Compliance

cGMP Compliance

Current Good Manufacturing Practice compliance

cGMP Compliance

Clarix supports compliance with 21 CFR Parts 210 and 211 — the FDA regulations governing Current Good Manufacturing Practice for drug manufacturing.

Key cGMP Areas

Production Controls (21 CFR 211.100–211.115)

Requirement	Clarix Implementation
Written procedures (SOPs)	Document control module with version control
Master production records	Formula module with versioned MFRs
Batch production records	Digital batch records with step-by-step execution
Process validation	Protocol management in documents module
Change control	Quality management change control workflow

Laboratory Controls (21 CFR 211.160–211.176)

Requirement	Clarix Implementation
Testing and release	Lab samples module with pass/fail determinations
Stability testing	Sample lifecycle with time-point tracking
Reference standards	Equipment module tracks reference standard inventory
OOS investigation	Quality module with structured investigation workflow

Packaging and Labeling (21 CFR 211.122–211.137)

Requirement	Clarix Implementation
Label content	Auto-generated labels with required elements
Label verification	Pharmacist verification step before printing
Lot numbering	Auto-generated lot numbers with format control
Expiry dating	BUD auto-calculated per USP category

Records and Reports (21 CFR 211.180–211.198)

Requirement	Clarix Implementation
Batch records	Immutable digital batch records with full audit trail
Distribution records	Planned: distribution tracking with lot traceability
Complaint files	Adverse event reporting in quality module
Annual product review	Quality management reporting module

Personnel (21 CFR 211.25–211.34)

Requirement	Clarix Implementation
Qualification	Training module tracks all personnel qualifications
Training	Competency assessments and SOP training tracking
Supervision	Role-based access ensures appropriate oversight
Hygiene	Garbing and gowning qualification tracking

Equipment (21 CFR 211.63–211.72)

Requirement	Clarix Implementation
Calibration	Calibration scheduling and record tracking
Maintenance	Preventive maintenance scheduling
Cleaning	Cleaning logs with agent rotation
Qualification	IQ/OQ/PQ documentation management

Data Integrity (ALCOA+)

Clarix's data architecture enforces ALCOA+ principles:

Principle	Implementation
Attributable	Every record linked to authenticated user
Legible	Digital records — no handwriting interpretation
Contemporaneous	Timestamps at point of action, not after the fact
Original	Source records preserved, never overwritten
Accurate	Auto-validation, tolerance checking, barcode verification
Complete	Required fields enforced, no partial record submission
Consistent	Standardized workflows prevent variation
Enduring	PostgreSQL with backup and retention policies
Available	Full-text search, export, and on-demand access

USP 797

Sterile compounding standards compliance

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cGMP Compliance Key cGMP Areas Production Controls (21 CFR 211.100–211.115)Laboratory Controls (21 CFR 211.160–211.176)Packaging and Labeling (21 CFR 211.122–211.137)Records and Reports (21 CFR 211.180–211.198)Personnel (21 CFR 211.25–211.34)Equipment (21 CFR 211.63–211.72)Data Integrity (ALCOA+)