ManOps ERP™
Manufacturing Execution Built for Quality & Compliance
ManOps ERP unifies execution, quality, and traceability for manufacturing operations across industries—from discrete manufacturing to regulated biotech. Configurable workflows, industry-specific modules, and tailored implementations for your manufacturing environment.
What Problem ManOps ERP Solves
Paper batch records and manual logbooks delay batch release and invite audit findings
Lot traceability requires hours of detective work across multiple systems
Deviations and CAPAs live in spreadsheets—no workflow, no audit trail
Equipment calibration tracking is manual; compliance gaps emerge at audit time
Quality events scatter across emails and paper—root cause analysis takes weeks
Multi-plant operations lack governance; each site becomes its own compliance island
What ManOps ERP Is
A manufacturing execution platform that adapts to your industry—discrete, process, regulated, or hybrid manufacturing
ManOps ERP is a modular manufacturing execution platform that scales from discrete manufacturing to highly regulated industries. Unlike rigid legacy systems, ManOps integrates production execution, quality management, asset maintenance, and supply chain in a unified data model with industry-specific configurations.
For Discrete Manufacturing: Job/work order management, real-time OEE tracking, shop floor control, and material traceability.
For Process Manufacturing: Batch/lot tracking, recipe management, material genealogy, and process deviation handling.
For Regulated Industries (Biotech, Pharma, Medical Devices): FDA 21 CFR Part 11 compliance, electronic batch records, CAPA workflows, equipment qualification (IQ/OQ/PQ), and audit-ready documentation.
Whether you operate a single plant or a global network, ManOps ERP provides centralized governance with site-level execution flexibility. Deploy base configurations in 2-4 weeks, or validated systems in 4-8 weeks for regulated environments. Customize workflows, forms, and reports without coding.
The result: A platform that adapts to your manufacturing environment—not the other way around. Fast implementations, flexible configurations, and industry-specific features when you need them.
Industries We Serve
ManOps ERP adapts to your manufacturing environment with industry-specific configurations and workflows
Biotech & Life Sciences
Regulated manufacturing with FDA 21 CFR Part 11 compliance, electronic batch records, lot genealogy, and CAPA workflows
- • Biologics & mAb production
- • Gene & cell therapy
- • Vaccine manufacturing
- • API & small molecules
Discrete Manufacturing
Job/work order management, real-time OEE tracking, quality inspections, and shop floor control
- • Automotive components
- • Electronics assembly
- • Machinery & equipment
- • Aerospace parts
Process Manufacturing
Batch/lot tracking, recipe management, material genealogy, and process control
- • Food & beverage
- • Chemicals & specialty materials
- • Cosmetics & personal care
- • Paints & coatings
Medical Devices
Device history records (DHR), design control, complaint handling, and FDA compliance
- • Implantable devices
- • Diagnostic equipment
- • Surgical instruments
- • In-vitro diagnostics
Need industry-specific features? ManOps includes configurable workflows, custom forms, regulatory templates, and tailored dashboards. Contact us to discuss your manufacturing requirements.
Regulated Manufacturing Features
Industry-leading capabilities for biotech, pharmaceutical, and medical device manufacturing
Built for Regulated Operations
ManOps ERP is designed around 21 CFR Part 11, EU Annex 11, and GMP principles. Electronic signatures, audit trails, and change control are not add-ons—they're the foundation. Every batch record, deviation, and calibration log is timestamped, tamper-proof, and traceable.
→ Deploy with IQ/OQ/PQ documentation included
→ Validation-friendly architecture (no black-box AI)
→ Annual re-validation support built into licensing
Complete Lot & Batch Traceability
Track every material, every batch, every process step—from incoming raw materials through formulation, filling, and packaging. Forward and backward traceability in seconds, not hours. Batch genealogy diagrams auto-generate for investigations.
→ Lot-to-batch-to-unit linkage native to the data model
→ Instant impact analysis for material deviations
→ Recall readiness: identify affected batches in under 60 seconds
Quality & Deviation Management
Deviations, CAPAs, and change controls follow structured workflows with role-based approvals. No more spreadsheets or email threads. Investigations link directly to batch records, equipment logs, and material lots.
→ Deviation trending by product, process, root cause
→ CAPA effectiveness tracking (close the loop, not just the ticket)
→ Out-of-spec (OOS) investigations with automatic data pull
Asset Calibration & Qualification
Equipment calibration schedules, certificates, and usage logs are centralized. Expired calibrations block batch start. Predictive alerts prevent compliance lapses. Equipment qualification (IQ/OQ/PQ) documentation is version-controlled and audit-ready.
→ Automated calibration due-date tracking with escalations
→ Usage logs linked to batch records (which batches used which equipment)
→ Calibration certificates stored with tamper-proof timestamps
Audit-Ready Documentation
When auditors arrive, you don't scramble. Every action has a who/what/when/why audit trail. Reports generate in minutes: batch history records, deviation summaries, CAPA effectiveness, calibration compliance, training records.
