IT & AUTOMATION

Be prepared for the future

Development in IT and Automation is very strong. Who would have thought that in a few years we have gone from talking about servers, PLCs and local networks to cloud solutions, robots, big data, Pharma 4.0 and artificial intelligence?

This exciting development poses new challenges for a highly regulated industry and at the same time offers many new opportunities that a pharmaceutical company should embrace as well as secure the competitive advantages it offers in a connected world. 

AlfaNordic's IT and automation consultants possess expert knowledge in validation and project management of IT and Automation solutions. Likewise, we are also experts in change management; We know how changes anchored so that changes in work and business processes become part of the existing corporate culture.

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WE CAN HELP WITH OVERVIEW AND SYSTEM KNOWLEDGE

When choosing new systems or optimizing the company's systems, it is important to get the right solution from the start. Our consultants can assist in the process of clarifying the project, selecting a relevant supplier, making a plan and be responsible for the implementation.

WIDE EXPERTISE ACROSS THE AREAS

At AlfaNordic, we make great efforts to keep abreast of the latest trends in IT and Automation and keep our experienced consultants up to date. Therefore, we can help companies stay on top of upcoming challenges so that they are able to respond in a timely manner, saving time and cost. The ability to combine our expertise across our teams from validation and regulatory affairs to IT and Automation and project management is one of the strengths that characterize AlfaNordic.

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OUR EXPERTISE WITHIN IT AND AUTOMATION

Below are examples on types of tasks that we have solved

COMPLIANCE ACCORDING TO 21 CFR PART 11, EDURALEX VOL 4 ANNEX 11, GAMP 5, GDPR

  • When implementing, updating or expanding IT and Automation systems, it is essential to have a thorough knowledge of the regulatory guidelines. Our experienced consultants have the knowledge needed to prepare requirement specifications so that they also subsequently enable validation of the systems.

IMPLEMENTATION, PROCESS SUPPORT AND OPTIMIZATION

  • Based on a life cycle assessment of an IT or Automation system, we can offer support at all stages of the system. It is important to focus on the full process, to ensure that all phases can be documented correctly. AlfaNordic has experienced IT and automation resources that can manage and document all phases of a system's life cycle 

REQUIREMENTS SPECIFICATION, VERIFICATION & VALIDATION

  • As with all projects, it is important for IT and Automation that all requirements specifications are complete, accurate and testable is ensured from the start. Documentation must be available for all specifications and their criticality, to ensure that documentation and the validation level are sufficient to comply with applicable regulatory requirements. AlfaNordic has experienced IT and Automation people with in-depth process knowledge who can support and ensure the level in all phases of the project.

BUSINESS CASE, RISK ASSESSMENT & DIVIDEND REALIZATION

  • Preparing a business case, risk assessment and benefits realization are crucial elements for approving and succeeding for a project. It is essential to ensure that all elements are included and considered in the preparation of a business case and associated risk assessment. Missing elements have a direct impact on the project budget and benefits realization. We have experienced project managers who assist with the preparation and review of business cases, risk assessments and project execution plan that support benefits realization.

SUPPLIER, AUDIT & CONTROL

  • Auditing and management of suppliers is important to ensure that the quality of the deliverables as well as the supplier meets the specified requirements. An audit of the supplier and the level of documentation is an essential tool. AlfaNordic has IT and Automation project managers who are experienced in conducting supplier audit and management.

CONTACT US ABOUT IT & AUTOMATION

Find solutions in compliance, with the help of AlfaNordic. 

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René Stuhr

Team Manager, IT & Automation

Subject areas
IT
Automation
Customer contact

+45 31 78 72 55
RENS@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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