Could someone let me know how and what all needs to be done as a part of Installation Qualification of an SAP or an ERP system?
The figure below shows a high-level representation of this methodology.
The “V-model” is a high-level concept illustration first introduced by the Good Automated Manufacturing Practice (GAMP) Forum, which was established by representatives from major international companies to interpret and improve the understanding of regulations for the development, implementation, and use of automated systems in pharmaceutical manufacturing. The V-model has been enhanced to more closely represent ASAP Focus methodology, but it remains consistent with the formally recognized software development life cycle.
Figure attached.
<img src=/uploads/db7093/original/1X/0f3b3dcdedd60af4aaf35db3d19d34873083ccd3.JPG">
While the ‘V’ model is good for a quick overview of the entire process, I’m not sure it answers the question.
What I do as part of IQ for a large software system includes (and this is just off the top of my head and is likely not complete - hopefully others will join in to make it more complete):
- Confirm that the server-side installation is in line with the software supplier’s recommendations (processor speed, memory, etc.)
- Confirm that the server-side support tools (e.g., SQL, etc.) are installed per supplier’s recommendations
- Ensure that someone has analyzed disk requirements and that adequate space is available
- Ensure all documentation is properly controlled
- Ensure a backup of the software exists
- Confirm that clients are properly configured (e.g., if access is via browser and only IE is recommended but clients have Firefox installed, there may be some issues)
- Assess data backup / recovery procedures
- If customizations are made, ensure the controls are in place to manage them under proper CM
- Evaluate known issues to determine if they will impact operations and ensure that controls are in place to mitigate such issues if they exist
Like I said, this is only what I can think of in a short time and I know it’s not complete. It should get you started and hopefully others will add to the list.
Also consider if the severs that the application reside on have being properly qualified.
High level process description diagram detailing how the whole application sits together.
In terms of the browser issue, usually companies specify the exact browser and version to be used when working on the application, CC maybe require if the browser is updated to the next rev.
I would be interested to hear more opinions on this.
Cheer
Involved in a validation and qualification SAP project, we have Prototype, DEV, QAS and Prod. Does development need to be qualified? We usually only qualify QA and Prod in other systems. Please advise.
Involved in a validation and qualification SAP project, we have Prototype, DEV, QAS and Prod. Does development need to be qualified? We usually only qualify QA and Prod in other systems. Please advise.