Supply Chain for Pharmaceuticals
GMP-compliant operations with serialization support, cold chain monitoring, and controlled substance tracking.
Pharmaceutical supply chains face the most stringent regulations in any industry—FDA, DEA, GMP, DSCSA, and more. Patient safety and regulatory compliance are non-negotiable. Our Pharmaceuticals Industry Pack provides the features pharma manufacturers, distributors, and pharmacies need: GMP compliance workflows, serialization support (DSCSA roadmap), cold chain monitoring, controlled substance tracking, and clinical trial inventory management—built for an industry where compliance isn't optional.
Pharmaceuticals-Specific Challenges We Solve
The Challenge:
FDA GMP regulations require documented procedures for every operation. Manual documentation is time-consuming and error-prone. Audits require instant proof of compliance.
Our Solution:
- Standard Operating Procedures (SOPs) - Link transactions to SOPs (document management)
- Reason Code Mandatory - Require reason codes for all transactions
- Dual Verification - Require two users to verify critical operations
- Electronic Batch Records - Document production batches with complete traceability
- Deviation Management - Document and investigate any deviations from SOPs
- Change Control - Track all changes to procedures with approval workflows
- Audit Trail - Complete, immutable record of all operations with timestamps and users
The Challenge:
Drug Supply Chain Security Act (DSCSA) requires unit-level serialization and traceability. Must track unique serial numbers from manufacturer through distribution.
Our Solution (Roadmap 2026):
- Serial Number Capture - Record unique serial numbers at receipt
- Aggregation Hierarchy - Track serials → cases → pallets → shipments
- Transaction History (T3) - Complete transaction history per serial
- EPCIS Integration - Electronic Product Code Information Services
- Verification - Verify serial legitimacy before distribution
- Suspect/Illegitimate Tracking - Quarantine and report suspect product
- DSCSA Reporting - Generate required transaction information, transaction history, transaction statement
The Challenge:
Vaccines, biologics, and insulin require continuous temperature monitoring. Temperature excursions risk product efficacy. Must document cold chain for regulatory compliance.
Our Solution:
- Temperature Requirements - Define required storage temperature range per product
- Cold Storage Locations - Designate refrigerated (2-8°C) and frozen (-20°C or -80°C) bins
- Temperature Logging - Integration-ready for IoT temperature monitors
- Excursion Alerts - Real-time alerts when temperature out of range (integration)
- Excursion Documentation - Record temperature excursions with investigation and disposition
- Cold Chain Shipping - Require temperature monitoring for cold chain shipments
- Validation Data - Store temperature logs as attached documents
The Challenge:
DEA requires perpetual inventory for Schedule II-V controlled substances. Manual narcotic counts fail audits. Missing controlled substances trigger DEA investigations.
Our Solution:
- Controlled Substance Flag - Tag Schedule II-V products for special handling
- Perpetual Inventory - Real-time quantity tracking with no grace period
- Reason Code Mandatory - All controlled substance transactions require reason codes
- Dual Count Required - Two users must verify all controlled substance transactions
- Separate Location - Option to store controlled substances in secured vault location
- DEA 222 Form Tracking - Document DEA order forms for Schedule II (integration)
- Biennial Inventory - Generate DEA-required biennial inventory reports
- ARCOS Reporting - Automation Controlled Substances Ordering System reporting (integration)
- Discrepancy Alerts - Immediate alerts for any inventory discrepancies
The Challenge:
Clinical trials require tracking investigational drugs separately from commercial. Must maintain chain of custody. Must track dispensed vs. returned inventory per patient/site.
Our Solution:
- Clinical Trial Projects - Separate inventory pools for each clinical trial
- Site Allocation - Allocate investigational product to trial sites
- Patient-Level Tracking - Track which patient received which lot/serial
- Blind/Unblind Control - Restrict access to blinded investigational product identities
- Dispensing Records - Complete documentation of what was dispensed to whom
- Return Management - Track unused investigational product returned from sites
- Destruction Documentation - Document destruction of investigational product
- Regulatory Reporting - Export data for IND/NDA submissions
The Challenge:
Hospital pharmacies distribute to patient care areas. Need to prevent expired medication administration. Need to track high-alert medications separately.
