Success

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MES Consulting

Full Integration Assembly and Packaging Lines
Project Details
Upgraded Paper on Glass Assembly and Packaging lines to a fully integrated PAS-X digital system for one of the world’s leading pharmaceutical companies. This transition streamlined process workflows and communication with automation equipment
Our Solutions
  • Level-2-Integration Support
  • Recipe / MBR Design
  • CSV / Validation of built recipes
  • Optimization of process workflow
  • System Configuration and Parametrization
  • Go-Live Support & Hypercare
  • Facilitating workshops as an intermediary between
Value Added
  • Successful PAS-X deployment within project deadlines
  • Seamless integration of PAS-X and Level-2-systems
  • 100% Electronic Batch Record
Validation for an MES PAS-X System Upgrade
Project Details
Full validation for an MES PAS-X system upgrade, including new customization features and bug fixes offered to one of the world’s leading pharmaceutical companies. Validation support provided in the quality environment and effectively implemented in the productive environment.
Our Services
  • Project timelines definition and coordination of project activities until project GO-live
  • Evaluation of MES PAS-X upgrade system changes and validation scope definition
  • Validation approach definition along with the Customer’s in-house team
  • Full CSV documentation creation and/or review (Validation plan, Risk assesment, IQ/OQ/PQ test protocols, Traceability Matrix, Validation report…)
  • OQ dry-run and formal execution in QA environment using Micro Focus ALM software
  • MES PAS-X Bug detection and formal documentation (defect/deviation and CAPA task creation)
  • Facilitating coordination between different departments (IT, QA, MBR designers, etc.) to ensure seamless communication of challenges, needs and requirements
Value Added
  • Successful MES PAS-X system upgrade validation and implementation in the productive environment within project timelines
  • Validation of new features and bug fixes critical to production
  • Fast response and adaptation to OQ testing scope increased requested by the customer, while maintaining project timelines
Paper On Glass Design and Process Mapping
Project Details
Implemented Guided Execution (Paper on Glass) on Manual Wash and Utensils Autoclave for one of the world’s leading pharmaceutical companies. Trained local PAS-X team on PAS-X Recipe Designing and Process Mapping.
Our Services
  • Project Management
  • Organizational Change Management
  • Process Mapping
  • ESP Design
  • PAS-X Training
  • Strategy Building
  • Facilitating PAS-X workshops
  • Facilitating Level 2 (PLC, SCADA) Integration workshops
  • Demonstrating PAS-X to the end-users
Value Added
  • End-users gained confidence in the use of PAS-X
  • Operators and local management had a clear understanding of PAS-X

IT/OT And Automation Integration

Integration Workshops
Services Provided
  • Setup master data to replicate production system
  • Configure MSI interface for testing during workshop
  • Creation of testing MBR to easily reproduce testing scenarios
  • Setup of SOAP interface for material handling messaged
  • Coordination with machine vendor and middleware software providers
  • On Site support for Integration workshops
Value Added
  • Identify issues before machine is validated
  • Entire communication chain is tested leaving no unknows or assumptions
  • Reduced deviations at FAT and SAT
  • Provides machine vendor opportunity to test PAS-X connection at their site

Advanced Analytics

21 CFR Compliance Reporting
Project Details
Solution to automation system to customize 21 CFR part 11 reporting without any scripts. Auto back up and restore utility to generated back ups on user defined intervals.
Our Solutions
  • Customized reporting using the tool‘s NO CODE reporting module
  • Acquire data as per customer’s needs with the drivers to leading automation PLC’s and SCADA systems
  • NO CODE distribution layer enabled customized back up/restore options
Value Added
  • Successful designing of 21 CFR part 11 compliance reports within few hours
  • No programming expertise required to design reports
  • Report development time reduced to 2 days from 4 weeks

Serialization Solutions

Customer-based Service Level Agreement (MAH/CMO Pharma)
Project Details
Meticulously crafted to guarantee optimal performance and reliability, backed by robust infrastructure and expert support teams. Prioritizing prompt response times, ensuring minimal downtime for clients. Continuously monitor and refine our SLA to adapt to evolving technological landscapes and client needs, ensuring sustained excellence in service delivery.
Our Services
  • Monitoring of EU Hub Alarms and Alerts
  • Evaluation and Assessment of each Patch and RoadMap Release
  • Onboardings, new partners/products, troubleshooting and good practices
  • Dedicated support team available 24/7
  • Short resolution time, with different level of severities and defined escalations
  • Prompt response times to any issue or inquiry
  • Defined SLA escalations Scada Engineer
Value Added
  • Customized solutions to align perfectly with client’s business objectives
  • Weekly meetings to address the status of the current incidences
  • Personalized Consulting: Technical assistance, upgrades or customization
  • 100% effectiveness in solving the issues
  • Knowledge of all martkets regulation