If you have decided to establish a CTMS system in your company you might think about the nessecity of having multiple installations or instances of this system.
More than one CTMS installation? Why that?
Of course you will ever work with one instance of your company’s CTMS to have one data basis to do reporting and get specific data. But there are other demands towards the implementation process of the CTMS that form the need to have more than one installation. Our proposal is to have three to four instances which does not mean that you will need four times the hardware – thanks to virtualization technologies.
Installation No 1: Productive Environment
This installation is the one productive environment. This system is where all your staff works in and enters real data. This system’s database is the source for all reporting.
Typically, this installation runs on the most powerful hardware of all four. Sometimes this system is even driven by a load balancing server to provide even more performance.
Installation No 2: Test Environment
Never stop a running (CTMS) system! Every change, every update, every bugfix has to be checked before it is implemented in the productive system (1) to avoid any problems. Therefore you should implement a dedicated test environment which is a copy of your productive environment.
Since this implementation is not very likely to be used by many users, it might be sufficient to run it on a virtal server.
Installation No 3: Training Environment
Having a technical solution is one part of the story, having your staff trained to use the system in the right manner is the other part. Independently whether you decide to have classical classroom trainings, e-learnings or a blended learning scenario you will have to have a installation of your CTMS which is espescially installed for training demands.
This system has to be well prepared to provide different training scenarios.
Installation No 4: Validation Environment
Most of the CTMS installations are nowadays validated which means that they comply with the regulations of 21 CFR part 11. To pass the necessary validation process it is a must to have a dedicated validation system to seperate the entries being made while working on test scripts from the productive trial data.
Of course it is possible that you have special conditions which make even more installations necessary, but the four mentioned CTMS installations are a well-founded approach for a professional implementation of your Pharma-IT landscape.
