FDA regulations require a computer systems compliance program for all systems used for the discovery, development, manufacture, warehousing, distribution, or quality control of a drug product, substance, or medical device. These regulations, as defined in the Code of Federal Regulations, apply to all FDA-regulated industries.
A significant challenge in complying with FDA regulations is the ability to balance validation needs against limited available resources and overall costs, and to deliver consistent quality, reliability and performance through a proven and reproducible computer systems validation program.
We work with life sciences companies to understand their specific business needs and then provide unique, full life cycle solutions for business processes, regulatory compliance, and information technology. With a highly focused and reliable compliance approach, we offer a proven methodology that translates into measurable business advantages. Our Computer Systems Validation teams will work cohesively with your quality assurance and IT professionals to achieve all of your compliance goals.
Computer Systems Validation Services (CSV)
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Leading teams to write all validation and verification documentation
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Supplying management with a finished product that is ready for FDA inspection
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Defining user requirements and developing project plans
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Developing installation protocols, installation instructions, and verification test plans
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Translating requirements into specifications compliant with 21 CFR Part 11
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Performing process-level risk assessment and hazard analysis
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Developing test plans, executing test cases, and approving test reports
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Approving all project documentation and completing system release
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Validating customer complaint systems
21 CFR Part 11
- Compliance Plan Creation
- Awareness Training & Interpretation
- Risk/Gap Assessments
- Compliance Strategsy & Remediation Planning
- Implementation Service
