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Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Addresses the requirements for computer systems validation and includes sections on validation deliverables, roles and responsibilities, and quality assurance controls.
This SOP establishes the development life-cycle that is used to guide design, development, maintenance, and retirement of custom developed software systems.
Establishes the development life-cycle that is used to guide design, procurement, configuration, maintenance, and retirement of commercial off-the-self (COTS) systems. Overall program of procedures and controls for managing quality risks for systems used in regulated activities.  Includes definitions, responsibilities, and approach.
Procedure for defining a validation approach based on the risk assessment and vendor audit. Defines the procedures and controls necessary for the audit trails within systems used in regulated activities.
Defines the procedures for continuity of operations for regulated business functions using computerized systems in the case of computer system failure or unavailability. Defines the procedures for managing incidents regarding systems used in regulated activities. Defines the controls needed to secure the systems, records, and data used in regulated business.
Defines the procedures and controls to ensure that employees have the training needed to perform assigned responsibilities regarding systems used in regulated activities. Defines the controls needed to back up the software and data for use in system restoration or recovery.


This SOP defines the procedures and controls needed to recover the Information Technology infrastructure in the event of a system failure or disaster. The IQ documents the installation, configuration and associated verification of a system, system components, or supporting peripherals. This form is used to document the system-level and major function-level risk assessment in terms of criticality and complexity. The System Design documents how the system will meet the FRS through design of system architecture, data structures, data flows, features, and interfaces. The Testing Plan is used to document the validation testing methodology, strategy, tools, environments, and responsibilities.
The Trace Matrix documents the adequacy of test coverage by mapping the links between user requirements, functional requirements, and tests (e.g. The URS communicates the business' needs and intended uses of the system to the technical community. The Validation Report documents the validation approach and conclusion that the system is certified for operational use based on the validation testing results.
This Validation Incident Report is used to document validation testing incidents and associated impact assessments, corrections, and verification activities. This Validation Incident Report template is used to document the occurrence and resolution of incidents encountered during software validation testing. Spreadsheet Validation Template for concise and compliant documentation of validation plan, activities, and results.
The Project Plan template documents the project's business case, scope, deliverables, organization, budget, milestones, schedule, work breakdown structure, and controls.


The meeting agenda template provides a quick mechanism to communicate the key elements and logistics of a meeting. The Validation Master Plan (VMP) describes the organization’s overall strategy, approach, and responsibilities for validation of computer systems and software. Includes risk assessment timing, procedures, criticality, classification, and documentation.
Includes change request, impact assessment, authorization, cancellation, retention, and emergencies. It contains detailed feature list and will be used in development, configuration, and test creation.
It includes the testing strategy, IQ, OQ, and PQ results, analysis of failures, and testing conclusion. Template includes over 250 specific vendor assessment questions from 83 inspection categories.
This template provides an easy format for recording attendance, discussion, activities, and action items.



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