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.

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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

Find out what our customers say about us!

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

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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

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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

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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!

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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

Check out their website here!

 

Software publisher MES industry, MOM, industry 4.0

Check out their website here!

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.

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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.

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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!

Find out what our customers say about us!

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

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.

Our proposals

Analyze the impact on your business.

Define the transition program

Adapt product and competitive strategy.

Support and sustain your organization.

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