Computer System Validation
You can grumble about regulation. But it can also be used as an opportunity. For example, to further advance digitalization in quality management. So that your company becomes even more efficient and requires less time for quality checks or verification and documentation obligations. Sounds interesting, doesn't it?
#lifescience
What is computer system validation?
You know how it is. As a regulated company, you are under particular scrutiny. In the event of an incident, you have to prove that your IT systems are running properly. But did you know that such a process validation does not only concern your computer systems? Hardware, documentation, processes and people are also closely scrutinized. This can be quite time-consuming. Especially if you are modernizing your systems as part of the digital transformation.
Our experienced life science consultants will work with you to develop an optimal strategy: a concept that perfectly harmonizes legal requirements and your project requirements. And the documentation? That's part of the package.
#efficiency
How to become more efficient with quality management and computer system validation
There is no legal way around quality management and software validation. The good thing about this is that both will also benefit your company economically. The running costs for your quality management will decrease noticeably, while the quality of your products and services will even improve. And thanks to end-to-end digital processes, you can face the growing bureaucracy with confidence. With the help of our consultants, you can kill two birds with one stone: you meet all legal requirements and achieve a high increase in efficiency.
What is important for computer system validation and quality management
GxP-compliant system integration
Our consultants support your team with GxP/ISO-compliant computer system validation.
Qualification according to GAMP®5
Together we implement your validation according to the proven GAMP®5 rules and regulations with the V-model.
Certified according to ISO 9001:2015
With the quality that your team delivers, you will pass validation with ease. Our ISO 9001:2015 consulting will help you.
Everything from a single source
To ensure successful validation, we support your team with advice and modern solutions such as the Quality Management Pack.
Successfully implement your software validation project
Imagine having a partner at your side who is familiar with computer system validation and the regulatory requirements of GxP/ISO down to the smallest detail. And who supports your team with proven methods for system integration. This means that project success for your company is almost pre-programmed. And you benefit from a solid software validation plan. At the same time, you ensure that the documentation requirements are met in full. Our documentation package based on Microsoft Dynamics 365 Business Central supports you in implementing the validation of your ERP system in a legally compliant manner. The best prerequisites for efficient project management.
Further topics relating to the introduction of your new software
Project management consulting
The success of your project depends on many factors: an smart plan, the right methodology and how well you manage to get your team excited about your idea. The course for this adventure is set at the beginning. And our experts will support you wholeheartedly.
Software implementation
Software implementation is more than just a technical challenge. The new software changes your processes and your team learns new ways of working. Our consultants support you in implementing your ideas with modern project methods and efficient change and knowledge management.
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