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.

OpenWorld 2009 in Retrospect

Oracle OpenWorld is over for another year and the streets of San Francisco will be getting back to normal (even after Tuesday's record rainfall). After attending a number of sessions, demos and meetings during the week its worth asking what the 'take away' is for Life Sciences companies.

The first is the growing move of Oracle into the hardware space and Larry Ellison's clear challenge to IBM. IBM has worked closely with Oracle in the past but Oracle's acquisitions in the hardware space has now created a new competitive dynamic. For those at OpenWorld for the technology the promise of Sun and Oracle getting together and this years announcements around Exadata were creating considerable excitement for companies with large data warehouses. For those Life Sciences companies looking to build clinical data warehouses, sales and marketing analytics data marts etc the promise of improved performance at lower cost appeared to be quite compelling.

In the short term there will be considerable opportunities to leverage this in R&D and the promise of extending this to applications databases is also quite compelling. Once the Sun deal receives final regulatory approval it looks like we'll see the new Oracle changing the landscape here.

The other thing on the technology side was the breadth of technology and middleware now available from one vendor (Oracle's demo grounds seem to get bigger every year). There is still a way to go in terms of integrating all of this but Oracle appears to have made a promising start and a number of clients I spoke to were welcoming the move that Oracle is making in at least some (larger) accounts, to help Enterprise Architects navigate their way through this maze of technology.

From my perspective part of that challenge is to put that technology into an appropriate business context and Oracle will almost certainly continue to struggle to field specialists in both the technology and industry expertise. I've certainly known cases where Oracle's own pre-sales people have been aware of Life Sciences functionality that is embedded in some of the technology products (e.g. DICOM support and BLAST searches in the database) and I suspect that's where the focus on Partner Specialization will come into play and partners like Business & Decision will continue to help client's to understand how to plan and deploy appropriate technologies in support of business requirements (see Sunday's Blog).

On the application side it was a chance to see a number of new applications in the Life Sciences industry. This included a number of acquisitions (e.g. Argus from Relsys for pharmacovigilance, the latest PLM acquisitions for pharmaceuticals) as well as new products from Oracle such as Oracle Pedigree and Serialization Manager and industry specific flavors of broader applications e.g. Siebel CRM for Life Sciences.

Industry focus is clearly one key dimension for Oracle and although there will always be more to do (including development work with Partners) Oracle appears to be extending its lead over traditional rival SAP and relative newcomer Microsoft. While there will continue to be best of breed solutions, Oracles ability to integrate via Fusion Middleware and to continue to acquire will see Oracle expand the functional footprint in Life Sciences and other key industries.

On the application front it appears to be evolution rather than revolution and systems integration via middleware was getting a lot of attention. Life Sciences companies with any sort of Oracle Applications footprint will really need to get up to speed with Fusion Middleware if they are looking to integrate and automate business processes.

In summary, OpenWorld 2009 was perhaps a little quieter than last year but there was even more to see and discuss. Despite financial uncertainty over the past year the I world certainly hasn't stood still and Life Sciences companies looking to move forward with projects would certainly have found it an interesting and useful week.

Don't Mention the 'R' Word

Despite some obvious cutbacks in corporate hospitality at the year's OpenWorld (there are rumors that some customers have actually had to buy their own breakfasts!) there seems to have been no mention of the 'R' word - Recession.

This time last year the general feeling was downbeat in the wake of the financial crisis and everyone was waiting to see what the knock-on effect would be on the ecomonomy as a whole. The IT industry (and just about everyone else) then went through a phase of trying to link just about everything to an ability to cut costs, but generally the feeling is now more positive and the consensus seems to be that IT projects are now starting to move forward again.

In Life Sciences we've also seen some discretionary projects being delayed and there has certainly been a focus on consulting rates this year, but the feeling from Regulated Companies I've been speaking to at OpenWorld is that strategic projects are continuing to move ahead. This includes not just projects designed solely at reducing costs but also those looking at improving overall business competitiveness and facilitating business processes which would either not be possible without a degree of automation / integration or would not be cost effective or efficient.

As most companies now seem to have their costs under control (hence more focus on corporate hospitality) the sign is that traditional projects are starting to move forward again in the fourth quarter (ERP, CRM, PLM etc). There is also significant interesting in the use of Fusion Middleware to facilitate business process and systems integration and this is certainly one of Oracle's significant growth areas.

With continued growth being forecast in the Life Sciences industry (albeit low growth in developed countries and significant growth in developing economies such as China) it seems that we're starting to put the recession behind us and look once again to the future.

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.

Labeling and Identification in Life Sciences – A Perfect Storm?

At least a couple of times today I heard the various regulations currently being drafted around the area of product labeling and identification as a ‘Perfect Storm’, driving Life Sciences companies to address these issues.

While Pedigree requirements have been deferred in the US, the US FDA continues to make progress with their UDI initiative that would require unique product identification for medical devices, at least to the level currently required for ethical drugs (requiring the National Drug Code, expiry date and batch number to be included in human and machine readable format) and blood products (where the international ISBT 128 standard is required).

At the same time, the European Union is slowly making progress on the issue of serialization, which is of course already a requirement in many countries for some classes of medical device.

While individual software solutions can help in these areas (see below), the implications of these requirements on Life Sciences companies may be enormous. While many Regulated Companies are seeing this as solely as an IT issue, the reality it is that in some cases complying with these regulations will require significant changes to supply chain models and significant investments in terms of upgrading facilities or even setting up complete new packaging, labeling and distribution centers.

