fruiSCE Pharma Suite – GAMP5 Validated CSV-Ready for WMS, MES & ERP
Pre-validated, risk-based CSV approach with 21 CFR Part 11, EU Annex 11, and ALCOA+ compliance. Includes environmental monitoring, cleaning validation, audit trail review, and HPAPI safety
✓ FDA 21 CFR Part 11 Ready
✓ EU Annex 11 Compliant
✓ GAMP5 Category 4 & 5
✓ ALCOA+ by Design
fruiSCE Warehouse Management System For Pharma
Core Warehouse & Inventory Control
GxP-Compliant Warehouse with Re-test & Expiry Management
✓
Dynamic Quarantine:
Automated sampling trigger with quarantine reason codes.
✓
Re-test Alerts:
Automatic 30/60/90 day notifications before re-test.
✓
Expiry Enforcement:
Prevents expired material movement automatically.
✓
Cold Chain Stability:
Real-time temperature and humidity monitoring with alerts.
✓
FEFO Management:
Prioritizes first-expiry-first-out inventory automatically.
✓
CSV Ready:
Pre-built IQ/OQ scripts and traceability matrix support.
Sampling Plans, LIMS Integration & Returned Goods
Intelligent Sampling, Quality Integration & Returned Material Control
✓
Dynamic Sampling Plans:
Supports ANSI/ASQ Z1.4, ISO 2859 and client-defined sampling logic.
✓
Sample Tracking:
Barcode-based sample containers with complete chain of custody logs.
✓
LIMS Integration:
Bi-directional sync between WMS and LIMS for automated status updates.
✓
Returned Goods Workflow:
Separate quarantine with QA approval and stability review process.
✓
Rejected Material Zone:
Restricted access control with monitored destruction workflows.
Part 11 Compliant Audit Trail & Dual Witness
Secure Electronic Signatures & Regulatory Audit Compliance
✓
Electronic Signatures:
Biometric and card-based approvals with complete signature manifestation.
✓
Dual Witness Mode:
Sequential operator approvals for high-risk warehouse transactions.
✓
Audit Trail:
Captures all CRUD activities with tamper-proof event history.
✓
Periodic Review:
Flags suspicious warehouse activities and compliance exceptions automatically.
fruiSCE Manufacturing Execution System (MES) For Pharma
Electronic Batch Records (EBR) with HPAPI & Dispensing Controls
Controlled Batch Manufacturing with Dispensing Validation
✓
Master Recipe Management:
Version-controlled recipes with e-signature activation and change control linkage.
✓
EBR Execution:
Barcode-based material verification with equipment state validation.
✓
HPAPI Dispensing:
Closed-transfer dispensing with reconciliation tolerance enforcement.
✓
Double Verification:
Mandatory second-operator confirmation for critical weight variations.
✓
Deviation Management:
In-line deviation capture with automated QA notification workflow.
Equipment State Tracking & Sterile Component Management
Cleaning Validation & Sterile Production Readiness
✓
Equipment State Machine:
Tracks equipment lifecycle from cleaned to maintenance-required states.
✓
Cleaning Validation:
Prevents batch execution outside validated cleaning hold time.
✓
Cleaning Labels:
Automated label printing with operator and detergent traceability.
✓
Sterile Kitting:
Virtual component assembly with sterilization cycle traceability.
✓
Utensil Management:
Tracks sterilization expiry and usage count for each utensil.
Real-Time Cleanroom Environmental Monitoring
Live Environmental Compliance Monitoring for Manufacturing
✓
Live EM Feed:
Displays particles, viable counts, humidity and pressure directly on MES.
✓
Action Limit Alerts:
Automatically pauses batches when EM exceeds configured limits.
✓
Batch Release Block:
QA release restricted until investigation and impact assessment complete.
✓
EM Archive:
Stores environmental records for 10+ years with advanced retrieval support.
Preliminary & Final Electronic Batch Records
Controlled Draft Records & Final QA Approved EBRs
✓
Preliminary EBR:
Draft production records generated with “NOT FOR RELEASE” watermark.
✓
Final EBR Generation:
Generated only after QA approval and deviation closure completion.
✓
Digital Signatures:
Time-stamped and tamper-evident electronic approval workflow.