→ One-click audit packages (batch records + deviations + materials)
→ Role-based access logs (who accessed what, when)
→ Change control history with approval chains intact
Scalable Governance
Multi-site biotech operations need global process standards with local execution flexibility. ManOps ERP lets you define master batch recipes, SOPs, and quality workflows centrally, then deploy them across sites—while preserving site-specific material suppliers, equipment, and regional compliance requirements.
→ Master data governance (one source of truth for product specs)
→ Site-level overrides for local regulations (e.g., country-specific labeling)
→ Cross-site trending: identify systemic quality issues early
Core Capabilities
Electronic Batch Records (EBR)
- Paperless batch execution with digital signatures
- Master batch records with version control and change management
- Real-time batch status tracking across formulation, filling, packaging
- Batch genealogy: complete forward/backward lot traceability
Quality & Compliance
- Deviation management with structured investigations (5 Why, Fishbone)
- CAPA workflows with effectiveness checks and closure verification
- Out-of-specification (OOS) handling with automatic batch holds
- Audit trails (21 CFR Part 11, EU Annex 11) built into every transaction
Asset & Calibration Management
- Equipment qualification (IQ/OQ/PQ) documentation and lifecycle tracking
- Automated calibration scheduling with compliance blocking (expired = no batch start)
- Predictive maintenance alerts for critical bioprocessing equipment
- Usage logs linked to batch records (equipment-to-batch traceability)
Material & Supply Chain
- Incoming material inspection with COA verification and lot approval
- Vendor qualification and performance tracking (on-time, quality, compliance)
- Lot expiry and retest date management with automatic alerts
- Instant impact analysis: "Which batches used this material lot?"
AI-Driven Insights
- Anomaly detection: flag yield drops, environmental excursions, quality drift
- Predictive analytics for critical quality attributes (CQAs)
- Natural language queries: "Show me all batches with temperature deviations"
- CAPA trending: identify recurring root causes across sites
Real-Time Operational Visibility
- Live batch status dashboard: in-process, pending review, released
- Escalation workflows for deviations, OOS results, calibration failures
- Mobile-first interface for QC inspectors and production supervisors
- Cross-site KPI rollup: compare quality metrics across facilities
Customization & Tailoring Options
ManOps ERP adapts to your unique manufacturing processes, regulatory requirements, and business workflows
Workflow Configuration
- ✓Custom approval routing and escalations
- ✓Configurable state machines for batches, orders, deviations
- ✓Role-based workflows tailored to your org structure
- ✓Event-driven automation and notifications
Forms & Data Capture
- ✓Drag-and-drop form builder (no coding required)
- ✓Custom fields, validation rules, and calculations
- ✓Industry templates (batch records, DHRs, inspection forms)
- ✓Mobile-optimized forms for shop floor data entry
Reporting & Analytics
- ✓Custom dashboards with KPIs specific to your operations
- ✓Ad-hoc report builder with drag-and-drop
- ✓Scheduled reports and automated distribution
- ✓Export to Excel, PDF, CSV, or integrate with BI tools
Integrations
- ✓REST APIs and webhooks for custom integrations
- ✓Pre-built connectors: ERP, LIMS, SCADA, PLCs
- ✓IoT sensor integration for real-time data capture
- ✓Authentication (SSO, LDAP, Active Directory)
Regulatory Compliance
- ✓Pre-validated modules for FDA 21 CFR Part 11
- ✓IQ/OQ/PQ documentation templates included
- ✓Configurable audit trails and electronic signatures
- ✓Annual re-validation support and documentation
Multi-Site Configuration
- ✓Master data governance with site-level overrides
- ✓Regional compliance rules (GDPR, local regulations)
- ✓Cross-site reporting and performance comparison
- ✓Centralized updates with site-specific deployments
Implementation Approach
Core MES/QMS features with out-of-the-box configurations
Tailored workflows, custom forms, integrations, and training
IQ/OQ/PQ documentation, validation testing, regulatory readiness
AI-Driven Intelligence for Regulated Manufacturing
Validation-friendly AI. Explainable. Auditable.
What the AI Does
- •Learns normal operating ranges for critical quality attributes (CQAs) and process parameters
- •Flags anomalies in real-time (temperature excursions, yield drops, environmental deviations)
- •Predicts equipment failures (incubators, chromatography systems, filling lines) before they impact batches
- •Trends CAPA root causes across sites to identify systemic quality issues
Why It Matters for Biotech
- •Catch deviations in-process — not during batch review or worse, at final QC
- •Prevent batch losses — predictive alerts for equipment failures before critical batches are impacted
- •Validation-friendly AI — model logic is explainable, not a black box; auditors can review decision trees
- •Cross-site learning — quality insights from all sites improve operations everywhere
Visual Interface Examples
Batch Genealogy Diagram
Visual lot linkage from raw materials → intermediate → finished product, with deviation flags
Quality Deviation Dashboard
Live deviation status board showing open investigations, CAPA actions, aging analysis
CAPA Trending View
Root cause distribution across sites, product lines, processes—identify systemic issues
Calibration Timeline
Upcoming calibration schedule with expired/due alerts, linked to equipment usage logs
Batch Work-in-Progress View
Real-time batch status across all production lines (formulation, filling, packaging, QC hold, released)
Compliance Summary
Audit-ready metrics: open deviations, overdue CAPAs, expired calibrations, training compliance
Who Should Use ManOps ERP?
