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Professional Services - FDA Validation and Software QA
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| We have the technical
expertise to perform an independent software validation
of your EAM/CMMS. |
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Validation master plans
We will assist in developing your master validation
plan and provide project management services throughout
the validation process.
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Specification document preparation
We can provide the necessary documentation for software
functional requirements and specifications that will
meet the cGMP requirements set by the FDA.
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IQ, OQ, and PQ qualification testing
We can provide installation, operational, and performance
qualifications documents; execute prepared testing plans;
and prepare acceptance and deviation reports.
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Vendor qualification audits
We can conduct software vendor qualification audits
and document quality standards and processes used during
development and testing of the software.
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Final validation reports
We can compile all documentation into a final validation
report to be submitted for FDA validation of the software.
The report will include all specification, qualification
and test documents, risk analysis, and any other documentation
needed to comply with FDA guidelines.
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For more information on DPSI professional services,
please call 800-897-7233 or e-mail sales@dpsi.com |
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