While the business issues are enormous at least some of the software vendors are taking the issue seriously. Here at Oracle OpenWorld there are numerous vendors with labeling and printing solutions, but the most significant news from Oracle is the pending availability of their Oracle Pedigree and Serialization Manager (OPSM), which is set to be at the heart of many serialization and labeling solutions.

OPSM provides the ability to generate and manage serial numbers, interface to ERP and labeling/packaging systems and the ability to submit secure serial numbers to the proposed Government databases . Even better, OPSM is significantly ‘software service’ enabled which means that it is relatively easy to integrate with external systems (it is one of Oracle’s first ‘Fusion Applications’, having been developed on Oracle’s open standards based Fusion Middleware), with the majority of transactions running in the background (generating, tracking and submitting serial numbers, maintaining a database of packaging hierarchies etc).

The use of integrated Fusion Middleware based Business Intelligence means that users in the Life Sciences industry will be able to focus on exceptions (suspect serial numbers, potential counterfeited product, matching and authorizing returns etc) without having to manually interchange data between systems. While other serialization products exist, OPSM has the potential to be at the center of serialization business processes in pharmaceuticals and medical devices, uniquely integrating ERP systems, shop floor packaging and labeling systems and submission to the coming Government databases.

Based on the traffic at the OPSM stand in the OpenWorld exhibition hall there appears to be a good deal of interest in the product - there is certainly a need given current and pending regulations in this area. It will be interesting to see how many Regulated Companies really understand the nature of the coming “Perfect Storm” and translate their interest in OPSM in to real world solutions.

Oracle OpenWorld – Partner Specialization

I'm here in San Francisco at Oracle's OpenWorld event (Sunday 1th to Thursday 1th October).

The big message at the today’s Partner sessions was 'Specialized. Recognized by Oracle. Preferred by Customers.'
This means that under the new Partner program the value of more specialized partners will be more highly valued by Oracle, specialized both in terms of technology and industry.

This is reflecting a broader industry trend in IT as customers and software vendors alike start to really understand the value of specialists in terms of delivering business value, but in the Life Sciences industry the value of suppliers who understand the industry and the specific sector - pharmaceutical, medical device, biotech etc - has largely always been valued.

Oracle, like other major software vendors, is realizing that they can no longer maintain the breadth of technology and industry skills themselves and that they need more specialized Partners to get the best out of their software and deliver successful solutions.

For niche or 'boutique' players like Business & Decision this is good news - with just under 3,000 consultants we cannot compete with the biggest System Integrators - but with our focus on specific solutions within the Life Sciences sector a broader recognition of the value of Specialization is good news.

It should also be good news for prospective clients looking for confirmation that they are selecting the right supplier. When Oracle and other software vendors are really ready to recommend and stand behind specialized Partners (recommending the best and not just the biggest) it should make the job of supplier assessment so much easier.

Infrastructure Qualification White Paper Updated

Following the finalization of the GAMP "A Risk-Based Approach to Operation of GxP Computerized Systems" good practice guide we decided to update our "Pragmatic Infrastructure Qualification" white paper (available on the Business & Decision Life Sciences website).

Although originally written in 2005 the white paper had stood the test of time well - what we were promoting as industry leading best practice back then has now been adopted in the new GAMP good practice guide or in version 5 of the GAMP Guide. It just goes to show how best practice changes to become more widespread good practice over time.

Some of the regulatory references had become a bit dated and we're now also able to reference almost five years operation of own qualified Data Center where we host and manage client's regulatory significant applications (ERP, LIMS, Change Management etc) on our qualified infrastructure.

Although infrastructure qualification isn't quite the 'hot button' topic it was in the middle of the decade it's still something that needs to be addressed - the more cost effectively the better.

Over the coming months we're going to be running a series of webcasts to share some of this best practice with a wider audience and there are also plans to develop a new white paper looking at applying some of this best practice to new technologies such as virtualization and middleware and Service Oriented Architecture.

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.

China - Here We Come

After a lengthy sales cycle Business & Decision Life Sciences have just closed our first compliance and validation deal in China - to retrospectively and prospectively validate a number of ERP systems for one of the largest state owned pharmaceutical companies in China.

The interesting part is that this is not only driven by a desire to export products to overseas markets such as the US (and not just APIs, but also finished pharmaceuticals), but this is also being driven in part by the Chinese State Food and Drug Administration (SFDA) looking to assure the safety of products in their own local market.

While it is understandable that commercial objectives drive the need to meet US and European regulatory expectations in the export market, the SFDA requiring the validation of computerized systems used in the distribution of pharmaceutical products appears to be a positive sign with respect to improving overall product quality and tackling the issues associated with counterfeiting and supply chain fraud which is a significant problem in China.

We'll be engaging with the client with a mix of local computer system validation experts from our Business & Decision office in Beijing as well as ERP validation experts from the U.K. and U.S. It certainly looks like a very interesting project from a number of perspectives and it will be interesting to see how seriously the Chinese government and local manufactures are taking cGMP and GDP.

Latest Validation Newlsetter now Online

The lastest copy of Business & Decision's "ValidIT" IS Compliance and Validation newsletter is now available to download from our website.

Contents inlcude an update on Eudralex Volume 4 Annex 11, updates to the FDA Warning Letter process and a selection of questions and answers addressed by our compliance and validation consultants.

You can access and download a copy from here.