The only platform where your pharmacy can run 42 FDA-mapped compliance tests with one click, generate audit-ready documents in seconds, and prove CGMP validation without external auditors.
External consultants charge premium rates for manual IQ/OQ/PQ execution. Every system change triggers another expensive cycle.
Manual validation requires scheduling auditors, executing protocols by hand, documenting results, and iterating on deviations.
Handwritten protocols, inconsistent test execution, and manual document assembly create audit vulnerabilities.
Between validation cycles, pharmacies have zero visibility into whether their system still meets CGMP requirements.
42 tests. 6 regulatory frameworks.
Audit-ready documents. Zero auditors.
Every workflow a 503A or 503B pharmacy needs, from master formulations to FDA audit documentation, in a single integrated system.
Master formulas with dosage forms, routes, BUD calculations, risk levels, hazardous drug flags, and ingredient tracking per USP 795/797.
Complete batch record lifecycle from initiation through QA review. Lot tracking, yield calculations, and master formula references.
pH, potency, sterility, endotoxin, and visual inspection testing with specifications, results, and pass/fail determination.
Temperature, humidity, viable/non-viable air, surface, and pressure differential monitoring with ISO-classified clean room management.
Equipment registry with calibration certificates, maintenance scheduling, DOP-tested HEPA filters, and cleaning log management.
Immutable, append-only audit trail capturing every action with timestamps, user IDs, and before/after values. 21 CFR Part 11 compliant.
Vendor management with qualification status workflows, COA tracking, and approved supplier lists per CGMP requirements.
Complaint intake with severity classification, root cause analysis, corrective/preventive actions, and resolution tracking.
Claude-powered pharmaceutical assistant with hard guardrail: AI never auto-approves any pharmaceutical decision. Context-aware, compliance-trained.
Database, services, gateway, Redis, system environment
Auth, CRUD, audit trail, security, BUD compliance
Workflows, load testing, ACID transactions, response times
Audit trail, e-signatures, ALCOA, RBAC, timestamps
Traditional CGMP validation costs $50K–$150K and takes weeks. CompoundOS executes 42 tests against your live production system in under one second.
Each test maps to a specific FDA regulation. Results store in an immutable audit trail. Word documents generate on demand for inspector review.
FDA-compliant validation protocols and reports with approval signature tables, test results, regulatory references, and deviation tracking. Generated as Word documents.
Validation Master Plan
Installation Qualification
Operational Qualification
Performance Qualification
Electronic Records
With test results
With test results
With test results
With test results
Validation Summary
Audit trails, e-signatures, access controls, timestamp integrity, ALCOA data integrity, system validation
Batch records, equipment qualification, facility controls, laboratory testing, packaging, labeling, distribution
Formulation standards, BUD assignments, quality testing, personnel training, facility requirements
ISO-classified environments, environmental monitoring, pressure differentials, garbing, media fill testing
NIOSH list management, PPE requirements, containment procedures, decontamination, waste handling
Custom application validation lifecycle, risk-based testing, IQ/OQ/PQ framework, traceability matrix
See CompoundOS run 42 FDA compliance tests against a live pharmacy system in under one second. Schedule your demo today.