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FOCUSERA Academy is invited you to explore the following Consulting services:

We provide services to all manufacturing and services especially in food industries, medical devices and pharmaceutical industries

Integrated Management System:

During the last years many company try to find a creative way to manage all quality systems in simple way , but little companies find the way , on the other hand ISO organization develop a HLS to many of its standards that make easy to make very simple and compatible integrated system .

We provide an expert advice in building this integrated system so can deliver world-class quality management systems that not only meet applicable requirements, but provide a custom designed framework for efficient management of your organizational processes in many ways :-

1 – Gab Analysis: to assist current performance to target goals

2 – System STUECTURE:  Help employees to construct system documentation

3 – System Implement: help employees to implement documents in efficient way

4 – QMS development:  for systems deficient of processes, documentation, training, and improvement

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Internal Audit Outsourcing :

No time or professional resources to perform an internal audit on company system? No problem we will do that for you by a professional experts as  an independent internal assessment on behalf of your organization in order to identify nonconformances and opportunities for improvement, and we will assist you in your continuous improvement efforts. In addition, our audits will help you prepare for your second and third party audits including certification audits

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ISO Systems Qualification:

We support any organization to establish and implement any ISO system like

  • ISO 31000 Risk Management
  • ISO 50001 Energy Management
  • ISO 20000 Information technology — Service management — Part 1: Service management system requirements
  • ISO 27001 Information security management
  • ISO 20121 Event sustainability management systems
  • ISO 1004 Quality management — Customer satisfaction — Guidelines for monitoring and measuring
  • ISO 19600 Compliance management systems
  • ISO 21001 Educational organizations — Management systems for educational organizations
  • ISO 22301 Business continuity management systems
  • ISO 26000 Guidance on social responsibility
  • ISO 27001 Information technology — Security techniques — Information security management systems – Requirements
  • ISO 37101 Sustainable development in communities — Management system for sustainable development — Requirements with guidance for use

Food and beverage

Keeping food safe, sustainable and responsibly sourced

We support your organization to establish and implement and update any food safety systems like

  • All BRC Global Standards
  • food safety
  • packaging and packaging material
  • storage and distribution
  • Agents and broker
  • Food and Agri Food standards
  • GMP
  • HACCP
  • ISO 22000
  • FSSC 22000
  • Food Catering
  • Global Gap

Improvement Projects:

Are you suffering from many problems that effect in direct or indirect way in cost or performance? Or are you face complex problems in productivity or late delivery? If your answer yes so we here to help your company to eliminate more waste, save more money and efficiently execute their manufacturing strategies. We provide the expertise and tools you need to accelerate your progress and transform your business by :

 

 1 – Lean Six Sigma Projects (DMAIC )

2 – TOCLSS Projects

3- DSS

4- QFD & Triz Solutions

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Medical Devices:

Supporting your medical device business

We ensure patient safety while supporting timely market access for our clients Medical Device products globally.

We provide our customers with thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and accepted worldwide.

 

We offers certification services to support your global market access goals. We help you to get and implement:

 

Also we can help any organization in others different ways like

  • Stability studies
  • Packaging validation
  • Transit simulation study
  • Risk management
  • Clinical evaluation
  • Technical files
  • Usability study

 

 

Pharmaceutical:

We help pharmaceutical companies involved in developing complex molecules through every stage of their new product development process and lifecycle, our global services and solutions enhance your end to end manufacturing processes, providing you with the confidence that you are optimising the time to market, whilst ensuring patient safety. We help your performance and protect your brand and business reputation, safeguarding patients, profitability and shareholder value.

We support organization to establish and implement and update

  • GMP
  • Process validation
  • Clean room qualification and validation
  • Cleaning validation
  • Cleaning and sanitation and disinfectant process
  • Line clearance
  • Quality risk management
  • Stability study
  • Microbiology and sterilization process
  • CAPA
  • GLP
  • IQ, OQ, PQ
  • OOS & OOT

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