Manufacturing Leaders (CMOs, VPs Operations)
Enterprise visibility into batch release cycles, deviation trends, and compliance posture across multiple sites
Pain Points Solved:
Batch delays hidden until too late
Compliance gaps discovered at audit time
Cannot compare site performance on quality metrics
Quality Directors
Structured deviation/CAPA workflows with full traceability, trending, and audit-ready documentation
Pain Points Solved:
Deviations tracked in spreadsheets, no workflow
Root cause analysis takes weeks
No trending to identify systemic issues
Operations & Process Engineers
Real-time batch monitoring, exception alerting, and data for continuous improvement (yield, cycle time, CQAs)
Pain Points Solved:
Manual batch record review delays release
Environmental or process excursions discovered post-batch
No visibility into in-process batch status
Real-World Use Cases
Challenge
Manual batch records and fragmented deviation tracking across cell culture, purification, and fill-finish operations
Solution
Deployed electronic batch records with real-time process monitoring, automated deviation workflows, and complete lot genealogy
Results
- Batch release cycle reduced from 4 weeks to 10 days
- Zero FDA 483 observations in last 2 inspections
- 100% lot traceability from cell bank to vial
Challenge
Compliance gaps in equipment calibration and material traceability for autologous cell therapy batches
Solution
Implemented calibration management with automated blocking (expired calibration = no batch start), plus patient-to-batch linkage for full chain of identity
Results
- Calibration compliance improved to 100%
- Batch genealogy reports generated in <2 minutes for audits
- Chain-of-identity documentation passed regulatory review
Challenge
Deviation backlog and CAPA delays causing audit findings and risk to product supply
Solution
Digitized deviation management with structured investigations (5 Why, Fishbone), automated CAPA workflows, and effectiveness tracking
Results
- Open deviation backlog cleared within 90 days
- Average CAPA closure time reduced from 180 to 45 days
- Audit findings dropped 78% year-over-year
Challenge
Inconsistent quality processes across 5 global sites, making cross-site trending and regulatory harmonization nearly impossible
Solution
Deployed ManOps with centralized master batch records, deviation templates, and compliance dashboards—while preserving site-specific material sourcing and local regulations
Results
- Standardized quality workflows across all 5 sites in 12 weeks
- Cross-site CAPA trending identified 3 systemic issues resolved enterprise-wide
- Single audit-ready compliance view for regulatory inspections
Choose Your Edition
core
per plant/year (base)
Essential manufacturing execution
- Production Planning & Scheduling
- Real-time Shop Floor Monitoring
- Basic Quality Management
- Equipment Tracking (CMMS)
- Standard Reporting & KPIs
- Mobile App Access
pro
per plant/year (base)
Advanced quality + maintenance
- Everything in Core, plus:
- Advanced Analytics & ML Insights
- Supply Chain Integration
- Multi-site Management
- Predictive Maintenance
- Custom Workflows & Automations
- API Access
premium
per plant/year (base)
AI-powered intelligence
- Everything in Pro, plus:
- AI Copilot Integration
- Digital Twin Capabilities
- Enterprise SLA (99.9% uptime)
- Dedicated Support Team
- Custom Integrations
- White-label Options
Pricing Calculator
Estimate your annual ManOps ERP investment
Select modules based on your operational needs. Prices shown per plant/year.
Core Manufacturing Execution
Quality & Compliance
Asset & Maintenance
Materials & Supply Chain
Advanced Features
Custom Development
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Why Customers Choose ManOps
Manufacturing Execution for Biotech: What Sets ManOps Apart
Execution discipline baked in. Batch records aren't forms—they're enforced workflows. Critical steps require verification. Out-of-spec results trigger holds automatically. Expired calibrations block batch start. Compliance isn't a checklist; it's how the system operates.
Quality governance, not quality theater. Deviations follow structured workflows with role-based approvals, root cause investigations, and effectiveness tracking. CAPAs don't just close tickets—they close loops. Trending reveals systemic issues before auditors do.
Audit-ready traceability by default. Lot genealogy is not a reporting add-on—it's the data model. Forward and backward traceability happens in seconds because the linkages (material → batch → unit) are native. Batch history records generate on demand, not after days of manual assembly.
Risk reduction through visibility. Real-time dashboards show what's in-process, what's on hold, what's overdue. Predictive alerts flag issues before they cascade. Multi-site trending identifies quality signals across facilities. You manage risk proactively, not reactively.
Validation without the pain. ManOps ships with IQ/OQ/PQ templates, validation-friendly architecture (no black-box algorithms in critical paths), and annual re-validation support. Deploy a validated system in weeks, not quarters. Validation is part of the product, not a services upsell.
Ready to Build Audit-Ready Manufacturing Operations?
See ManOps in action with a demo tailored to biotech and regulated manufacturing
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