Global Outsourcing Conference Report

Over the last three days we've been taking part and presenting at the third Global Outsourcing Conference, jointly organized by Xavier University and the US FDA.

Although not the best attended of conferences this year, it proved to be one of the best in terms of content presented and the quality of the invited speakers, including a couple of key note addresses from senior members of US FDA. This resulted in some very interesting and beneficial discussions amongst the attendees, all of whom have taken home some thought provoking material and ideas for implementing positive change in terms of better securing the supply chain, assuring product and patient safety and in optimizing the performance of their extended enterprises.

The conference looked at a wide range of outsourcing and supply chain issues, ranging from the pragmatic management of outsourcing and supply chain management best practices, with a mixture of practical best practices from the pharmaceutical industry and research and experience from a number of leading Universities working in the field (presentations are currently available on the Xavier GOC website).

Of significant interest were the FDA presentations looking at the implications of the recent FDA Safety and Innovation Act (FDASIA - due to be signed into law next month) and the changes that this will have in terms of changes to GMP and GDP regulations.

There was a significant interest in the topic of serialization and ePedigree - which was covered in a number of sessions and signs are that companies are now realizing that rolling these solutions out will be necessary and more difficult than originally envisaged when compared to simpler pilot studies.

Supplier selection, assessment and management were also key topics with the focus on developing partnerships and relationships as the best way of meeting forthcoming regulatory expectations for the management of suppliers.

Business & Decision presented a deep dive session on the future challenges faced by ERP System and Process Owners, looking at the need to integrate with serialization systems, master data management systems, and supply chain partners systems. Acknowledging that many ERP systems were never designed to handle such a level of integration, the session looked at how middleware solutions such as Business Process Management solutions and SOA can be used to better integrate the supply chain.

Outsourcing clearly isn't going away and although some companies are looking to in-source some strategic products and services once again, the issues associated with outsourcing cannot be ignored. Although examples from India and China were much in evidence it was also acknowledged that outsourcing risks do not solely exist in so-called 'emerging economies'

This issues exist not only with product (API, excipients and other starting materials), but also with services such as IT services and it is clear that the US FDA expect companies to better manage their suppliers and supply chain.

For pharmaceutical companies looking to get involved in the debate there is the opportunity to follow the discussion on-line in the LinkedIn "Xavier Pharmaceutical Community".

In summary, the conference provided pharmaceutical companies with a comprehensive list of the topics they will need to be address in the next 1 - 3 years, which now need to be developed into a road map leading to on-going compliance, improved product and patient safety and more efficient and cost-effective supply chain operations.

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)