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January 20, 2010

GxP Compliant Learning Management System – Is that what you’re looking for?

In choosing a Learning Management solution out of the several befitting the other business requirements and constraints, one question that is generally tossed up, particularly by customers in the more regulated industries such as life sciences, healthcare, medical device manufacturing, biotechnology, is – whether a product / system under consideration is compliant with FDA 21 CFR Part 11 (the standards mandated by FDA to set a product apart as GxP ("Good Practices") compliant, and standards for electronic records). Oftentimes, the onus of delivering a regulatory compliant system is put on the software vendor.

The software vendor indeed has the responsibility to provide all necessary technology features to support CFR compliance. These technology features should cover capabilities like audit trails (e.g. maintaining transaction history tables), systemic management of revision-sensitive information (e.g. notifying and scheduling learners for retraining as effected by procedure revisions or just due timing), auto-generation of training plans for learners depending upon role requirements, maintaining electronic records by enforcing e-Signatures, user authentication and authorization, etc. However, one other aspect that deserves due diligence is the role of the user organization in ensuring compliance.

Regulatory compliance by the software is not just an additional ‘functionality’ offered by the system (which it is sometimes mistaken as), but more like developing a process framework (of course, backed by technology infrastructure) dedicated to meeting the intent of the regulation. Essentially, achieving a truly GxP compliant software system requires procedural and administrative intervention (including, but not limited to, trainings, notifications, SOPs, administration and reporting of electronic records) as much as it requires technical capabilities on the part of the software itself.

While building up these technical capabilities falls in the purview of the software vendor, the other mentioned aspects need a robust and scalable approach towards organizational readiness and change management, which, to many organizations, can at best be addressed by a partnering organization who can undertake the entire responsibility from defining process framework to systems integration to software validation to effective change management, leveraging technology capabilities as enabler to deliver a GxP compliant system in its true essence.
Also, while many off-the-shelf software products come as ‘validated’ for regulatory compliance, I’d think it’s very essential for the customer organization to run with a comprehensive validation phase as part of the implementation lifecycle before the software is deemed ready to be adopted into the company’s process and technology stack. Would you agree?
 

January 19, 2010

A holistic and integrated OR solution is a powerful differentiator

People-related issues are consistently cited as one of the primary challenges to the success of major technology-based initiatives.

Organizational Readiness’ (OR) goal is to integrate the “people” component of transformation with the “process” and “technology” components to ensure a successful business transformation endeavor. 

 

Change Management, Learning and Communication components of ERP implementations form a “three-legged stool,” and no one component can stand without the others.  The interconnected and cross-leveraged deliverables of change, learning, and communications only underscore the necessity for broad thinking about organizational readiness. Here are four examples to illustrate this:

Example 1: Leaders may underestimate the challenge of implementing ERP, viewing it as just another package. Some stakeholders may see little value in adopting the new system or overlook its profound effect on their organization. It is the job of change management to educate the leadership as a first step during the project, such that sufficient funds, organizational recourses and time is allocated to learning activities and building the right capabilities for sustaining it.

Example 2: An early step in change management is assessing the organization’s readiness for adopting and assimilating the change. Two of the key factors measured are individuals’ perceptions about learning activities within their organization, and their attitudes towards learning to use new systems. The output from these drive the communications about learning, as well as the pace and blend of the learning program.

Example 3: An ‘organizational impact assessment’ is typically carried out during the Design stage by the change management team, its goal is to determine the job impacts resulting from the new processes and procedures, as well as the interventions required to support the transition of the workforce. These interventions typically include management action plans that must be stewarded by the change management team, as well as communications and learning goals for the affected job roles, that will eventually shape the learning curriculum.

Example 4: Finally; any ERP trainer who has been through the experience of trying to deliver a class to individuals who do not understand the need for the transformation, or how it is impacting their organization and jobs; knows that appropriate and timely change communication is an important prerequisite for any systems training activity.

The leading organizations who understand the importance of the people aspects of business transformation, profoundly appreciate the value of an integrated approach to change, communications and learning by their vendor partners. This provides a golden opportunity to differentiate from the rest of the flock, for the few consulting firms who have the breadth and scale to provide these services under one roof, to go to the market and present their Org. Readiness offerings as integrated and holistic solutions, rather than a set of competing or incompatible add-ons.

January 13, 2010

Can competitive edge be sustained without effective Talent Management?

Intriguing as it may sound; thought to bring this question forward for discussion, for it may after all seem as difficult to answer as it may to distance from. Many would agree that most of the high-performing organizations have engaged themselves with strategic talent planning and management over a period of time during the course of their journey, to reach where they today are.

The question, however, is, whether an organization can achieve, and more importantly, sustain, a high-growth trajectory and competitive edge without a coherent talent management strategy? Unless a whole-hearted ‘yes’ is an answer to this question (which, I think, is less likely), there ought to be a correlation (even quantifiable, within the company’s ecosystem) between talent management and sustainable growth..

