Cloud systems have come to stay. They brought multiple benefits but also a few problems for the pharmaceutical industry, being the most annoying one, the fact that cloud systems seem to be unable to settle in a given version.

This continuous upgrade process has found the pharmaceutical industry with a change management process that is not effective for managing them with the appropriate pace and using an acceptable number of resources.

 

So, the way in which changes in cloud systems are managed should be adjusted, but how?

  • The first and main element to be considered for an efficient change management in cloud system is the role in the technical verification of the changes of the supplier. The management of a cloud system is mainly delegated to the system supplier, and this cannot be done without a previous and suitable supplier qualification. This qualification must have demonstrated that the supplier has a good software development lifecycle, that includes the suitable development and documented testing of new functionalities and (really important) a good regression testing process. If you don’t know it by now, I’ll tell you that it is almost impossible to do this without a face-to-face audit.

 

  • The second key point is evaluating whether the changes are really affecting the company processes. Most times, the changes are either technical (solving problems or keeping components updated) or focused to provide new functionalities that the company may not need. The extent of the impact over the processes will allow setting the criticality level and thus the validation method.

 

  • Once the pharmaceutical company has evaluated that the change is not affecting its processes and provided that a good supplier qualification is in place, it is possible to affirm that the change management must be just focussed to verify that the new version of the software is still suitable for its expected purpose. This can be done by means of standardized User Acceptance Tests that are based on the system & company processes. They will not significantly change over a long period of time, and thus can be simply re-run for each change, with much less effort than having to build them each time (and even less effort if the company creates an automated validation test script – be aware this is the next step in system testing).

Of course, the benefit of this approach can be highly reduced if the companies need to build a rationale in the change control form each time (rationale that for sure will require some discussion along the review and approval path). Therefore, it is suggested to update the governance environment to pre-establish this rationale and the cloud system change management methodology. This way, new cloud changes , will be managed using the fast track.

 

Finally, it is important to remember that some topics must be agreed with the software supplier beforehand. The list of topics includes things like timelines, availability of documentation, availability of a testing environment, routes for communicating testing deviations, showstoppers management, etc. A good Service Level Agreement (SLA) is always a must when using cloud systems.

 

 

 

 

 

Sergi Arcas – Pharmaceutical Consultant at TDV