Development in IT and Automation is very rapid. Who would have thought that in a few years we would go 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 are anchored, so that changes in work and business processes become part of the existing corporate culture.
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 characterise AlfaNordic.
The following are examples of our expertise within IT and Automation:
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 the systems may also be validated subsequently.
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 / are documented correctly. AlfaNordic has experienced IT and automation resources that can manage and document all phases of a system's life cycle.
Preparing a business case, risk assessment and benefits realisation are crucial elements when approving - and succeeding with - 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 realisation. We have experienced project managers who assist with the preparation and review of business cases, risk assessments and project execution plans that support benefits realisation.
When existing software systems (legacy systems) need to be updated or replaced it is essential to ensure that data, existing systems and solutions continue to function to maintain the validated state of the systems. A review will ensure compatibility between existing platforms and functionality. The new solution can highlight challenges that need to be addressed as part of the implementation or upgrade. AlfaNordic has consultants with many years of experience in this type of work who have worked with many different systems and applications as well as change management of business processes.
Auditing and management of suppliers is important to ensure that the quality of the deliverables as well as the supplier meet the specified requirements. An audit of the supplier and the level of documentation is an essential tool in this regard. AlfaNordic has IT and Automation project managers who are experienced in conducting supplier audits and management.
As with all projects, it is important in IT and Automation to ensure from the beginning that all requirements specifications are complete, accurate and testable. This means that documentation must be available for all specifications and their criticality in order 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.
AlfaNordic offers certified project managers based on project type and desired approach to the project. We have project management certifications such as PMP, SCRUM, IPMA (C), Agile.
Is change management saying the same thing 21 times? How about a burning platform? Both help, but more is needed. When the legislation is changed and the quality system is updated, the next audit result depends on the implementation. We have experience in getting organisations to work in new ways.
We are a specialized consulting department within AlfaNordic, serving the pharmaceutical and biotechnology industry. We feel able to compete with companies with much bigger size for the following reasons:
AlfaNordic follows up on the consultants and holds regular status meetings with both the client and the consultants.
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