What do you think?

January 11, 2010

Cloud based Enterprise Applications: Does it need a new approach to end user adoption?

There has been a significant movement in the development of key enterprise applications (CRM, HCM) on the cloud. With on-demand infrastructure available, the value proposition to move enterprise applications to the cloud is becoming more and more promising. I do not believe this trend is going to slow down, in fact the adoption of SaaS (Sofware As A Service) is only going to see an increase. As we all know, a key value propositions of such applications is decreased “time to market”.

In other words, enterprise software deployed, configured to specific business requirements and made available to end users in a shorter period of time. But in the end, true value (ROI to the business) from any application is realized once there is “meaningful use” of the application by its end users.

In my opinion this does pose a significant challenge for end user adoption. Organizations need to ensure that user population is ready to use the application in a shorter period of time due to shorter implementation cycles. Hence, I think such scenarios would mandate end user adoption strategies to be quite different from current methods applied to traditional ERP implementations, which runs for 12-18 months. The time horizon to create awareness of the change, build the right skills and prepare the users for the new business processes and workflows is relatively short.  

Do you believe that a new approach is required for such scenarios leading to “meaningful use” of cloud based applications?

 

Choosing the right hosting model for Learning Technology Infrastructure?

The choice of deployment or delivery model (to deploy/host the hardware and software) is one of the firsts to ponder upon while undertaking a Technology Infrastructure project for L&D. Not a straightforward decision anyway, the perplexity might just have been enhanced by the availability of diverse options (we’ll talk about them in a bit) available to the customers.

A company, while investing in the technology infrastructure, must look for a robust, scalable and cost-effective solution that offers the highest degree of availability, reliability and integrity, and befitting the business requirements and information security & business continuity commitments of the organization. The choice of the deployment/hosting model should take all these factors into equated consideration, right?

The choice of the hosting model usually needs to be made from the following listed options, and should be contingent upon a careful analysis of several factors:

1.       Perpetual license based (internal hosting) – where a customer buys the perpetual licenses for the software and procures the hardware to deploy the solution in own premises (own network, behind the firewall)

2.       External (third-party) hosting – where a customer buys the software licenses, however, delegating the deployment and operation to a third-party by paying regular fees for operation, upgrade and support

3.       On-Demand Software (SaaS) – where a customer does not buy a software solution, instead, rents it from the provider. The provider hosts, maintains and supports the solution, and charges the customer for the use of an instance of the software tailored according to some specific needs of the customer

From a cost perspective, the On-Demand (SaaS) hosting model stands apart, as it involves neither the cost of license perpetuity, nor does it require any expenses on maintenance, upgrade and support of the deployed solution. It does incur a monthly fee (contingent upon usage) to be paid to the service provider; this usually is much lesser when compared to the entry cost and operating cost involved with the other two options.

Given the above, the On-Demand hosting model makes a pretty compelling proposition for most Learning Technology implementations. Then, why are we not seeing a significant surge in the number of companies (especially large enterprises) opting for this model?                                                                     

Is leveraging the in-house IT capabilities and integration with org’s business processes, the reason; or perhaps a long-term view towards IT consolidation? Or, is it the lack of confidence in shifting the sensitive assets like PII (Personally Identifiable Information) outside the company’s firewall; or perhaps the fact that most Learning Management implementations are complex enough to require customizations that are beyond the scope of what configurable, On-Demand instances can support? Of course, there’s no one-size-fits-all reasoning, and a lot depends on organization’s priorities and readiness, but are there any which you would call as the primary drivers?

And, what kind of shift, if any, do you foresee in the trend (especially for (global) enterprises) going forward?

January 07, 2010

Are we finally going to train first-line managers again?

I was just looking at the new Bersin report, "Enterprise Learning and Talent Management 2010: Predictions for the Coming Year".  Number 3 out of 12 made my heart leap, "High-impact leadership development programs will focus on first-line management".  Are we finally going to train first-line managers again?

 

Ok, I know I am dating myself here, but my first management job was with IBM in 1987.  I was immediately shipped off to a one week new manager class where we were drilled on everything from "how to keep the monkey off our back" (or how to properly delegate) to "how to deal with inappropriate employe behavior/attire" (my practice case was to talk to a male employee who was wearing pants that were too tight), to "how to create and give performance appraisals".  We came home with a huge manager's manual that addressed all kinds of policy and personnel issues.

IBM knew then (and now) that first line managers drive the organization.  Most employees quit, not because of a company, but because of a manager.  Most lawsuits from employees are due to misconduct by the first line manager.  Yet, in the last few years, many companies have dropped formal new management training programs and assume that new managers know:

  1. What they are responsible for
  2. What they are authorized to do/not do
  3. How to effectively be a good manager

Unfortunatly, they are wrong!  Bersin says, "In 2010, organizations must rethink their leadership development investments--and take the time, money, and resources to re-build first-line management programs".

