Leveraging Agile Methods - Some Key Questions

I'm here in Vienna speaking at the IIR Conference on Computer System Validation. Today I'm speaking on the topic of Alternative Software Development Lifecycles (registered subscribers to the Business & Decision Client Hub can access copies of the slides via the Client Hub login pages - follow the links to 'Webcasts').

During the questions and answers session there were some really good questions raised / observations made.

The first was concerning the acceptability of Agile methods as far as the regulatory agencies are concerned. This is probably more acceptable from the perspective of the FDA, because their General Principles of Software Validation doesn't reference any specific lifecycle and leverages good software development practices. Of more concern are PIC/S inspectors, because the PI011-3 guidance document specifically references GAMP 4 and includes the old GAMP 4 'V' model, with no plans to update this guidance.

When asked I replied that the best way to handle the issue of regulatory inspectors who aren't experts in computer system validation and software development is to use the Validation (Master) Plan to:

• Reference relevant regulatory or industry guidance (e.g. FDA guidelines or GAMP 5)
• Clearly define (or reference) the SDLC that is being used and how the project controls and software quality activities meet regulatory expectations (which means careful project-by-project planning)

Of course, it's also important to demonstrate that the project did what they were supposed to do (see the slides for details)

The second point was around more frequent, smaller software releases, using techniques such as time-boxing. The point being made was that although you may get to initial software release (and ROI) faster, this also means that you need to plan on doing important activities such as preparing operational and maintenance processes / SOPs, performing user training etc earlier than might have been the case following a more traditional SDLC.

The final interesting question was around the extent of the change control impact assessment, risk assessment and regression analysis. These are even more important with more frequent software releases and the conclusion was that this burden would probably be higher using 'Agile' techniques. However, in most cases where Agile techniques are applicable the burden of impact assessment, risk assessment and regression analysis should be more than offset by the advantages to the business in terms of faster ROI, lower development costs and delivering better functionality.

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.

Coming Soon! PhUSE 2009 in Basel, Switzerland

For those who don't know, PhUSE is the "Pharmaceutical Users Software Exchange". PhUSE is an independent non-profit organisation run by volunteers.

Its purpose is to create a European forum for programmers in the pharmaceutical industry by way of a society that holds several events per year (including hosting an annual multiple day conference) as well as providing a library of learning tools.

Given the support of the major European pharmaceutical companies, PhUSE is the premier event for Pharmaceutical Programmers in Europe and is now entering its fifth year.

The 2009 conference will be held in Basel Switzerland between the 19th - 21st October.

Business & Decision actively support and participate in a number of industry groups such as PhUSE and this year I will be presenting a paper in the "Applications and Software Development" section, on Wednesday 21st at 13:00.

The subject of the presentation is "Compliant Agile Development", where we discuss how Agile software development techniques can be applied within a controlled framework that is suitable for the regulated Life Sciences industries.
The presentation will actually feature 2 papers;
I will be co-presenting with my colleague, Christopher Cieslok, on Business & Decision's tailored framework for Agile techniques within Life Sciences, while Prof. Dr. Eckhart Hanser, our collaborator from the University of Cooperative Education in Lörrach, Germany, will be presenting a more general paper on his research into team self-organisation and other meta-elements of Agile projects.

I will share some of the core elements we will present at PhUSE after the conference, and also discuss more on Agile techniques for compliant software development and the issues we face in this area in future posts.