Pharma Manufacturing
Pharmaceutical manufacturers operate in one of the most regulated, precision-driven industries in the world. Whether producing life-saving medications, biologics, or vaccines, companies must meet strict regulatory standards while ensuring quality, safety, and uninterrupted production. With complex equipment, critical facilities, and tight batch integrity requirements, pharma organizations can’t afford unplanned downtime or compliance failures.
The IBM Maximo Application Suite (MAS) offers an integrated asset and maintenance management platform designed to help life sciences organizations optimize equipment reliability, ensure regulatory compliance, and digitize GMP-aligned operations from the shop floor to the cleanroom.
Maximo Application Suite
Manufacturers must adhere to strict GMP, FDA 21 CFR Part 11, EMA, and other global standards, with full auditability.
Electronic Records & Audit Trails
Maintains secure, timestamped records of maintenance, calibration, and validation.
Validation-Ready Platform
Supports FDA and EMA-compliant workflows with traceability and electronic signatures.
Inspection Scheduling
Automates recurring regulatory checks and tracks deviations, CAPAs, and outcomes.
Downtime of key assets like reactors, centrifuges, HVAC, or water systems halts batch production and affects product quality.
Predictive Maintenance (Maximo Predict)
Uses AI and sensor data to forecast failures and proactively schedule repairs.
Asset Condition Monitoring (Maximo Monitor)
Continuously tracks performance metrics of GMP-critical equipment.
Spare Parts Forecasting
Ensures availability of parts to prevent extended outages during scheduled or unplanned maintenance.
Instruments used in production and lab settings must be calibrated and validated at strict intervals — with full documentation.
Calibration Scheduling
Automates recurring calibration tasks, logs results, and links them to asset records.
Integrated SOPs & Validation Logs
Embeds procedures directly into work orders and ensures compliance with protocol steps.
Audit-Ready Records
Captures calibration tolerances, equipment status, and out-of-spec events for regulatory reviews.
Managing high-value lab and production assets with a long lifecycle and critical part dependencies is complex and cost-sensitive.
Lifecycle Costing
Tracks total cost of ownership and usage history to inform asset replacement or upgrades.
Spare Parts Optimization
Forecasts inventory needs and aligns procurement with planned shutdowns and validations.
Inventory Serialization & Lot Control
Ensures traceability of parts used on validated equipment.
Cleanrooms must maintain controlled temperature, humidity, and particle counts, and equipment must comply with sterility protocols.
BMS & IoT Integration
Interfaces with building automation systems to monitor cleanroom conditions and trigger alerts.
Controlled Asset Scheduling
Enables special workflows and PPE protocols for assets in sterile environments.
Environmental Monitoring Dashboards
Provides visibility into HVAC, filtration, and environmental control system health.
Environmental Monitoring Dashboards: Provides visibility into HVAC, filtration, and environmental control system health.
SOP Embedding in Work Orders
Technicians must review and follow SOPs before signing off on work, ensuring procedural compliance.
Digital Signatures & Checklists
Enforces step-by-step task validation with timestamped records and technician certification checks.
Version Control & Audit Trails
Ensures the latest SOP versions are applied across all operations.
Global pharmaceutical operations require consistent processes and asset management across manufacturing sites.
Multi-Site Configuration
Allows each plant or facility to operate independently under a common corporate standard.
Global Templates & SOP Libraries
Standardizes procedures while allowing local customization based on region or product.
Cloud & On-Premise Flexibility
Supports highly regulated environments with ITAR- or GxP-compliant deployment options.
Pharma operations consume significant energy and water — creating pressure to meet sustainability and ESG targets.
Energy Consumption Tracking
Monitors energy usage by equipment, facility, and process stage.
Environmental Compliance Dashboards
Tracks waste output, chemical usage, and carbon emissions.
Optimization of Energy-Intensive Equipment
Identifies overperforming HVAC or refrigeration systems to reduce energy waste.
Add value to your operations with Maximo Application Suite
Scalability
Supports growth and integration of new technologies like IoT and AI.
Centralized Operations
Unifies asset data, maintenance workflows, and performance monitoring.
Cost Savings
Reduces operational costs through optimized asset utilization and energy efficiency.
Strategic Decision-Making
Provides actionable insights to support investment and planning.
Explore how Maximo’s cutting-edge technology can revolutionize your approach to asset management, maintenance, and regulatory compliance.
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