AmpleLogic MES

AI-Based Manufacturing Execution System

AI Infused Pharma Manufacturing Excellence

Elevating Pharmaceutical Manufacturing Operations

Traditional Pharma MES (Manufacturing Execution System) come with significant challenges that hinder operational efficiency and scalability. These legacy systems are often rigid, requiring extensive customization to meet the unique demands of pharmaceutical manufacturing, which leads to higher costs and longer implementation timelines.

Their inability to integrate seamlessly with modern technologies like IoT, AI, and advanced analytics creates data silos, making real-time visibility and informed decision-making difficult. Outdated user interfaces further compound these issues, reducing usability and increasing the risk of errors and inefficiencies. Additionally, traditional MES struggle to adapt to evolving regulatory standards, putting organizations at risk of non-compliance and penalties.

Predictive Optimization

Use machine learning to predict bottlenecks and failures

Tailored Application

Address specific manufacturing requirements effortlessly

Resource Optimization

Optimize resource allocation through AI analysis of usage patterns

Seamless Integration

Real-time integration with equipment, SAP and other ERP systems, and applications

Components of AmpleLogic AI MES

Electronic Batch Record (EBR)

Captures and manages batch data digitally, ensuring real-time tracking, regulatory compliance, and complete traceability throughout the production cycle.

Electronic Logbook

Replaces traditional paper logs with a digital system that records equipment usage, maintenance, and cleaning, enhancing accuracy and accessibility of records

Master Batch Records (MBR)

Provides standardized templates for each product batch, defining materials, instructions, and quality parameters to ensure consistent production and compliance

Recipe & Process Management

Controls and manages recipes and production processes, allowing for flexibility in formulations and supporting precise adjustments for different product requirements

Facing these Challenges?

Regulatory Compliance

MES ensures traceability, data integrity, and regulatory compliance (cGMP, FDA, EMA), but demands extensive validation and documentation, adding complexity and cost to operations.

Data Integration

Pharma Manufacturing Execution System must integrate with ERP, LIMS, and SCADA, but differing standards, data formats, and legacy systems make seamless, real-time data exchange challenging.

Scalability and Flexibility

Pharma MES must scale and adapt to changing manufacturing needs, handling various processes, batch sizes, and formulations. Companies manage large-scale production and small batches.

Batch Management and Traceability

Pharma MES supports batch management, ensuring traceability of materials, ingredients, and processing history to enable quality control and recalls.

Switch to AmpleLogic’s AI-Powered MES for Transformation

AmpleLogic's AI-powered MES transforms pharma manufacturing by integrating legacy systems with advanced technology. It's AI Features like predictive analytics and anomaly detection enhance workflows, ensure regulatory compliance (FDA 21 CFR Part 11, EU Annex 11), and automate audits, improving efficiency and product quality.

Ace Pharma Manufacturing with AmpleLogic AI MES Software

  • AI-Powered Operator Guides

    Develop AI-powered operator guides that provide step-by-step instructions during batch execution, minimizing errors and deviations by guiding users through complex processes

  • AI-Driven Resource Optimization

    AI can analyse resource usage patterns and suggest optimal allocations, thereby improving operational efficiency

  • Real-Time Process Monitoring

    Monitor quality parameters continuously during production based on which notifications can be sent to respective users

  • Predictive Manufacturing Optimization

    Utilize machine learning algorithms to analyze historical production data and predict potential bottlenecks or failures in the manufacturing process

  • AI Automation for Accurate Batch Records

    Implement AI to automate data collection from manufacturing equipment, reducing manual entry errors and ensuring real-time accuracy in batch records

  • Design Batch Template

    Streamline batch planning, issuance and approval processes for enhancing operational agility

  • Streamline Processes

    Simplifies workflows and reduces inefficiencies, leading to improved productivity and cost-effectiveness

  • Auto Validation

    Ensures that production processes and outputs meet predefined standards and specifications, enhancing accuracy and compliance

  • On Screen SOPs

    Provides real-time SOPs to guide operators through production processes, ensuring consistency and adherence to best practices

  • Shop Floor Execution

    Real-time tracking of production processes ensuring efficient workflow management. Enables immediate response to issues, optimizing productivity and maintaining product quality

  • Guided Processes

    Offers instructions and prompts to assist operators through each stage of production, improving efficiency and reducing errors