✓
Complete Raw Data:
Includes weights, parameters, EM data and complete execution history.
fruiSCE ERP For Pharma
Pharma-Ready ERP with Change-Controlled Configuration
GxP-Compliant Supply Chain, Financials & Change Management
✓
Material Master GxP Fields:
Tracks sterility, storage conditions, HPAPI flags, shelf life and validation
requirements.
✓
Production Planning:
Campaign-based planning with allergen segregation and cleaning validation holds.
✓
Change Control Module:
System changes trigger automated impact assessment and approval workflows.
✓
Re-validation Scheduler:
Automatically schedules IQ/OQ activities based on change classification.
✓
OOS / OOT Management:
Integrates with LIMS and blocks affected materials from production planning.
ALCOA+ Compliance Across All Modules
Data Integrity by Design for Regulatory Compliance
✓
Attributable:
Every action linked to a unique user ID with no shared accounts.
✓
Contemporaneous:
Secure timestamps generated directly from protected system clocks.
✓
Accurate & Complete:
Validation rules and metadata retention ensure trusted data integrity.
✓
Enduring Storage:
Records archived in WORM storage for long-term compliance retention.
✓
User Access Control:
Role-based LDAP/SSO access with periodic review and e-signature approval.
✓
CSV Validation Package:
Includes predefined ERP validation test cases for audits and compliance.
CSV Accelerator For Pharma
GAMP5 Category 4 & 5 – Reduce Validation Time from 9 Months to 4 Months
Includes Automated Audit Trail Review & Review by Exception (RBE)
✓
Risk Assessment:
Pre-filled templates covering patient safety, product quality and regulatory impact.
✓
Validation Plan:
Tailored for 21 CFR Part 11, EU Annex 11, GAMP5 and PIC/S PI 041.
✓
URS / FS / DS Specifications:
Pre-written libraries for WMS, MES and ERP including HPAPI and EM workflows.
✓
IQ / OQ / PQ Scripts:
Ready-to-execute validation scripts with expected and negative testing scenarios.
✓
Traceability Matrix:
Automatically maps requirements to validation and testing evidence.
✓
Validation Report:
Includes deviations, residual risk assessment and QA sign-off summaries.
✓
Periodic Review:
Automated audit trail review scripts for annual and event-based assessments.
✓
Review by Exception (RBE):
Only exception batches require detailed QA review while clean batches auto-certify.
✓
Audit Trail Analysis:
Detects suspicious activities including after-hours access, backdating and
deletions.
✓
Validation State Tracking:
Real-time dashboards for validation progress, deviations and change control impact.
Quality Management System (QMS) Integration
Unified QMS – Non-Conformance, CAPA & Change Control
End-to-End Quality Management with Full Regulatory Traceability
✓
Non-Conformance (NC):
Automatically generated from MES deviations, EM excursions and OOS events.
✓
CAPA Management:
Integrated root cause analysis with mandatory effectiveness verification before
closure.
✓
Change Control:
Fully traceable workflow from request through approval, implementation and
re-validation.
✓
Supplier Management:
Supplier audit status linked directly with WMS material receipt workflows.
✓
Audit Compliance:
Receipt transactions automatically blocked when supplier audits become overdue.
Serialization,Track & Trace
DSCSA / EU FMD / Global Serialization
End-to-End Pharmaceutical Serialization & Supply Chain Traceability
✓
Aggregation / Disaggregation:
Tracks serialized products across manufacturing, warehousing and distribution
stages.
✓
WMS & ERP Integration:
Validates shipment serial numbers directly against national verification
repositories.
✓
Return Verification:
Confirms serial authenticity before accepting returned pharmaceutical products.
✓
Compliance Reporting:
Generates suspicious product alerts and automated verification response reports.
✓
Global Traceability:
Supports DSCSA, EU FMD and other global pharmaceutical serialization standards.
Environmental Monitoring & Equipment Integration
Real-Time Cleanroom Data + Equipment State + Cleaning Validation
Unified Monitoring & Validation Visibility for QA and Engineering Teams
✓
Live EM Monitoring:
Real-time environmental monitoring data displayed directly on MES batch records.
✓
Equipment State Machine:
Tracks equipment lifecycle with validated cleaning hold-time enforcement.
