Our Services
Quality Auditing
Quality Auditing
Our highly-experienced auditing specialists will audit the quality systems in your facility against statutory regulations from any country/regional authority.
We will assess your existing Validation documentation and recommend remediation activities to supplement your existing Equipment or Computer System Validation documentation
Our services include compliance with Corporate and Local site policies and procedures regulations from the following agencies:
- US Food and Drug Administration (FDA)
- The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)
- European Union (EU)
- Ireland’s Health Products Regulatory Authority (HPRA)
Other Services
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Computer System Validation
Our computer systems validation experts will provide a detailed and expert assessment
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48 Hour Review
Rapidly assess your validation deliverables within 48 hours
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21 CRF Part 11
Protecting the electronic data within your systems by ensuring it is compliant with 21 CFR Part 11 regulations
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