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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
Transforming Medical Device Manufacturing through Critical Manufacturing MES
Project Details
A leading global medical device manufacturer operating a network of highly regulated production facilities worldwide. As part of its digital transformation roadmap, the organization sought to modernize manufacturing operations, improve process standardization, strengthen data integrity and enhance production visibility across key manufacturing processes.
Our Services
  • Implemented Critical Manufacturing MES capabilities and Modules
  • Paperless Manufacturing : Replaced manual paper records with digital workflows
  • Real-time Genealogy : Complete device-level traceability and Electronic Device History records
  • Automated Material Consumption : Accurate inventory transactions and reduced manual reconciliation
  • SOP Enforcement : Digital work instructions and controlled execution of manufacturing processes
Value Added
  • Improved production visibility through real-time tracking
  • Faster genealogy retrieval from hours to minutes
  • Reduced documentation-related manufacturing errors
  • Increased traceability and audit readiness
  • Reduced efforts required for batch review and release
  • Improved quality monitoring through SPC and NCMR
Learn more about MES Consulting

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
Learn more about IT/OT And Automation Integration

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
Learn more about Advanced Analytics

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
Learn more about Serialization Solutions

GxP Compliance & Strategic Consulting

Validation Consulting for a Greenfield SAP S/4HANA Implementation at a Medical Device Manufacturer
Project Details
  • Industry: Life Sciences 
  • Sector: Medical Device Manufacturing 
  • Location: Germany 
  • Challenge: Needed validation for MES PAS-X upgrade and SAP S/4HANA rollouts with GxP compliance 
Our Solutions
  • Developed hybrid-agile validation framework aligned with agile implementation 
  • Performed FRA at product backlog level 
  • Conducted GxP assessments at transactional level 
  • Proposed reusable Fiori App validation methodology 
  • Suggested a master template-based rollout approach for multiple sites 
Value Added
  • Ensured GxP-compliant SAP and MES validation 
  • Enabled scalable validation across global sites 
  • Improved efficiency and clarity in validation of Fiori apps 
Auditing & Remediation: Pharma Manufacturing Company’s CMO Audit Partner With PharmaX Solutions
Project Details
  • Industry: Life Sciences 
  • Sector: Pharmaceuticals 
  • Location: Pan Europe 
  • Challenge: Difficulty in auditing multiple CMOs across Europe consistently and effectively 
Our Services
  • Deployed PharmaX Auditing and Remediation Toolkit 
  • Aligned auditing model to customer requirements 
  • Deployed dedicated auditing teams to various CMOs 
  • Provided ongoing audit and remediation support through tailored models 
Value Added
  • Streamlined CMO auditing process 
  • Ensured consistent compliance across vendors 
  • Reduced internal audit burden for the customer 
Computerised System Validation: MES Validation for Pharma Manufacturing Company
Project Details
  • Industry: Life Sciences 
  • Sector: Pharmaceuticals 
  • Location: Denmark, Spain 
  • Challenge: Validation of MES system for both site and global rollouts 
Our Services
  • Used PharmaX MES Validation Toolkit 
  • Provided on-site validation experts 
  • Developed optimized validation processes 
  • Maintained system in a validated state through structured support 
Value Added
  • Ensured timely validation of MES system 
  • Minimized compliance risks during rollouts 
  • Created a sustainable validated environment 
Learn more about GxP Compliance & Strategic Consulting