  • Animated Activity Status

    Aminated icons of activity status helps associates easily understand the current ongoing activity taking place without hindrance

  • Detailed Indexing

    BMR number assigned to each product type and separate batch number given for easy tracking and assessment of product

  • Detects Discrepancies

    Swiftly detects and resolves non-conformances and deviations with an efficient exception handling module

  • Electronic Signatures and Audit Trails

    Electronic signatures ensure proper authorization, traceability, and compliance with regulatory standards. Keep record of audit trials across different fields

  • Reminders & Alerts

    Receive timely reminders for pending tasks and alerts for escalations for batch record approval. Automated email alerts for each stage of batch record approval

  • Product Label Management

    Manages product labelling within the system. Centralized control for product label consistency

  • Track User Activity

    Monitor user activity with precise date and time stamps

  • Execution and Monitoring

    Manages and tracks real-time production processes, ensuring efficient operations and adherence to schedules

  • Production Scheduling

    Coordinates and optimizes the allocation of resources and tasks to meet production goals efficiently

  • Modular Design

    Tailor processes with drag-and-drop interface for each batch. Effortlessly manage specific activities for individual batches

  • Seamless Integration

    Integrate with internal and third-party applications like SAP, DMS, eQMS etc. for data extraction

  • Packaging Components

    Handle diverse packing requirements according to product

  • Barcodes and QR Codes

    Improved traceability with barcode technology

  • Cloud based MES System

    Offers scalability and seamless integration with other cloud applications, enhancing data sharing and operational efficiency in manufacturing

  • MES System Integration

    Seamlessly integrates MES with existing enterprise systems, optimizing data flow and ensuring streamlined operations.

  • Role Based Access

    Role-based access for handling different layers of a process according to professional experience and learning

  • Electronic Signature

    Electronic Signature helps in authenticating processes thereby adhering to regulatory compliances proposed by US FDA, EU EMA, etc

Why Choose AmpleLogic AI MES?

AmpleLogic MES system delivers unparalleled advantages to pharmaceutical manufacturers with Shop floor execution, auto in-process checks and result validation. With dynamic dashboards, exception handling and real-time alerts, the software streamlines operations, mitigating compliance risks and boosting productivity. Experience the power of complete customization, seamless integration and top-notch security with AmpleLogic MES. Our solution ensures regulatory compliance with operational excellence and maintain the highest quality assurance standards.

Batch Planning

Streamline batch planning, issuance, and approval processes

Master Record Management

Maintain accurate records of raw materials, equipment, and SOPs

Recipe Management

Ensure precise dispensing, manufacturing, and packing processes

Electronic Batch Record

Integrate equipment and capture operator-based events seamlessly

Unlocking the Potential of Pharma MES: A Comprehensive Guide to Manufacturing Execution Systems in the Pharmaceutical Industry

Related Articles

Frequently Asked Questions

Through features like electronic signatures, audit trails, and adherence to global regulatory standards.

Yes, it offers 100% customization based on client needs, ensuring suitability for diverse production environments.

It provides complete electronic records, ensuring organizations are prepared for regulatory audits at all times.

With features like dynamic dashboards and automated notifications, it facilitates seamless collaboration and communication.

With its faster deployment process and continuous product upgrades, organizations can experience enhanced efficiency within a short timeframe.

A Manufacturing Execution System (MES) is a software solution that connects, monitors, and controls manufacturing processes on the shop floor. It provides real-time data on production activities, helping manufacturers optimize operations, improve efficiency, and ensure product quality. MES systems bridge the gap between enterprise resource planning (ERP) and production equipment.

Yes, Amplelogic offers a cloud-based Manufacturing Execution System (MES) that provides manufacturers with the flexibility and scalability they need to optimize their production processes. Our cloud solution enables real-time monitoring and management of operations from anywhere, ensuring improved efficiency, enhanced collaboration, and seamless integration with existing systems. Experience the benefits of a modern MES with Amplelogic’s cloud-based offering.

A Manufacturing Execution System (MES) in production is a software solution that monitors and manages manufacturing processes in real-time. It connects production equipment with enterprise systems, enabling efficient scheduling, quality control, data collection, and traceability, ultimately enhancing operational efficiency and product quality on the shop floor.

 

Contact us

Your Pharma Automation Starts Here

Schedule a Free Demo
Request a Demo