POMSnet Aquila

Key characteristics and capabilities of POMSnet Aquila include:

1. Modern Web-Based HTML5 Interface:

   • Accessible across standard web browsers, mobile tablets, and touch-screen operator terminals across cleanroom and shop-floor environments.

2. Electronic Batch Records (EBR):

   • Enables complete paperless manufacturing, computer-guided recipe execution, real-time data capture, and complete electronic audit trails.

3. Configurable Out-of-the-Box (No Custom Code):

   • Delivers standard, pre-validated life sciences best practices with 100+ S88 phases, enabling fast deployment and continuous upgradability.

4. Review-by-Exception & Release-by-Exception:

   • Dramatically cuts quality review cycles by isolating batch deviations, with automated batch release capabilities for zero-exception production runs.

5. Biometric Authentication Readiness:

   • Natively integrates with wearable biometric devices (such as the Nymi Band) to provide touchless, on-body biometric authentication and FDA 21 CFR Part 11 compliant e-signatures.

6. Worksheets & Digital Log Books:

   • Supports scheduled maintenance, cleaning, equipment readiness checks, ad hoc tasks, and planned deviations without generating a final product batch.

7. Comprehensive Regulatory Compliance:

   • Engineered to satisfy stringent global regulatory frameworks including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and cGMP data integrity standards.

8. Flexible On-Premises or Cloud SaaS Deployment:

   • Available as an on-premise installation or a fully validated, private cloud-hosted SaaS deployment through life sciences compliance partner Validated Cloud.

POMSnet Aquila delivers complete manufacturing execution functionality out of the box in a single unified install:

1. Order Management:

   • Provides complete control over work orders and batches (create, release, hold, resume, split, close, or delete) with full hierarchical execution tracking.

2. Equipment Management:

   • Centralizes oversight of rooms, assets, calibration, and cleaning statuses with barcode verification and automated allocation rules.

3. Material Management:

   • Controls raw materials, intermediates, and finished goods with real-time tracking at both lot and container levels, including waste reporting and inventory reconciliation.

4. Specification & Recipe Authoring:

   • Graphical interface for authoring ISA-S88 standard recipes with version control, effectivity dates, and extensive reusable phase libraries.

5. Weigh and Dispense:

   • Supports central and cleanroom dispensing with 15+ standard methods (batch weighing, campaign weighing, tolerance checking, and scale integration).

6. Quality Management & Disposition:

   • Automates 21 CFR Part 11 electronic records, electronic signatures, FIFO/FEFO rules, expiry tracking, retesting workflows, and lot dispositioning.

7. Personnel Management:

   • Validates operator qualifications, training credentials, SOP readiness, and system access rights prior to initiating manufacturing steps.

8. cGMP Reports & Dashboards:

   • Over 50 standard out-of-the-box cGMP audit and release reports (Execution, Review, Summary, Full EBR) alongside open SQL analytics support.

POMSnet Aquila MES bridges shop-floor operations with enterprise business layers across the ISA-95 hierarchy:

1. ISA-95 Level 4 (Business Logistics & ERP):

   • Built-in ERPi module connects to enterprise ERP systems (such as SAP and Oracle) using Service-Oriented Architecture (SOA), supporting Web Services, JMS, MQ-Series, MSMQ, and database interfaces.

2. ISA-95 Level 3 (Manufacturing Operations & Control):

   • Seamless data exchange with Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS), CAPA, Warehouse Management Systems (WMS), and Maintenance Systems (CMMS).

3. ISA-95 Level 2 (Process Control Systems & Automation):

   • Standard L2 Transaction Interface and OPC connectivity allow direct bidirectional integration with DCS, SCADA, and PLC control systems for S88 automated batch execution and parameter collection.

4. ISA-95 Level 1 (Shop Floor Devices & Instrumentation):

   • Direct communication with physical workstations, precision weigh scales, barcode readers, thermal printers, and biometric authentication devices.

Before beginning training in POMSnet Aquila MES, the following foundational skills and knowledge are recommended:

1. Life Sciences & GMP Basics:

   • Understanding of pharmaceutical, biotechnology, or medical device manufacturing fundamentals, along with Good Manufacturing Practice (cGMP) regulations.

2. Manufacturing Workflow Concepts:

   • Familiarity with standard batch manufacturing lifecycle steps, such as material dispensing, compounding, filling, packaging, and batch record review.

3. Basic IT and Web System Proficiency:

   • General comfort navigating web-based enterprise applications, standard Windows environments, and relational database concepts.

4. Awareness of Enterprise Systems:

   • A high-level understanding of related enterprise platforms such as ERP (e.g., SAP), LIMS, or plant automation systems is helpful for integration topics.

Our course guides participants through core MES concepts, master recipe configuration, and compliance workflows step-by-step.

Mastering POMSnet Aquila provides you with high-demand expertise in life sciences digital manufacturing and MES engineering:

1. Paperless Manufacturing & EBR Execution:

   • Expertise in configuring, running, and managing Electronic Batch Records (EBR) and digital logbooks for pharmaceutical and biotech plants.

2. S88 Recipe & Specification Authoring:

   • Ability to design, validate, and manage S88-compliant master recipes, operations, and reusable execution phases.

3. Weigh & Dispense Configuration:

   • Hands-on skills to establish central and line dispensing methods, scale integrations, tare/gross checks, and container-level tracking.

4. Review-by-Exception & Compliance Management:

   • Proficiency in conducting exception-based batch reviews, managing electronic signatures, and enforcing FDA 21 CFR Part 11 / EU Annex 11 compliance.

5. Enterprise & Shop Floor Integration:

   • Knowledge of configuring ERPi interfaces for ERP integration (SAP/Oracle), LIMS interoperability, and OPC connections to plant automation systems.

By acquiring these capabilities, you become qualified for vital industry roles such as MES Consultant, MES Engineer, EBR Author, Automation Specialist, and Life Sciences Manufacturing IT Analyst.