CAPS

AmpleLogic CAPS (Calibration & Preventive Maintenance System) is a GMP-focused asset intelligence platform designed for life sciences and regulated manufacturing environments. It combines calibration management, preventive maintenance automation, and AI-driven predictive analytics to monitor equipment health, automate scheduling, and maintain continuous regulatory compliance. The platform is intended for pharmaceutical, biotechnology, medical device, CRO/CDMO, and broader life sciences organizations that need to move beyond paper-based or basic digital maintenance tracking.

Rather than simply recording calibration and maintenance activities, CAPS continuously analyzes equipment performance data, identifies potential failure patterns early, and supports proactive decision-making. The system is built to address common pain points in GMP environments, including manual tracking errors, audit readiness gaps, missed calibrations, and lack of real-time equipment visibility.

Core Features and Capabilities

• Job Order Management: Create, assign, and track work orders for both scheduled and unscheduled maintenance tasks, including clearance workflows and engineering acknowledgement steps.
• Preventive Maintenance Automation: Auto-generates maintenance and calibration tasks based on configured frequencies, reducing the risk of missed activities.
• Maintenance Planning: Supports structured planning of maintenance activities across equipment and instrument inventories.
• Centralized Dashboards: Real-time dashboards provide visibility into equipment health, compliance status, and key performance indicators for management and technicians.
• RFID & Barcode Tracking: Supports asset identification and tracking using RFID and barcode technologies.
• AI-Driven Predictive Maintenance: Built-in AI agents evaluate equipment performance trends, predict failure patterns, and recommend optimal maintenance schedules before failures occur.
• Digital Checklists & Guided Execution: Configurable, mobile-ready checklists guide technicians through each maintenance step, reducing errors and omissions.
• Automated Deviation and CAPA Triggers: When tolerance periods for acknowledgement or execution are exceeded, the system automatically triggers deviation and CAPA workflows.
• Audit-Ready Documentation: Complete digital records with timestamps, electronic signatures, and full traceability are maintained for every maintenance activity.

End-to-End Workflow

1. Master Data: Define equipment, instruments, and maintenance parameters in a central registry.
2. Equipment and Instrument Registration: Register all assets and link them with maintenance frequencies and checkpoints.
3. Task Generation Based on Frequency: The system automatically generates calibration and maintenance tasks according to configured schedules.
4. Raise Job Order: Create and dispatch scheduled or unscheduled job orders with associated clearance workflows.
5. Engineering Acknowledgement: Engineers acknowledge tasks and route them to internal checkpoints or external service attachments.
6. Execution and Confirmation: Technicians execute checkpoints, attach supporting documentation, and confirm completion using digital signatures. If tolerance periods are exceeded at any stage, the system automatically triggers a deviation.

Compliance Framework

• Supports 21 CFR Part 11 compliance through built-in digital signatures and audit trails.
• Aligns with WHO and EU GMP Guidelines for equipment calibration, maintenance, and qualification.
• Provides calibration tolerance checks and pass/fail decision tracking that are 21 CFR compliant.
• Includes formal, workflow-driven calibration processes with GMP audit trails, replacing loosely controlled or manual verification approaches.
• Implementation includes pre-configured GMP modules, validated templates, and GAMP 5-aligned documentation.

Business and Compliance Benefits

• Reduces unplanned downtime by 45% through automated scheduling and real-time equipment monitoring.
• Cuts emergency maintenance costs by 60% through preventive scheduling and AI-powered predictive maintenance.
• Achieves 70% faster approval workflows via digital signatures, automated routing, and elimination of paper-based bottlenecks.
• Delivers a reported 3–5x return on investment through reduced emergency repairs, minimized downtime, and extended equipment lifespan.
• Minimizes regulatory risk and audit observations through proactive compliance monitoring.
• Accelerates batch release speed by reducing unplanned production stoppages.
• Increases technician efficiency through mobile-ready interfaces and guided task workflows.
• Reduces administrative labor costs by automating approval workflows and documentation tasks.

Enterprise Integrations

• DMS (Document Management System): Automates archival of calibration certificates and logs; ensures the latest SOPs are always accessible.
• LMS (Learning Management System): Verifies technician training and certification status before allowing task execution.
• eQMS (Electronic Quality Management System): Automatically triggers Deviation and CAPA workflows for failures and missed preventive maintenance events.
• LIMS (Laboratory Information Management System): Blocks instrument use when calibration status is "Expired" or "Failed," protecting data integrity.
• eBMR / MES: Synchronizes equipment status to ensure only validated equipment is used in manufacturing.
• SAP / ERP: Bi-directional synchronization of equipment master data, cost centers, and maintenance history.
• UMS (User Management System): Unified user management with single sign-on and access provisioning across maintenance modules.

Industries Supported

• Pharmaceuticals: GMP-compliant calibration and preventive maintenance for manufacturing environments.
• Biotechnology: Precision instrument management for biotech laboratories.
• Medical Devices: ISO 13485-aligned equipment qualification.
• CRO / CDMO: Multi-client equipment segregation and audit trail management.
• Life Sciences: Enterprise-wide maintenance governance across multiple sites.
• Manufacturing: Preventive maintenance for production equipment in regulated settings.

CAPS is deployed as part of AmpleLogic's aPaaS ecosystem, enabling native integration with eQMS, LIMS, eBMR, DMS, LMS, SAP/ERP, and UMS for end-to-end equipment lifecycle enforcement. The platform has been adopted by customers including Laurus Labs, which used CAPS to digitize manual paper-based calibration processes and achieve full GMP compliance. The system is rated 4.9 out of 5 on G2 based on 21 or more reviews.