This exciting development poses new challenges for an industry that is highly regulated. But at the same time, this new technology offers many opportunities which pharmaceutical companies should secure if they want to gain a number of competitive advantages in a closely linked world.
NIRAS’s IT and automation consultants possess expert knowledge within validation and project management of IT and Automation solutions. In addition, we are also experts in change management. We know how changes are anchored so that changes in work and business processes become a part of the existing corporate culture.
We can provide overview and system knowledge
When choosing new systems or optimising existing company systems, it is important to find the right solution from the beginning. Our consultants can assist you in the process of creating clarity about the project, choosing a relevant supplier, making a plan and being responsible for the implementation.
- Compliance according to 21CFR Part 11, Eduralex vol 4 annex 11, GAMP 5, GDPR
- Requirements specification, verification and validation
- Change management
- Supplier audit and control
- Project management (PMP, SCRUM, Agile)
- Implementation, process support, process optimisation (LEAN) and decommissioning
- Business case, risk assessment and profit realisation
- Review and analyses of "legacy systems"
Broad expertise across our areas
We focus extensively on keeping up-to-date with the latest trends within IT and Automation, as well as keeping our experienced consultants updated.
We can therefore help companies stay ahead of future challenges to make them able to react in a timely manner, which saves time and costs.
The ability to combine our expertise across our teams from validation and regulatory to IT and Automation and project management is one of the strengths that characterises NIRAS.
NIRAS’s expertise within IT and Automation
Compliance according to 21CFR Part 11, Eduralex vol 4 annex 11, GAMP 5, GDPR
When implementing, updating or expanding IT and Automation systems, in-depth knowledge of the regulatory guidelines is crucial. Our experienced consultants have the knowledge needed to prepare requirements specifications which also subsequently enables validation of the systems.
Implementation, process support, process optimisation (LEAN) and decommissioning
Based on a life cycle assessment of an IT or Automation system, we can offer support in all phases of the system. It is important to focus on the full course, to ensure that all phases are documented correctly. We have experienced IT and Automation resources that can handle and document all phases of the life cycle of a system.
Business case, risk assessment and profit realisation
Preparation of business cases, risk assessment and profit realisation are crucial elements for the approval and success of a project.
It is essential to ensure that all elements are included and considered in the preparation of a business case and the associated risk assessment. Missing elements have a direct impact on the project budget and profit realisation. Our experienced project managers provide support in the preparation and review of business cases, risk assessments and project execution plans in support of profit realisation.
Review and analyses of "legacy systems"
When existing software systems (Legacy systems) need to be updated or replaced, it is crucial to ensure that data, existing systems and solutions continue to function in order to maintain the validation 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 a part of the implementation or upgrade. We have consultants with many years of experience within this type of tasks who have worked with many different systems and applications.
Supplier audit and control
Auditing and managing suppliers is important to ensure that the quality of the deliveries as well as the supplier meets the specified requirements. An audit of the supplier and his documentation level is an important tool in relation to this task. We have IT and Automation project managers who are experienced in carrying out supplier audit and control.
Requirements specification, verification and validation
As with all projects, it is important for IT and Automation that it is ensured from the beginning that all requirements specifications are complete, accurate and testable. This means that there is documentation available for all specifications and their criticality to ensure that the documentation and validation level are sufficient to comply with applicable regulatory requirements. We have experienced IT and Automation employees with in-depth process knowledge who can provide support and ensure high levels in all of the above project phases.
Based on project type and desired approach to the project, we can offer certified project managers. We have certifications within project management such as PMP, SCRUM, IPMA(C) and Agile.
When the legislation is changed and the quality system is updated, the next audit result depends on the implementation. We are experienced in making organisations work in new ways.