Our Solution:
- Formulary Management - Use stocklists to define hospital formularies
- Automated Dispensing Cabinet (ADC) Integration - Ready to integrate with Pyxis, Omnicell (roadmap)
- High-Alert Medication Tracking - Flag and separately track high-alert meds
- Expiry Prevention - FEFO enforcement prevents expired medication distribution
- Unit Dose Tracking - Track individual unit doses if needed
- Patient Charge Capture - Link medication dispensing to patient billing (integration)
- Medication Reconciliation - Support medication reconciliation workflows
The Challenge:
Pharmaceutical products have defined shelf life from manufacturing date. Stability studies determine expiry. Must prevent dispensing expired or soon-to-expire products.
Our Solution:
- Shelf Life Calculation - Calculate expiry date from manufacturing date + shelf life
- Retest Dates - Track retest dates for APIs and intermediates
- Expiry Extension - Document approved expiry extensions with reason
- Quarantine Near-Expiry - Automatically quarantine products within defined window of expiry
- Short-Dated Inventory - Flag and manage short-dated inventory (< 6 months remaining)
- Expiry Risk Analytics - Dashboard showing expiring inventory by value and criticality
Pre-Configured Pharmaceuticals Roles
- QC Analyst - Quality control testing, accept/reject decisions, CoA generation
- QA Manager - Quality assurance oversight, deviation management, change control
- Regulatory Affairs - Compliance reporting, serialization, DSCSA, audit support
- Supply Chain Manager - Purchasing, supplier quality, distribution, forecasting
- Warehouse Supervisor - Receiving, putaway, picking, shipping, cold chain monitoring
- Clinical Supply Manager - Clinical trial inventory, site allocation, patient tracking
- Pharmacy Director - Hospital pharmacy operations, formulary management, compliance
- Controlled Substance Coordinator - DEA inventory, Schedule II-V tracking, reporting
Pharmaceuticals Compliance Features
- FDA 21 CFR Part 11 - Electronic records and signatures (roadmap)
- GMP (Good Manufacturing Practice) - Documented procedures, audit trails, change control
- DSCSA (Drug Supply Chain Security Act) - Serialization and traceability (roadmap 2026)
- DEA - Controlled substance perpetual inventory and reporting
- EU GDP (Good Distribution Practice) - European distribution standards
- VAWD (Verified-Accredited Wholesale Distributors) - NABP accreditation support
- State Board of Pharmacy - State-specific pharmacy regulations
- HIPAA - Patient data protection when linked to patient systems
"We're a specialty pharmaceutical distributor handling oncology drugs, many of which are controlled substances requiring cold chain storage. Our biggest regulatory risk was DEA compliance on controlled substances—any discrepancy triggers an investigation. We implemented this system with the Pharmaceuticals Industry Pack and enabled dual verification for all controlled substance transactions. Within 6 months, our controlled substance inventory accuracy improved from 98.2% to 99.97%. During our last DEA audit, we provided the auditor with complete transaction history, perpetual inventory records, and biennial inventory in under 30 minutes. The auditor commented it was the cleanest audit he'd conducted in years. When DSCSA serialization becomes mandatory, we're ready with a platform that's built for it."
— VP of Regulatory Affairs, Specialty Pharma Distributor
Deployment Timeline
Setup & Import
Activate Pharmaceuticals Industry Pack, import locations (warehouses, cold storage), import product catalog with controlled substance flags and temperature requirements
Configuration
Configure cold storage bins, controlled substance vault, dual verification workflows, train QC and warehouse staff
GMP Workflows
Configure GMP workflows, SOPs, reason codes, deviation management, train all staff on compliance procedures
Go Live
Go live with full GMP workflows, parallel run for one production cycle to validate compliance
Achieve GMP Compliance with Confidence
See how leading pharmaceutical companies maintain regulatory compliance with automated audit trails and serialization-ready architecture.