Product Quality Management
The key challenges of product quality management
Our experience has taught us that these three issues are key to better manage product quality.
75%
reduction of the closing time of ongoings
Removing the Backlog
-20
deviations in progress in the routine portfolio
About
Manage quality to ensure product compliance
• Do you encounter a significant backlog of your deviations?
• Are Root causes not identified and events are recurrent?
• Are deviations not managed and brought under control?
• Is your customer service impacted by delays related to quality issues?
• Do you lack investigative expertise due to high turnover?
A selection of our customers whose quality control has made it possible to guarantee the conformity of the products
Leverage of actions
Selection
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Processes
The key challenges of manufacturing process control
Our experience has taught us that these three issues are key to bring under control manufacturing processes
50%
saving development and transfer time
Loss reduction
50%
more OEE
About
Putting under control the process and making it reproducible from development to industrialization
• Are the critical parameters unknown to your teams?
• Is the process not robust or is difficult to reproduce?
• Is knowledge of your processes not shared?
• Does process variability impact your upstream and downstream operations?
A selection of our customers whose manufacturing process control has made it possible to produce better and faster
Leverage of actions
Selection
Fully map the process(es) and hazards
Identify critical and driving parameters (CPP/CQA) and optimal adjustment ranges
Conduct a product/process risk analysis
Re-define the means of detection and control
Train teams in the new process(es)
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BiotechStartupBooster
The key challenges of the Biotech Startup Booster
Two axes are to be considered: the strategic/financial axis and the operational/field axis
Market Access Acceleration
Deployment of an industrial culture
Increase in value
Member of:
About
Increase value and accelerate growth
• Do you want to co-develop with a commercial, industrial or technological partner?
• Are you looking to strengthen your equity, financial your development program?
• Do you want to secure the scale-up phase and your industrialization?
• Do Your teams have to be trained and integrate industrial reflexes?
• Do you need to install and display regulatory compliance (GMP/GxP/FDA)?
A selection of our customers who asked us to boost their development!
Leverage of actions
Selection
Seeking funds to optimize development costs
Structure and formalize processes to implement a robust Quality system
Mobilize atryon expertise (PMO, managers, etc.) on key functions to accelerate processes (QA/QC, development, manufacturing, supply chain)
Align capacities, means of production and processes with the development roadmap
Train and coach teams in GxP/Aseptic Culture
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Enhanced eBR
Data Analytics & Big Data for Industry 4.0
Software publisher MES industry, MOM, industry 4.0
The key challenges of digitization of the Batch Records
Our experience has taught us that these three issues are key to the digitization of your Batch Records.
50%
streamlined and simplified data
10%
reduction of material costs
80%
reduction of cycle time
by the way
Digitize your batch file while optimizing your industrial performance
• Are you having trouble keeping up to date too many master data ?
• Are you finding it difficult to consolidate your data to fuel Continuous Improvement?
• Do you have significant costs related to the file review and release processes?
• Your cycle time does not allow you to meet your customer commitments?
Leverage of actions
Selection
Streamline and Simplify Batch Folders
• Identify critical parameters
• Analyze data criticalities
• Adhere to flows
Monitor the process(es) in real time
• Implement eBR / Paper-on-glass
• Measuring OEE on lines
• Install control cards on lines
Optimize the process(es)
• Deploy Analytics
• Make Data vizualization on your equipment
• Get automated reportings
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LeanLab
The key challenges of lab performance
Our experience has taught us that these three issues are paramount to optimize the performance of your laboratories.
50%
reduction of planning effort
30%
lab productivity optimization
95%
adherence to lab commitments
by the way
Optimize your control or development laboratory
• Are you witnessing an « Out-of-Sync » situation between lab flow and plant flow ?
• Are you currently observing a lack of robustness in your analytical methods ?
• Are your teams having trouble prioritizing QC activities?
A selection of our customers whose lab performance optimization has no more secrets!
Leverage of actions
Selection
Define and deploy the proper tools (LIMS...) and the proper processes
Design and implement Performance Management standards
Manage workload/capacity balance
Set up the Data Integrity program
Simplify and deploy a digitized efficient lab planning
Improve interfaces (supply, QA, production)
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Medical Devices and Diagnostics
The medical device industry environment is changing significantly
impacting the balance of the business, both operationally and on the strategic direction of the company. Atryon expertise applied to medical devices allows you to leverage the issues for your organization while involving the skills specific to your business.
Our vision
Context
- Geopolitics and economics
- Market consolidation
- Regulatory developments
- Product Technologies
Issues
- Product and industrial strategies
- Market access
Industrial challenges
- Strategic adjustment
- Operational implementation
- Compliance of organizations
- Business processes performance
Our Offer
In addition to our expertise, from strategy to results
we also respond with an adapted positioning to the Medical Devices Industries.
Compliance and efficiency of QMS processes
Technical-regulatory strategy and certification
Risk management and product quality
State-of-the-art and post-market management
By the way.
EU Medical Device Regulation 2017/745
In addition to the complexity of implementation and the impact on product compliance, the new regulations challenge the technical-regulatory management product/system for a radical process approach.
It also redesigns market strategies and may challenge the business model.
The accompaniment offered by atryon allows new capabilities in this environment.