Our Services

Accurate, audit-ready documentation is the foundation of pharmaceutical compliance. Our consultants specialize in creating, revising, and converting SOPs, batch records, equipment manuals, and system specification documents to meet current GMP standards and support quality system upgrades or facility acquisitions.

• SOP creation and revision
• Batch record review and updates
• System Specification Documents
• Equipment Manual revisions
• Quality system template conversions

We support the full validation lifecycle — from IQ/OQ/PQ protocols through execution, summary reports, and deviation management. Our team has deep experience in equipment, process, and computer system validation within FDA-regulated environments.

• IQ / OQ / PQ protocol authoring
• Validation execution and reporting
• Computer System Validation (CSV)
• Process validation support
• Deviation and CAPA management

Ensuring controlled storage environments meet regulatory requirements is critical for product integrity. Amris provides comprehensive temperature mapping studies for warehouses, cold rooms, refrigerators, freezers, and incubators — with full documentation packages.

• Warehouse and cold room mapping
• Refrigerator and freezer qualification
• Incubator and oven mapping
• Sensor placement and calibration
• Full mapping report packages

We analyze and document your manufacturing and quality processes to identify inefficiencies, compliance gaps, and improvement opportunities. Using Six Sigma and LEAN methodologies, we help you streamline operations without compromising regulatory standing.

• Current-state process mapping
• Gap analysis and improvement planning
• Six Sigma / LEAN methodology
• Workflow optimization
• Change control documentation

When quality events occur, rapid and thorough investigation is essential. Our consultants apply structured Root Cause Analysis and Systematic Problem Solving frameworks to identify true root causes, develop effective CAPAs, and prevent recurrence.

• Fishbone / Ishikawa analysis
• 5-Why methodology
• CAPA development and tracking
• Deviation investigation support
• Trend analysis and reporting

Our automation specialists bring over a decade of experience in PLC design, BMS integration, and HVAC control systems. We support system design, installation, commissioning, and ongoing service across all major platforms — Rockwell, Siemens, ABB, and more.

• PLC system design and installation
• Building Management Systems (BMS)
• HVAC and lighting control
• Energy efficiency optimization
• Rockwell, Siemens, ABB, Direct Logics

Amris professionals have managed pharmaceutical capital projects valued in excess of $1 million. We provide end-to-end project management from conceptual design through commissioning and handover, keeping your projects on schedule, on budget, and inspection-ready.

• Capital project management
• Conceptual design through handover
• CMMS development and implementation
• Cross-functional team leadership
• Schedule and budget management

Maintaining calibrated instruments is a core GMP requirement. Our team develops and implements calibration programs, manages calibration schedules, and ensures your instruments are qualified, documented, and compliant with regulatory expectations.

• Calibration program development
• Instrument qualification
• Calibration schedule management
• Out-of-tolerance investigations
• Calibration SOP authoring