VALIDATION

Optimise your production and increase productivity

It is cost-intensive to establish and maintain production equipment within the life science- industry. Therefore, it is important to ensure the most optimal exploitation and possible performance. Changes can contribute to increment in production. It can also create challenges when it comes to coordinating between stakeholders within the process. It will often rise questions such as: What changes does it require to optimise the production? How fast can it be done? Can the everyday production continue while establishing the new one? How do we make sure that the changes are implemented in a secure way? What about the documentation? How do we ensure high quality in the project? Which stakeholders must be involved to create a coherence in the processes?

AlfaNordic’s Validation team (VAL-team) understands the importance of effective and coherent processes. We have experience with production, and we solve all kinds of tasks, e.g. strategy, planning and tests for documentation and compliance in projects. We are hereby able to assist companies in life science, to get most value of their production equipment.

Creating effective processes will increase the productivity. To be able to succeed it demands specialists in validation. Optimise your production and increase productivity, with the help of AlfaNordic.

COORDINATING

Validation projects often have many stakeholders, both internally and externally. Correlation and overview are therefore important factors to ensure focus on what creates value.

We handle stakeholders on all levels in the organisation, and can speak their terminology, from hands-on factory work to managerial work. In that way, we create an overview of the separate tasks in the project’s different phases.

From a risk and scientific point of view, we ensure that resources are used most efficiently. The governmental requirements regarding equipment, production facilities and documentation, are all key factors to ensure compliance and correlation.

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SHARING PROFESSIONAL KNOWLEDGE

Professionalism is fundamental to our work, and our consultants have experience and knowledge within different fields. No one can know everything. We therefore strive to work, based on knowledge sharing and competent feedback:

When the individual consultant work out a task, it allows for internal issue solving. This means, that we embrace each other’s knowledge and experience more widely for the benefit of our customers.

What we do not know yet, we will find out. Professional curiosity and innovation are part of our consultants’ DNA. It is especially being expressed when companies ask professional challenging questions. It challenge the professional curiosity and will, to appropriate new knowledge and create innovative solutions.

VALIDATION FROM A TO Z

A project has multiple phases, and what determine the level of AlfaNordic’s assistance, depends on the individual company’s needs:

We help some customers to set the level and develop a general strategy for validation. Other customers need assistance to plan and implement solutions or practical tasks.

Both the project- and the management organisation demand the right match of resources to ensure an optimal process. We can ease the assigned team and ensure that you reach your goals with satisfaction – no matter what the task is. We handle everything from optimisation and revalidating of existing processes, installation of new equipment or new processes, expansion of the production etc.

Professionally, we embrace and understand that things must be coherent. We strive to assist on all levels and ensure a solution that works for the individual company’s situation.

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OUR EXPERTISE WITHIN VALIDATION

Below are examples on types of tasks that we have solved

PRODUCTION

  • Cleaning validation
  • Environmental monitoring, also in aseptic productions
  • Automation
  • IT-validation
  • Temperature mapping, including transport validation
  • Decommissioning

PROCESS OPTIMISATION

  • Optimising of existing processes, including Lean and OEE
  • Establishment and qualification of new processes
  • Mapping flow and troubleshooting on certain stages
  • ASTM2500E
  • Project management
  • Coordinating of stakeholders.

EQUIPMENT

  • Qualification of equipment
  • Bio process, chemical process, and production equipment
  • Packaging lines
  • Filling lines
  • API manufacturing
  • GMP documentation (RA, URS, DQ, IQ, QQ, PQ, SOPs, protocols, composing modification procedures, risk analysis, deviations etc.)
  • Validation of temperature-controlled rooms and equipment. Read more here.

Do you want further information?

Let's talk about your company and the possibilities for a possible Cooperation.

CONTACT US FOR VALIDATION

Optimise your production and increase productivity, with the help of AlfaNordic.

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Lisbeth Gandrup

Team Manager, Validation & Qualification

Subject areas
Temperature mapping, transport, space and equipment.
Qualification of Equipment
GMP-dokumentation

+45 53 54 24 78
LGA@alfanordic.com

Lisbeth Bonde

Business Developer  

Subject areas
Customer contact
Offers and contracts
Follow-ups

+45 31 44 75 44
LIBO@alfanordic.com

LET'S GET STARTED

BOOK A CONSULTATION, FREE OF CHARGE 

Are you ready for changes? Let us talk about your company’s ambitions and how we can break through in a new country.

Get an idea of what we can offer, by participating in our inspiration meetings. Here our specialists share their knowledge and experiences.

MEET OUR SPECIALISTS - PARTICIPATE IN OUR INSPIRATIONAL MEETINGS

CONTACT US

Do you have any questions, or do you want to know more? Contact us. You can find our contact information below. We look forward to hearing from you.

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