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- Overview
- Warehouse Management
- Material Management
- Product Management
- Product Development
- Product QA
- Product Production
- Cross-Platform Features
Overview
Pharma365 is a pharma-grade CRM and operations suite that connects Warehouse, Material, Product, Development, QA, and Production into one compliant, traceable platform. From R&D to commercial batches, every lot, document, and decision stays linked to a single product truth.
Outcomes: faster tech transfer, tighter control of materials and specs, audit-ready records, and reliable release timelines.
Highlights
- End-to-end traceability: lot, batch, equipment, and document lineage
- Role-based workflows with approvals, e-signatures, and audit trails
- Dashboards for inventory health, batch status, deviations/CAPA, and OEE
- Integrations: ERP/MES/LIMS/QMS/CMMS, barcode/RFID, labelers & printers
- GxP-aligned controls (e.g., 21 CFR Part 11/EU Annex 11 features: e-sig, audit logs)
Warehouse Management
GxP-aware inventory and distribution with full lot and expiry control.
Key Capabilities
- ASN receiving, sampling, quarantine/release, and put-away
- FEFO/expiry, cold-chain tracking, bin/location management
- Barcode/RFID, cycle counts, physical inventory, and pick/pack/ship
- Serialization support and COA capture at receipt
- Real-time inventory visibility across sites and contract partners
Value
Reduce stockouts and write-offs; maintain GDP-aligned records ready for inspection.
Material Management
Tight control of specs, vendors, and status from receipt to consumption.
Key Capabilities
- Approved vendor list (AVL), vendor qualification, and supplier scorecards
- Material specs & versions, sampling plans, COA ingest & verification
- Status control (quarantine/approved/rejected), retest dates & holds
- Lot genealogy and full consumption trace into batches
- Automatic triggers: sample pulls, re-testing, and expiry actions
Value
Confident releases with less manual reconciliation and faster investigations.
Product Management
All product master data, SKUs, formulations, and labeling in one place.
Key Capabilities
- Product master, dosage forms, pack types, BOMs & recipes
- Label content control, change history, and print integration
- Specifications and acceptance criteria with versioning
- Country/market variants and regulatory attributes
- Impact analysis for changes across materials, labels, and batches
Value
Single product truth that flows into development, QA, and manufacturing.
Product Development
From pre-formulation to tech transfer with structured data and decisions.
Key Capabilities
- Formulation versions, DoE tracking, trial/scale-up batches
- Stability studies with pulls, results, and trend charts
- Development reports, risks, and readiness gates
- Digital tech-transfer packages into Production & QA
- Collaboration with R&D, QA, and Regulatory in one workspace
Value
Shorten cycles and reduce late surprises during validation and scale-up.
Product QA
Built-in quality processes with end-to-end traceability.
Key Capabilities
- Deviation/incident logging, investigations, and CAPA
- Change control with risk assessments and approvals
- Complaint handling and market action workflows
- Document control: SOPs, policies, training acknowledgements
- Audit trails, e-signatures, and periodic review reminders
Value
Inspection-ready quality records and faster, cleaner root-cause analysis.
Product Production
Plan, execute, and release with electronic records and equipment linkage.
Key Capabilities
- MPS/MRP planning, batch scheduling, and capacity views
- Master Batch Records (MBR) & Electronic Batch Records (EBR)
- Weigh & dispense with scale integration and label printing
- IPC/QA holds, line clearance, yield & reconciliation
- Equipment logs, calibration/maintenance links, and OEE metrics
Value
Repeatable execution, fewer deviations, and confident batch release.
Cross-Platform Features
- Automations: trigger tasks on status changes (e.g., COA verified → release workflow)
- Analytics: lot aging, batch cycle time, deviation trends, supplier quality
- Integrations: SAP/Oracle/Microsoft ERP, MES/LIMS/QMS/CMMS, DocuSign/Adobe Sign, Okta/Azure AD/Google, GS1/label printers
- Global readiness: multi-site/multi-entity, localization, flexible data residency
Value
Repeatable execution, fewer deviations, and confident batch release.
Security & Compliance
SSO/SCIM, RBAC, field-level permissions, encryption in transit/at rest, immutable audit logs, e-signatures, retention rules, environment options (validation/sandbox). Features support GxP use cases (e.g., 21 CFR Part 11/EU Annex 11-style controls).
Note: Validation status and specific attestations depend on your deployment.
Short Card Blurbs
1.
Warehouse Management
GDP-aligned inventory with lot/expiry, cold chain, and serialization.
2.
Material Management
Specs, COAs, vendor quality, and consumption genealogy—fully traceable.
3.
Product Management
Unified product master, BOMs, labeling, and change history.
4.
Product Development
Formulations, DoE, stability, and tech transfer—ready for scale-up.
5.
Product QA
Deviations, CAPA, change control, complaints, and controlled documents.
6.
Product Production
Plan & execute with MBR/EBR, weigh & dispense, and OEE dashboards.
7.
Pharma365 Platform
Workflows, e-signatures, and integrations that connect R&D to release.
Suggested CTAs & Microcopy
Pricing
Starter
- Core WMS
- Material
- Basic QA workflows
- Standard dashboards
- Email support
Growth
- All Starter
- Product Management
- Development (Dev)
- EBR Light
- Advanced automations
- Connectors
- Priority support
Enterprise
- All Growth
- Full EBR
- Serialization
- Advanced analytics
- Dedicated SSO/SCIM
- Sandbox
- Premium SLA
FAQs
1. Does Pharma365 support GxP and 21 CFR Part 11 needs?
Yes—features include e-signatures, audit trails, versioned documents, and controlled workflows designed to support GxP processes.
2. Can we integrate with our existing ERP/MES/LIMS?
Yes—standard connectors and open APIs for SAP/Oracle/Microsoft ERP, plus MES/LIMS/QMS/CMMS, printers, and scanners.
3. How do you handle validation?
We provide a validation approach and sample documentation; scope depends on your deployment model.
4. Do you support multi-site manufacturers and CMOs?
Yes—multi-entity, site-level controls, and partner access with granular permissions.
5. What about serialization and labeling?
We support GS1 standards, label templates, and printer integrations; country-specific needs can be configured.
