Address specific manufacturing requirements effortlessly
Real-time integration with equipment, SAP and other ERP systems, and applications
Electronic signatures and audit trails ensure data confidentiality and traceability
Regular product upgrades ensure organizations stay ahead of industry standards
MES must ensure traceability, data integrity, and compliance with regulations such as cGMP and regulations by agencies like FDA, EMA, and others. This often requires extensive validation and documentation, increasing complexity and cost
Pharma MES needs to integrate with various systems, such as ERP , LIMS, and SCADA (Supervisory Control and Data Acquisition). Achieving seamless, real-time data exchange across these systems can be challenging due to differing standards, data formats, and legacy systems.
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, so MES must support variability without extensive reconfiguration.
MES systems in the pharmaceutical industry must ensure high data integrity, as any unauthorized change or data loss can have serious consequences for patient safety and regulatory compliance. The challenge lies in managing secure, audit-trailed data storage and access control.
Pharma MES must support complex batch management, from raw material receipt to finished product. It needs to ensure complete traceability of materials, ingredients, and processing history to facilitate quality control and recalls, if necessary.
Managing an MES demands skilled professionals knowledgeable in both IT and pharmaceutical processes. Training staff to use MES efficiently while keeping up with technological advancements and regulatory updates poses a significant challenge for many organizations.
Streamline batch planning, issuance, and approval processes
Maintain accurate records of raw materials, equipment, and SOPs
Ensure precise dispensing, manufacturing, and packing processes
Integrate equipment and capture operator-based events seamlessly
Captures and manages batch data digitally, ensuring real-time tracking, regulatory compliance, and complete traceability throughout the production cycle.
Replaces traditional paper logs with a digital system that records equipment usage, maintenance, and cleaning, enhancing accuracy and accessibility of records
Provides standardized templates for each product batch, defining materials, instructions, and quality parameters to ensure consistent production and compliance
Controls and manages recipes and production processes, allowing for flexibility in formulations and supporting precise adjustments for different product requirements
Streamline batch planning, issuance and approval processes for enhancing operational agility
Simplifies workflows and reduces inefficiencies, leading to improved productivity and cost-effectiveness
Ensures that production processes and outputs meet predefined standards and specifications, enhancing accuracy and compliance
Provides real-time SOPs to guide operators through production processes, ensuring consistency and adherence to best practices
Real-time tracking of production processes ensuring efficient workflow management. Enables immediate response to issues, optimizing productivity and maintaining product quality
Offers instructions and prompts to assist operators through each stage of production, improving efficiency and reducing errors
Aminated icons of activity status helps associates easily understand the current ongoing activity taking place without hindrance
BMR number assigned to each product type and separate batch number given for easy tracking and assessment of product
Swiftly detects and resolves non-conformances and deviations with an efficient exception handling module
Electronic signatures ensure proper authorization, traceability, and compliance with regulatory standards. Keep record of audit trials across different fields
Receive timely reminders for pending tasks and alerts for escalations for batch record approval. Automated email alerts for each stage of batch record approval
Manages product labelling within the system. Centralized control for product label consistency
Monitor user activity with precise date and time stamps
Manages and tracks real-time production processes, ensuring efficient operations and adherence to schedules
Coordinates and optimizes the allocation of resources and tasks to meet production goals efficiently
Tailor processes with drag-and-drop interface for each batch. Effortlessly manage specific activities for individual batches
Integrate with internal and third-party applications like SAP, DMS, eQMS etc. for data extraction
Handle diverse packing requirements according to product
Improved traceability with barcode technology
Amplelogic's Cloud based MES system offers scalability and seamless integration with other cloud applications, enhancing data sharing and operational efficiency in manufacturing.
Graphical representation, contextual search and voice recognition for addressing challenges of tomorrow
Seamlessly integrates MES with existing enterprise systems, optimizing data flow and ensuring streamlined operations.
Electronic Signature helps in authenticating processes thereby adhering to regulatory compliances proposed by US FDA, EU EMA, etc
Role-based access for handling different layers of a process according to professional experience and learning
Continuous monitoring of environmental conditions is paramount in the pharmaceutical industry and various other sectors, ensuring adherence to regulatory standards product quality. Regulatory bodies like
In pharmaceutical manufacturing, ensuring consistent production of high-quality products is paramount. One of the key elements in achieving this goal is the rigorous control of
The pharmaceutical industry is increasingly moving towards paperless Batch Manufacturing records (BMRs) driven by regulatory expectations and the need for enhanced data integrity and compliance.
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.
Â
We’re here to address your inquiries and assist you in identifying the solutions that best align with your requirements. Here’s why choosing us is your strategic advantage:
Schedule a call at your convenienceÂ
Discovery and consultation session
Get your custom proposal
Annual Product Quality Review
Electronic
Logbook System
Laboratory Information Management System
Manufacturing Execution System
Calibration & Preventive Maintenance
Regulatory Information Management System
Learning Management System
Environmental Monitoring System
Electronic Quality Management System
User Access Management System
Document Management System
Quality Control
System
Cleaning Validation Software
Process Validation
Software
