Implementing software through computer validation

Regulated businesses, e.g. in pharma & medical technology, must provide documented proof that their critical computer-controlled systems perform consistently and meet the required specifications. 

Computer system validation (CSV) applies to the entire life cycle and includes the entire computerized system. So the validation covers not only the software components but also 

• the hardware
• the processes
• the documents and 
• the people involved in the system. 

But what if your company lacks sufficient experience or resources for computer system validation (CSV)? 

Either way, without validation, the system cannot operate productively.

And even if the knowledge and resources are available... How do you find a reliable partner whose implementation method is compatible with the required validation processes? One that provides support with the necessary documentation processes and – even better – actually provides the required documentation?

Our experts will assist you with computer system validation in compliance with GxP/ISO requirements and ensure the regulation-compliant integration of your system.

We know what documentation is required of you and will be able to advise and actively assist you, e.g. with:

• a qualification approach in accordance with the GAMP®5 / life-cycle model (V-model)
• a pre-assembled documentation package (Validation Toolkit) based on Microsoft Dynamics 365 Business Central 
• a proven & inspected methodology and
• an effective Change Control procedure. 

For the Microsoft Dynamics 365 Business Central ERP system, we provide a ready-to-use validation package based on GAMP®5. This includes:

• all the necessary documents
• predefined risk analyses 
• additional templates and
• recommendations that can be used directly in CSV projects.

This enables you to greatly reduce your validation activity processing time. It also provides transparency, allowing you to keep track at all times.

The toolkit can also be used as a foundation and for the operative continuation of all CSV activities

Validation should be based on a well-designed procedure. The GAMP®5 regulations with the V-model serve as an effective way to achieve this. The COSMO CONSULT validation method is also based on these regulations and delivers the required outputs in every project life-cycle phase. Since our approach is geared to this cycle, the system implementation can be implemented 

• with conventional project methods, e.g. the waterfall method
• with iterative, agile methods or
• a combination of the two.