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® WMS fruiSCE® MES fruiSCE® ERP Integrations & Compliance

fruiSCE Warehouse Management System For Pharma

Core Warehouse & Inventory Control

GxP-Compliant Warehouse with Re-test & Expiry Management

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Dynamic Quarantine: Automated sampling trigger with quarantine reason codes.
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Re-test Alerts: Automatic 30/60/90 day notifications before re-test.
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Expiry Enforcement: Prevents expired material movement automatically.
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Cold Chain Stability: Real-time temperature and humidity monitoring with alerts.
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FEFO Management: Prioritizes first-expiry-first-out inventory automatically.
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CSV Ready: Pre-built IQ/OQ scripts and traceability matrix support.

Sampling Plans, LIMS Integration & Returned Goods

Intelligent Sampling, Quality Integration & Returned Material Control

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Dynamic Sampling Plans: Supports ANSI/ASQ Z1.4, ISO 2859 and client-defined sampling logic.
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Sample Tracking: Barcode-based sample containers with complete chain of custody logs.
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LIMS Integration: Bi-directional sync between WMS and LIMS for automated status updates.
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Returned Goods Workflow: Separate quarantine with QA approval and stability review process.
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Rejected Material Zone: Restricted access control with monitored destruction workflows.

Part 11 Compliant Audit Trail & Dual Witness

Secure Electronic Signatures & Regulatory Audit Compliance

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Electronic Signatures: Biometric and card-based approvals with complete signature manifestation.
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Dual Witness Mode: Sequential operator approvals for high-risk warehouse transactions.
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Audit Trail: Captures all CRUD activities with tamper-proof event history.
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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

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Master Recipe Management: Version-controlled recipes with e-signature activation and change control linkage.
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EBR Execution: Barcode-based material verification with equipment state validation.
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HPAPI Dispensing: Closed-transfer dispensing with reconciliation tolerance enforcement.
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Double Verification: Mandatory second-operator confirmation for critical weight variations.
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Deviation Management: In-line deviation capture with automated QA notification workflow.

Equipment State Tracking & Sterile Component Management

Cleaning Validation & Sterile Production Readiness

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Equipment State Machine: Tracks equipment lifecycle from cleaned to maintenance-required states.
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Cleaning Validation: Prevents batch execution outside validated cleaning hold time.
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Cleaning Labels: Automated label printing with operator and detergent traceability.
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Sterile Kitting: Virtual component assembly with sterilization cycle traceability.
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Utensil Management: Tracks sterilization expiry and usage count for each utensil.

Real-Time Cleanroom Environmental Monitoring

Live Environmental Compliance Monitoring for Manufacturing

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Live EM Feed: Displays particles, viable counts, humidity and pressure directly on MES.
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Action Limit Alerts: Automatically pauses batches when EM exceeds configured limits.
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Batch Release Block: QA release restricted until investigation and impact assessment complete.
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EM Archive: Stores environmental records for 10+ years with advanced retrieval support.

Preliminary & Final Electronic Batch Records

Controlled Draft Records & Final QA Approved EBRs

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Preliminary EBR: Draft production records generated with “NOT FOR RELEASE” watermark.
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Final EBR Generation: Generated only after QA approval and deviation closure completion.
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Digital Signatures: Time-stamped and tamper-evident electronic approval workflow.
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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

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Material Master GxP Fields: Tracks sterility, storage conditions, HPAPI flags, shelf life and validation requirements.
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Production Planning: Campaign-based planning with allergen segregation and cleaning validation holds.
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Change Control Module: System changes trigger automated impact assessment and approval workflows.
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Re-validation Scheduler: Automatically schedules IQ/OQ activities based on change classification.
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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

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Attributable: Every action linked to a unique user ID with no shared accounts.
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Contemporaneous: Secure timestamps generated directly from protected system clocks.
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Accurate & Complete: Validation rules and metadata retention ensure trusted data integrity.
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Enduring Storage: Records archived in WORM storage for long-term compliance retention.
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User Access Control: Role-based LDAP/SSO access with periodic review and e-signature approval.
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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)

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Risk Assessment: Pre-filled templates covering patient safety, product quality and regulatory impact.
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Validation Plan: Tailored for 21 CFR Part 11, EU Annex 11, GAMP5 and PIC/S PI 041.
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URS / FS / DS Specifications: Pre-written libraries for WMS, MES and ERP including HPAPI and EM workflows.
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IQ / OQ / PQ Scripts: Ready-to-execute validation scripts with expected and negative testing scenarios.
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Traceability Matrix: Automatically maps requirements to validation and testing evidence.
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Validation Report: Includes deviations, residual risk assessment and QA sign-off summaries.
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Periodic Review: Automated audit trail review scripts for annual and event-based assessments.
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Review by Exception (RBE): Only exception batches require detailed QA review while clean batches auto-certify.
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Audit Trail Analysis: Detects suspicious activities including after-hours access, backdating and deletions.
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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

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Non-Conformance (NC): Automatically generated from MES deviations, EM excursions and OOS events.
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CAPA Management: Integrated root cause analysis with mandatory effectiveness verification before closure.
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Change Control: Fully traceable workflow from request through approval, implementation and re-validation.
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Supplier Management: Supplier audit status linked directly with WMS material receipt workflows.
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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

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Aggregation / Disaggregation: Tracks serialized products across manufacturing, warehousing and distribution stages.
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WMS & ERP Integration: Validates shipment serial numbers directly against national verification repositories.
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Return Verification: Confirms serial authenticity before accepting returned pharmaceutical products.
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Compliance Reporting: Generates suspicious product alerts and automated verification response reports.
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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

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Live EM Monitoring: Real-time environmental monitoring data displayed directly on MES batch records.
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Equipment State Machine: Tracks equipment lifecycle with validated cleaning hold-time enforcement.
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Sterilization Tracking: Complete autoclave cycle tracking with parameter and sterilization status history.
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Garment Management: Tracks cleanroom garment sterilization count, expiry and usage lifecycle.
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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

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Automated Sampling Plans: Sampling workflows triggered automatically during material receipt processing.
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Sample Container Barcoding: Barcode-enabled sample tracking with full chain-of-custody visibility.
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LIMS Integration: Laboratory results automatically update material status directly within WMS.
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COA Management: Certificate of Analysis attached at lot level for dispensing verification in MES.
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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

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Dispensing Reconciliation: Supports ±0.5% tolerance enforcement for highly potent compounds with strict OEL limits.
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Containment Verification: Integrates with continuous monitoring systems and external particle counters.
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Dual Operator Witness: Mandatory sequential operator verification for all HPAPI dispensing transactions.
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Decontamination Workflow: Cleaning verification required before equipment maintenance activities begin.
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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

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After-hours Transactions: Detects system activities performed between 10 PM and 6 AM automatically.
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User Sharing Risk: Flags suspicious logins from multiple IP addresses using the same user ID.
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Backdating Attempts: Identifies timestamps older than previous system-generated records.
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Mass Deletions: Detects unusual deletion patterns exceeding defined record thresholds.
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Workflow Violations: Flags material release activities performed without required COA attachment.
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Signature Timing Analysis: Monitors mismatches between e-signature and operational timestamps.
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Monthly Management Report: Generates summarized risk ratings, flagged events and corrective actions.
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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.

Regulatory Ready

✓ 21 CFR Part 11 Compliance
✓ EU Annex 11 Ready
✓ GAMP5 Category 4 & 5
✓ ALCOA+ Data Integrity
✓ HPAPI & Cleanroom Support
✓ Automated Audit Trail Review