Pharmaceuticals
Validated Technology for Regulated Life Sciences
Pharmaceutical companies must navigate stringent FDA regulations, manage complex R&D workflows, and ensure product quality at every stage. We provide technology solutions that support drug development, manufacturing, and distribution with full regulatory traceability. Our pharma team is trained in GxP requirements and brings Computer System Validation (CSV) expertise to every engagement.
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Industry Challenges
Our Solutions
How We've Helped Pharmaceuticals Clients
Computer System Validation
Full CSV lifecycle from validation planning through IQ/OQ/PQ execution to ongoing periodic review, meeting FDA 21 CFR Part 11 and EU Annex 11 requirements.
LIMS Integration Testing
Validating Laboratory Information Management Systems across sample management, instrument integration, result calculation, and regulatory reporting workflows.
Drug Supply Chain Serialization
Testing DSCSA-compliant track-and-trace systems for pharmaceutical serialization, aggregation, and verification across the distribution chain.
Why Choose Us for Pharmaceuticals
Services for Pharmaceuticals
Explore the specific services we bring to pharmaceuticals engagements.
Frequently Asked Questions
CSV is a documented process to ensure that computerized systems in regulated environments perform their intended functions reliably and consistently. We deliver the full CSV lifecycle: validation planning, risk assessment, requirements traceability, IQ/OQ/PQ test execution, and periodic review -- all aligned to GAMP 5 and FDA 21 CFR Part 11.
Yes. Our testing validates electronic records and electronic signatures against all Part 11 requirements including audit trails, user authentication, data integrity, system access controls, and electronic signature binding. We also test EU Annex 11 requirements for European operations.
We validate LIMS platforms (LabWare, STARLIMS, Thermo Fisher), clinical trial management systems (Medidata, Oracle Argus), eTMF systems, and pharmacovigilance databases. Our validation approach is risk-based per GAMP 5, focusing testing effort where it matters most for patient safety and data integrity.
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