Validation Templates and Software Quality SOPs
Showing 33–43 of 43 results
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SOP Periodic Validation Review
The Periodic Validation Review SOP defines the steps and process for periodic review of validated systems to ensure that each system remains in a validated state.
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SOP SDLC for Custom Development
This SOP establishes the development life-cycle that is used to guide design, development, maintenance, and retirement of custom developed software systems.
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SOP SDLC for Package Software
Establishes the development life-cycle that is used to guide design, procurement, configuration, maintenance, and retirement of commercial off-the-self (COTS) systems.
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SOP Software Vendor Assessment
Outlines the quality assurance approach to audits and assessments of software suppliers. SOP is intended to be used with the Software Vendor Assessment template.
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SOP System Backup
Defines the controls needed to back up the software and data for use in system restoration or recovery. Includes backup schedules, content, review, and verification.
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SOP System Restore
This SOP defines the procedures and controls needed to recover the Information Technology infrastructure in the event of a system failure or disaster.
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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.
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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.
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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.
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SOP System Security
Defines the controls needed to secure the systems, records, and data used in regulated business. Includes physical security, configuration protection, passwords, and more.
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SOP User Training
Defines the procedures and controls to ensure that employees have the training needed to perform assigned responsibilities regarding systems used in regulated activities.
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