Computer Validation
VTI computer validation engineers will help ensure that your computerized systems are developed and qualified following a structured life cycle approach consistent with the Good Automated Manufacturing Practice (GAMP5) guidance.
A Proven Process that Benefits You
We have developed a process and a suite of services designed to ensure that you are in compliance with the applicable sections of the cGMP/GLP/GCP and 21 CFR Part 11. This process will assure the quality of computerized systems through the development and/or execution of requirements, specifications, design, coding, testing, installation and acceptance. This process includes the following steps customized to your unique needs:
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Supplier/Vendor Audits
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Client Validation Life Cycle Audit
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21 CFR Part 11 Audits/ Remediation Plans
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Policies & Procedures Development
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Software Validation
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Validation Plans
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Disaster Recovery Plans
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Operation & Security SOPs
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Change Management and Control
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System User Requirements and Design Documents
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Protocols, Test Plans, Test Scripts
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21 CFR Part 11 Training
Does your project have a need for Computer Validation? Please Contact Us.