BioKinetyc GxP Quality & Pharmacovigilance Suite
Configure your facility for rapid batch release.
Create your Qualified Person (QP) or Principal Investigator administrative credentials. Our GxP onboarding team will provision your sovereign Azure/AWS partition, connect your Waters Empower or Agilent OpenLab feeds, and issue your IQ/OQ/PQ validation pack.
Included in Your 30-Day GxP Sandbox
- Full AssayVision™ (SpectraViT-QC-v4): Live HPLC chromatogram anomaly detection, dissolution curve verification, and tablet coating defect triage in < 340ms.
- VigilanceSentinel™ MedDRA-NLP-v3: Automated adverse-event extraction, CYP450 polypharmacy risk scoring, and ICH-E2B(R3) safety XML export.
- TrialEscrow™ Multi-Currency Vaults: Dedicated USD & NGN virtual escrow accounts for clinical investigator milestones and raw API letters of credit.
- DossierLex™ & 21 CFR Part 11 Vault: Automated NAFDAC / WHO-GMP Common Technical Document compilation with immutable electronic signatures.
Full IQ/OQ/PQ documentation included • Zero upfront card required
Trusted by 21 Pharma CMOs, Labs & CROs3,400+ Active Batch & Trial Protocols