Transcript QUALITY ASSURANCE - MGD Services Inc. | Running with

MGD Services, Inc.
The IT Quality Assurance
FDA Validation Specialists
Running with Technology
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Phone: 877-MGD-TEST (877-643-8378)
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Email: [email protected]
Web Site: http://mgdservices.com
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FDA Validation
Overview
All systems that require compliance
with FDA guidelines must go
through the validation process
which ensures compliance.
Validation Task List
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Validation Master Plan
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Validation Library
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SOP’s
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Compliance Reviews
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Traceability Matrix
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IQ/OQ & PQ
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21 CFR Part 11
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Validation Summary Report
Validation Documentation
All software systems that are developed
or used for FDA submissions or systems
that are used with medical devises are
subject to review by the FDA. All
phases of the Project Life Cycle are
required to maintain FDA validation
documents
Overall Design
Documentation
The documentation necessary to
support the overall design of the
system to be validated.
Project Management
Documentation
The management team for the
project will be required to maintain
project level documentation as
well as to establish regularly
scheduled project meetings.
Hardware
Documentation
All of the hardware required to
support the software systems will
be required to maintain installation
and operational documentation.
Database
Documentation
The database that supports the
applications must maintain
documentation that supports the
design and capabilities of the
database.
Reports
Documentation
The reports that are generated by
the system users require
supporting documentation on the
setup and capabilities of the
reports.
Quality Assurance
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 Control
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 11
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.
Validation
Auditor
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Develops FDA validation guidelines
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Writes Validation Plan
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Performs compliance reviews
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Assists all project team members in
establishing compliance
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Performs all other compliance activities
necessary
In 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]