-level risk assessment in terms of criticality and complexity.

This system risk management template and SOP package contains the 4 key documents you need for your software QA program.  The package includes a policy level SOP on Risk Management as well as SOPs and a template for system risk assessment and validation.  At $240, this is a 20% savings vs. purchasing the same documents separately!  You get:

  • Risk Management SOP
  • Risk Assessment SOP
  • Risk-Based Validation SOP
  • Computer System Risk Assessment Template
SKU: 60001 Category:

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