Package – Validation Templates and Quality SOPs – Complete Package

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.

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

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. Includes details on the impact to validation testing and documentation.

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.

Defines the procedures and controls necessary for the audit trails within systems used in regulated activities. Includes audit trail archival, periodic review, etc.

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 controls for managing changes to regulated systems. Includes change request, impact assessment, authorization, cancellation, retention, and emergencies.

Procedures and controls for managing the SOPs for systems used in regulated activities. Includes SOP preparation, approval, periodic review, access, retention, and training.

Defines the procedures for managing incidents regarding systems used in regulated activities. Includes incident reporting, investigation, resolution, periodic review, etc.

Outlines the quality assurance approach to audits and assessments of software suppliers. SOP is intended to be used with the Software Vendor Assessment template.

Defines the controls needed to secure the systems, records, and data used in regulated business. Includes physical security, configuration protection, passwords, and more.

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. Includes backup schedules, content, review, and verification.

This SOP defines the procedures and controls needed to recover the Information Technology infrastructure in the event of a system failure or disaster.

The FRS documents the functionality required for intended use of the system. It contains detailed feature list and will be used in development, configuration, and test creation.

The IQ documents the installation, configuration and associated verification of a system, system components, or supporting peripherals.

This template documents the assessment of a system for compliance to 21 CFR Part 11. Template includes 37 questions with cross-references to 21 CFR Part 11.

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 OQ/PQ Validation Protocol is used to document the system's ability to meet the functional requirements specifications (OQ) and user requirements specifications (PQ).

The Testing Plan is used to document the validation testing methodology, strategy, tools, environments, and responsibilities. It includes the plan for IQs, OQs, and PQs.

The Trace Matrix documents the adequacy of test coverage by mapping the links between user requirements, functional requirements, and tests, e.g. OQs and PQs.

The URS communicates the business' needs and intended uses of the system to the technical community. Include requirements for data, features, performance, etc.

The Validation Plan describes the validation deliverables, testing approach, and schedule. It also defines responsibilities for creating and approving each validation deliverable.

The Validation Master Plan (VMP) describes the organization’s overall strategy, approach, and responsibilities for validation of computer systems and software.

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. Detailed version.

This Validation Incident Report template is used to document the occurrence and resolution of incidents encountered during software validation testing. Basic version.

The Testing Summary documents the results of the validation testing. It includes the testing strategy, IQ, OQ, and PQ results, analysis of failures, and testing conclusion.

The Vendor Assessment is used by auditors to evaluate a software supplier. Template includes over 250 specific vendor assessment questions from 83 inspection categories.

Spreadsheet Validation Template for concise and compliant documentation of validation plan, activities, and results. Also suitable for validation of reports, queries and calculations.

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.

Meeting minutes are a key communication tool for any project. This template provides an easy format for recording attendance, discussion, activities, and action items.

The Periodic Validation Review (PVR) Report template SOP is used to document the assessment of a system’s current validation state and plan for closure of any gaps.