Validating Enterprise Systems - Questions Answered

Thanks to those of you who attended the first session on our 'virtual book tour' - in which we looked at the some of the basics of validating corporate applications, based on the the book "Validating Enterprise Systems: A Practical Guide"

A number of people submitted questions before the webcast which we answered during the session and we also had time to answer a couple of questions submitted at the end of the session. You can see a recording of the webcast and download a copy of the slides at the Business & Decision Life Sciences website.

There were however a couple of questions that we didn't get around to and as usual we've addressed them here:

Q. What challenges to you see for Enterprise Systems in the next five years?

A. Over the past five years we've seen the functional footrpint of systems such as ERP, CRM, LIMS, PLM etc being extending beyond their traditional boundaries (as discussed in the webcast). However, even where business processes are extending beyond traditional 'silos' in the business, the extended business process is still very much within the enterprise.

We are already seeing Life Sciences companies struggle to extend their business processes beyond their own boundaries and this is becoming even more important as companies collaborate and outsource more. (I'm talking about this very issue at the Xavier / FDA Global Outsourcing Conference next week).

Enterprise systems will therefore need to be capable or orchestrating business process and consolidating data from across the extended enterprise - meaning across business partner, supplier and even customer processes and systems. While the tools and technical standards exist to start to do this today, very few companies are actually taking this step and it is an area which promises true business advantage.

Q. How do you see the use of Service Oriented Architecture changing the game with respect to validation?

A. This is really linked to the previous question. SOA - and Business Process Orchestration- is one of the enabling technologies that allows end-to-end business processes to be defined, monitored and optimized both within the traditional enterprise boundary and across the extended enterprise.
These changes will bring compliance and validation challenges.

Key regulatory business processes - such as adverse events management and product recall - will need to be coordinated across the extended enterprise. This will require validation of the end-to-end business process as well as the computer systems validation of the individual applications and Middleware / SOA components.

Like the technology, the techniques for this already exist but relatively few organizations know how to achieve such compliance efficiently in complex organizations and with such integrated architectures. This will be a challenge both to business process owners, to IT and especially to Quality and IT Compliance and CSV professionals, who sometimes tend to lag behind in applying well established principles to new technologies. It's therefore important that we keep up not only with the changes that have taken place over the past five years, but with the changes that are still to come.


In the next stage of the 'virtual book tour' we'll be looking at how the approach to risk management has changed in the last five years - we hope you'll be able to join us for that session, which is on 3rd October (registration is available here)