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MGD Services, Inc. The IT Quality Assurance FDA Validation Specialists Phone: 877-MGD-TEST (877-643-8378) Email: [email protected] Web Site: http://mgdservices.com. Running with Technology. FDA Validation Overview. - PowerPoint PPT Presentation
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The IT Quality Assurance
FDA Validation Specialists
Phone: 877-MGD-TEST (877-643-8378)
Email: [email protected] Web Site: http://mgdservices.com
Running with Technology
MGD Services, Inc.
FDA ValidationFDA ValidationOverviewOverview
All systems that require All systems that require compliance with FDA compliance with FDA guidelines must go through guidelines must go through the validation process which the validation process which ensures compliance. ensures compliance.
Validation Task ListValidation Task List
Validation Master PlanValidation Master Plan
Validation LibraryValidation Library
SOP’sSOP’s
Compliance ReviewsCompliance Reviews
Traceability MatrixTraceability Matrix
IQ/OQ & PQIQ/OQ & PQ
21 CFR Part 1121 CFR Part 11
Validation Summary ReportValidation Summary Report
Validation Validation DocumentationDocumentation
All software systems that are All software systems that are developed or used for FDA developed or used for FDA submissions or systems that are submissions or systems that are used with medical devises are used with medical devises are subject to review by the FDA. All subject to review by the FDA. All phases of the Project Life Cycle are phases of the Project Life Cycle are required to maintain FDA required to maintain FDA validation documentsvalidation documents
Overall DesignOverall DesignDocumentationDocumentation
The documentation necessary to
support the overall design of
the system to be validated.
Project ManagementProject ManagementDocumentationDocumentation
The management team for the
project will be required to
maintain project level
documentation as well as to
establish regularly scheduled
project meetings.
HardwareHardware Documentation Documentation
All of the hardware required to support the software systems will be required to maintain installation and operational documentation.
DatabaseDatabase Documentation Documentation
The database that supports the applications must maintain documentation that supports the design and capabilities of the database.
ReportsReports Documentation Documentation
The reports that are generated by the system users require supporting documentation on the setup and capabilities of the reports.
Quality AssuranceQuality Assurance Documentation Documentation
The largest area that requires good solid documentation is Quality Assurance. Before the system can be validated the system must be tested and all supporting test documentation must be maintained.
Change ControlChange Control Documentation Documentation
The change control for the system under development is critical. All changes must be documented and all supporting documentation must be maintained in the validation library.
21 CFR Part 1121 CFR Part 11 Documentation Documentation
This aspect of FDA validation has moved to the forefront of the development process. Keeping the documentation necessary to support electronic signatures is critical.
ValidationValidation Auditor Auditor
Develops FDA validation guidelinesDevelops FDA validation guidelines
Writes Validation PlanWrites Validation Plan
Performs compliance reviews Performs compliance reviews
Assists all project team members in Assists all project team members in establishing complianceestablishing compliance
Performs all other compliance activities necessary
In ClosingIn Closing......
Ensuring FDA validation and compliance for our clients development projects enables the project to pass any FDA validation audit, thereby ensuring the system is moved into production on time.
MGD Services, Inc.P: 877-MGD-TEST
Web: mgdservices.com
E-Mail: [email protected]