✓
Sterilization Tracking:
Complete autoclave cycle tracking with parameter and sterilization status history.
✓
Garment Management:
Tracks cleanroom garment sterilization count, expiry and usage lifecycle.
✓
QA / Engineering Summary View:
Centralized quick-reference dashboard for monitoring, validation and compliance
review.
Sampling, LIMS & QC Integration
From Receipt Sampling to COA and Material Release
End-to-End Sampling, Laboratory Integration & Quality Control Visibility
✓
Automated Sampling Plans:
Sampling workflows triggered automatically during material receipt processing.
✓
Sample Container Barcoding:
Barcode-enabled sample tracking with full chain-of-custody visibility.
✓
LIMS Integration:
Laboratory results automatically update material status directly within WMS.
✓
COA Management:
Certificate of Analysis attached at lot level for dispensing verification in MES.
✓
Material Release Control:
Only approved and released materials become available for manufacturing operations.
HPAPI & Potent Compound Safety
High Potency API (HPAPI) Controls
Advanced Safety, Containment & Compliance for Potent Compound Handling
✓
Dispensing Reconciliation:
Supports ±0.5% tolerance enforcement for highly potent compounds with strict OEL
limits.
✓
Containment Verification:
Integrates with continuous monitoring systems and external particle counters.
✓
Dual Operator Witness:
Mandatory sequential operator verification for all HPAPI dispensing transactions.
✓
Decontamination Workflow:
Cleaning verification required before equipment maintenance activities begin.
✓
Waste Tracking:
Tracks contaminated waste containers with destruction certificate documentation.
Audit Trail Review & Data Integrity Dashboard
Automated Audit Trail Review – Inspection Ready
Intelligent Monitoring & Data Integrity Risk Detection Across All Systems
✓
After-hours Transactions:
Detects system activities performed between 10 PM and 6 AM automatically.
✓
User Sharing Risk:
Flags suspicious logins from multiple IP addresses using the same user ID.
✓
Backdating Attempts:
Identifies timestamps older than previous system-generated records.
✓
Mass Deletions:
Detects unusual deletion patterns exceeding defined record thresholds.
✓
Workflow Violations:
Flags material release activities performed without required COA attachment.
✓
Signature Timing Analysis:
Monitors mismatches between e-signature and operational timestamps.
✓
Monthly Management Report:
Generates summarized risk ratings, flagged events and corrective actions.
✓
Batch Review Certificate:
Provides QA-approved audit trail review certification for every production batch.
Ready for your next FDA / EMA / MHRA inspection?
fruiSCE pre-validated suite includes environmental monitoring, cleaning validation, HPAPI controls, audit trail review, serialization, LIMS integration and complete CSV documentation. Successfully deployed in regulated GxP environments globally.
Schedule Pharma DemoRegulatory Ready
✓ 21 CFR Part 11 Compliance
✓ EU Annex 11 Ready
✓ GAMP5 Category 4 & 5
✓ ALCOA+ Data Integrity
✓ HPAPI & Cleanroom Support
✓ Automated Audit Trail Review
Accomplish a successful Supply Chain transformation through fruiSCE, World-class Supply Chain operations.
- Data Labs India Solutions pvt ltd.
- Office 201, Plot No. 28-7-154, APHB Colony, Anantapur-515001, AP, INDIA
- Phone: +91 7799798333
- E-Mail: [email protected]
Product
- Business Networks
- Enterprise Resource Planning
- Manufacturing Execution
- Warehouse Management
- Control Tower
- Fleet Management
- Transport Management
- Demand Planning
- Global Trade Management
- Supplier Connect Manufacturing
- Manufacturing Execution Syetem
- Job Shop Manufacturing
- Discrete Assembly Manufacturing
- Process & Batch Manufacturing
- Integrations Warehousing
- Warehouse Management System
- WMS 3PL 4PL
- Yard Management System
- WMS Manufacturing Units
- Distribution Centers & Cold Storage Logistics
- Fleet Management System (FMS)
- Global Trade Management
- TMS for 3PL and 4PL
- GPS & Integrations Planning & Optimization
- Demand Planning
- Supply Chain Optimization ERP & Business Network
- Enterprise Resource Planning
- Business Networks
- Control Tower