Document Library
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FDA Guidance: Computer Crossmatch, 4/11
This April 2011 FDA guidance aims to assist blood establishments performing compatibility testing using a computer crossmatch system in cGMP compliance.
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CSV Template – 21 CFR Part 11 Assessment
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.
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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.
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CSV Template – Functional Requirements Specification
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.
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CSV Template – Installation Qualification (IQ)
The IQ documents the installation, configuration and associated verification of a system, system components, or supporting peripherals.
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CSV Template – Meeting Agenda
The meeting agenda template provides a quick mechanism to communicate the key elements and logistics of a meeting.
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CSV Template – Meeting Minutes
Meeting minutes are a key communication tool for any project. This template provides an easy format for recording attendance, discussion, activities, and action items.
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CSV Template – Periodic Validation Review Report
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.
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CSV Template – Project Plan
The Project Plan template documents the project’s business case, scope, deliverables, organization, budget, milestones, schedule, work breakdown structure, and controls.
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CSV Template – Spreadsheet Validation
Spreadsheet Validation Template for concise and compliant documentation of validation plan, activities, and results. Also suitable for validation of reports, queries and calculations.
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CSV Template – System Design Document
The System Design documents how the system will meet the FRS through design of system architecture, data structures, data flows, features, and interfaces.
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CSV Template – Testing Plan
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.
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CSV Template – Testing Summary
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.
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CSV Template – Trace Matrix
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.
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CSV Template – User Requirements Specification
The URS communicates the business’ needs and intended uses of the system to the technical community. Include requirements for data, features, performance, etc.
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CSV Template – Validation Incident Report (v 1)
This Validation Incident Report is used to document validation testing incidents and associated impact assessments, corrections, and verification activities. Detailed version.
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