All I can say is, "hear, hear!"

Karen

January 04, 2010

Proactive management of L&D / enabling processes

Business cycles across economies and industries are recurring, posing newer challenges along each turn for every organization. While every organization strives to achieve and sustain success in its core business processes (more the better), the ‘enabling’ (non-core) business processes sometimes tend to lag behind the organization’s overall growth trajectory. While many organizations have emerged as leaders and visionaries in their core business by doctoring this problem of ‘enabling processes lagging behind’ and giving due diligence to the relevant enabling processes (e.g., learning & development, talent management, the entire human capital management realm) and empowering their most important assets (read people!), there are other who are yet to take the leap. Staying ahead of the curve and ensuring the growth of enabling processes goes hand-in-hand with the growth of the core business are the real challenges, and that’s what makes the differentiating strategic moves of an organization towards its business objectives so pivotal!

How does an organization stay ahead of this curve?  An organization adopts processes, technology and infrastructure depending upon a number of factors (lifecycle stage, number and nature of core business processes, size, geographies, etc. etc.). [Think start-up > mid-market > enterprise > global enterprise…). While the core business processes could be more long-term propositions, most companies usually leverage advancement in enabling (non-core) processes on a comparatively shorter-term basis. The real challenge for most companies, however, is to adjudge the right time to shift gears in the management of enabling processes. And this, in my opinion, stands as one of the key differentiators. Would you agree?

Oftentimes, we come across organizations seeking learning, development & talent management solutions for the primary reason that their businesses have outgrown their current processes, infrastructure and technology. While from the outset, the time when this realization is made looks like an ideal moment to revive processes/technology, one thought that I’ve often found intriguing is – what if an organization is more proactive in terms of anticipating the need for change, and taking steps ahead of time, rather than allowing this problem of ‘enabling processes lagging behind’ to do the damage before any corrective action is taken. Like, why would anyone want the sales volumes to decline for a few quarters before realizing the gaps in sales force training on the new products/services, or a few compliance glitches due to lack of robust reporting mechanism as the root cause behind the trend.

Well, one way of justifying this approach could be that the company has all the reasons to dedicate all the resources (time, energy, money, people) on core processes (design, production ‘et al); but then again, the counter argument could be that this doesn’t need to come at the cost of a better trained workforce. As a matter of fact, the efforts on core processes will yield the best results only by effectively cascading the relevant knowledge to all levels, both internally and externally. What is your opinion?

Indeed, there are organizations that take a long-term view of their learning processes and technology infrastructure; may be because they understand the significance of enabling their core processes and the stakeholders involved therein with the best-in-class knowledge at any time and place it is required. For these organizations, to my mind, the lifecycle curve of these enabling processes follows the growth trajectory of the organization’s core business. Many would agree that these organizations are in a better position to respond to fluctuations in business ecosystem, and are backed by robust and scalable pipeline of talent and the processes to sustain them. Have you experienced any such case that you’d like to share?

Having a robust framework with a long-term view of enabling processes, rather than having to go back to the drawing board just about every time a problem pops up, has its own incentives even in the shorter term. It helps in sustaining an empowered and motivated workforce at all times and brings about a cultural shift towards being a learning organization, thereby lending that much needed thrust to the organization’s performance and productivity metrics. All the more, it helps in achieving this state with minimum investment of time and money as compared to otherwise, thereby reducing the opportunity cost and boosting the ROI metrics.  After all, it’s not too difficult (not intimidating either  :) ) to keep apt focus on these enabling processes that are so fundamental to the growth and development of a company’s workforce, without compromising on the attention and resources that the core business processes demand.

Having said that, the natural question that comes to mind is - what can lead an organization ahead of the curve as far as management of these enabling processes? To my mind, a company’s process and technology owners should always be ready with answers to these questions (by leveraging expertise from outside the company, if necessary) to be able to plan and be ahead of the curve: (would you like to add to this list as you read through?)

1.       Alignment of enabling processes with business goals - Whether the systems and processes aligned with the short-term, medium-term and long-term business goals of the organization? What efforts are being (should be?) made to fill the gaps, if any?

2.       Scalability Assessment – What user base (in terms of volume, demographics, Key Responsibility Areas, etc.) can be supported by these processes and infrastructure in their current shape and form, without compromising on efficiency?

3.       Operational support - Are the current systems and processes capable of supporting the HR organization so they can focus on the strategic issues and initiatives, rather than being caught up in the nitty-gritty of operational nature?

4.       Be proactive - Last, but not least, the above three should be anticipated and acknowledged proactively, and responses to them should be aligned well with the business cycles.