Swift Pharmaceuticals
GxP compliance requirements not being met by existing IT infrastructure, jeopardizing FDA audit readiness and delaying drug approval timelines.
The Challenge
GxP compliance requirements not being met by existing IT infrastructure, jeopardizing FDA audit readiness and delaying drug approval timelines.
Our Solution
Byteflu built a GxP-qualified cloud environment on AWS with validated systems, implemented comprehensive audit trails, and established computer system validation (CSV) processes aligned to 21 CFR Part 11 requirements.
Services Deployed
- Defensible Cybersecurity
- Cloud Services
Our Approach
- 1
Gap analysis against 21 CFR Part 11 and EU Annex 11 requirements
- 2
Designed and deployed GxP-qualified AWS landing zone with audit logging
- 3
Implemented electronic signatures and immutable audit trails
- 4
Established CSV procedures with IQ/OQ/PQ documentation
- 5
Trained R&D and QA teams on validated system usage and deviation reporting
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