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)

Product Lifecycle Managament Integration in Life Sciences

Sitting in on some of the conference session yesterday, looking at interfacing Product Lifecycle Management (PLM) solutions, it was quite obvious that not all PLM solutions are created equal.

PLM is one area where Oracle has grown strong through acquisition, initially by acquiring Agile. This brings arguably the best PLM solution for medical devices companies - what many still know as the Agile A9 product. Oracle also had a process version but is mainly used in food and beverage and although there is some good process functionality it was not specialized enough to manage the drug development lifecycle.

Then in June this year Oracle announced its intention to purchase the IP of Conformia, bringing a strong product to manage the drug development lifecycle into their portfolio, with the intention to integrate this into the Agile product line.

This will provide large Life Sciences companies first rate products for either medical device development and design management or for managing the drug discovery and development process. This will also provide some flexibility to manage the lifecycle of products that are manufactured using either discrete or process manufacturing operations.

Although many take a simplistic view, the world isn't as simple as medical devices companies use discrete manufacturing and pharmaceuticals uses process. In some cases medical devices use batch manufacturing and pharmaceuticals need discrete. At the PLM level, the medical device Quality System Regulations have specific requirements for device development which Agile A9 meets very well, but not so Conformia.

Back to the topic of interfaces: While Oracle is doing a good job in developing standard process integrations between A9 and their core ERP systems (E-Business Suite and JDEdwards, using AIA PIPs), there is a growing realization that the combination of regulatory requirements for managing the various lifecycles of devices or drugs and discrete or process manufacturing means that there will need to be complete flexibility to interface either of the two 'flavors' of PLM to either discrete or process manufacturing solutions in Oracle's own (and competitors such as SAP) ERP systems.

Oracle's AIA framework certainly provides that opportunity and is no doubt the easiest way to develop such integrations. Indeed, Oracle has a roadmap to develop such Process Integration Packs, but it will be a while yet until the Conformia product is integrated into Agile and the AIA PIPs developed.

From a business perspective this means that Life Sciences companies looking to acquire PLM solutions (not only from Oracle) really need to understand:

• The nature of their product development lifecycle
• The regulatory requirements which govern their PLM processes (depending on device class or drug profile)
• The nature of their manufacturing process - discrete, process or possibly mixed mode for some product lines
• Exactly how they want to integrate their PLM systems to their manufacturing systems from a business process perspective

It is this that will drive the functional requirements of their interface and determine whether an out-of-the-box integration will deliver what is needed, or whether integration tools will be needed to develop some customer elements of the interface.

On a positive note, for Life Sciences customers who have taken the step to integrate their PLM and ERP systems and processes, there is a good return on investment both in terms of reducing costs and helping maintain compliance through the design, development and introduction of new products and new versions of products. With respect to this latter point, with regulatory authorities now looking at risks introducing during new product introduction (or scale up) it is good news that these concerns can be addressed at the same time these processes are made more efficient.