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Digg It - Leaping Asset Management Hurdles
I attended ECPweb's Software and Asset Management Summit '04 at The University of Chicago to deliver a workshop on software auditing and compliance. It was a great opportunity for me to talk with other industry professionals as well as to speak with IT and asset managers tasked with implementing asset management (AM) and compliance programs.
As I reflect bac
As I reflect bac
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
k on my conversations, I realize that certain hurdles to achieving AM program success are common in just about every company, regardless of size. I spoke with folks from organizations trying to manage 100,000+ IT assets, as well as with those who were trying to manage just a few hundred assets.
The problems are the same everywhere, only the scale changes. I
The problems are the same everywhere, only the scale changes. I
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
probably said a hundred times, "You are not alone; most companies have the same problems!" To summarize the issues, I've identified the following key problem areas:
· There is inadequate senior-level visibility, involvement and commitment to the project. Ouch! Not good.
· There are no internal subject matter experts, the task is overwhelming, and there are
· There is inadequate senior-level visibility, involvement and commitment to the project. Ouch! Not good.
· There are no internal subject matter experts, the task is overwhelming, and there are
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
oo few external experts, road maps or models for reference. A general lack of understanding of the pertinent regulatory and compliance issues further complicates an already daunting challenge. With an estimated 10,000 regulations and laws surrounding IT, this is certainly understandable.
· Internal silos and conflicts between key departments (finance, IT, pu
· Internal silos and conflicts between key departments (finance, IT, pu
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
rchasing and contract management) primarily surrounding functional and reporting needs can grind a project to a complete standstill. There also may be multiple isolated pockets of asset management already in place at varying levels of maturity.
· Most IT and asset managers are unable to present appropriate business cases to support the need for enterprise-wi
· Most IT and asset managers are unable to present appropriate business cases to support the need for enterprise-wi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e management of IT assets. Without a solid business case, requisite funding can be illusive!
Since these issues are universal, a closer look at how some organizations have overcome these obstacles may help to ensure success for your own IT compliance and asset management project.
In 2003 Aberdeen Group conducted a study of 252 businesses on enterprise asset
Since these issues are universal, a closer look at how some organizations have overcome these obstacles may help to ensure success for your own IT compliance and asset management project.
In 2003 Aberdeen Group conducted a study of 252 businesses on enterprise asset
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
management (EAM) programs. Results from the study show initiatives that realize the highest return on investments (ROI) include: involvement from senior financial executives, successful breakdown of AM silos, and provisioning to the enterprise ample and strategic AM coverage.
Great, now that and a nickel still won?t buy me a cup of coffee! So, let's break i
Great, now that and a nickel still won?t buy me a cup of coffee! So, let's break i
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
t down further. This first step to initiating an AM project is to define the goals the company hopes to achieve from the project.
A straightforward way to perk up executive ears is to align the goals of the project with the corporate mission statement and overall corporate goals. Use as much of the same language as possible in your pitch and the project goal
A straightforward way to perk up executive ears is to align the goals of the project with the corporate mission statement and overall corporate goals. Use as much of the same language as possible in your pitch and the project goal
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
statement. You may be laughing at this idea, but it's hard to object to a project aimed squarely at achieving goals the Board of Directors has already bought into.
If that doesn't get "C-level" buy-in, a list of cost-avoidance and risk-reduction statements can usually help. Remind management that the austere corporate performance and accountability regulati
If that doesn't get "C-level" buy-in, a list of cost-avoidance and risk-reduction statements can usually help. Remind management that the austere corporate performance and accountability regulati
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ons today require policies, procedures and effective tools to maintain adequate controls for financial reporting. If you need to spell it out more clearly, here are the letters: E-N-R-O-N!
The list of project goals should also include intangibles such as improved IT service levels and reduction in risk factors "often difficult to plug in to traditional ROI m
The list of project goals should also include intangibles such as improved IT service levels and reduction in risk factors "often difficult to plug in to traditional ROI m
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
dels. Don't give up; there are ways to illustrate soft benefits!
Use examples of historical situations to help sell the point. For example: "Last month the company was hit with the 'nasty-code' virus. It took three hours to patch and recover our most critical systems. During that three-hour window our 50 'business critical' users were unable to work (that ad
Use examples of historical situations to help sell the point. For example: "Last month the company was hit with the 'nasty-code' virus. It took three hours to patch and recover our most critical systems. During that three-hour window our 50 'business critical' users were unable to work (that ad
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ds up to 150 man-hours). It took three IT resources to resolve the problem." Let's assume each employee earns $50 per hour.
" That equates to $7,950 in lost salary, not to mention the business we lost due to downtime. Our IT staff still has scheduled work to perform that may require overtime to complete." Now put the icing on the cake "return to your histori
" That equates to $7,950 in lost salary, not to mention the business we lost due to downtime. Our IT staff still has scheduled work to perform that may require overtime to complete." Now put the icing on the cake "return to your histori
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
cal, indisputable data: 'That was the fifth virus incident in five months.'"
Suddenly the intangible becomes tangible. "If this cycle continues, we will waste close to a $100K this year on reactive virus management and still will not have the tools needed to proactively manage our assets." It is always good to include cost-avoidance metrics when requesting b
Suddenly the intangible becomes tangible. "If this cycle continues, we will waste close to a $100K this year on reactive virus management and still will not have the tools needed to proactively manage our assets." It is always good to include cost-avoidance metrics when requesting b
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
dget approval and soliciting corporate buy-in.
Leverage the company's internal financial experts to help illustrate other examples of ROI. These areas include optimization of vendor contracts, improvements in forecasting and budgeting, and increased efficiencies for both IT and end users.
IDC reported that downtime can be reduced by 10%, and person-hours on
Leverage the company's internal financial experts to help illustrate other examples of ROI. These areas include optimization of vendor contracts, improvements in forecasting and budgeting, and increased efficiencies for both IT and end users.
IDC reported that downtime can be reduced by 10%, and person-hours on
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
recovery can be reduced by 22% for businesses that practice good asset management. Good AM can reduce an average help desk call by 25%. Getting staff back to work quickly and keeping them working efficiently is critical to the success of most organizations.
Consider how business processes will improve when finance, procurement, IT and asset managers can tak
Consider how business processes will improve when finance, procurement, IT and asset managers can tak
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
advantage of cross-functional collaboration. Disparate pockets of incomplete, outdated and possibly inaccurate asset data undermine an organization's ability to improve asset utilization. With electronic enterprise-wide IT asset management, improvements are inevitable in the areas of: forecasting, budgeting and procurement; software license compliance; maint
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
enance planning; and overall PC life-cycle planning. Improved asset utilization is a key component to sustained corporate growth.
Help non-technical staff understand the value they will derive from dynamic, structured and actionable information as opposed to what can be gleaned from seven thousand lines of static data in a Microsoft® Excel spreadsheet! Remem
Help non-technical staff understand the value they will derive from dynamic, structured and actionable information as opposed to what can be gleaned from seven thousand lines of static data in a Microsoft® Excel spreadsheet! Remem
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ber the difference between data and information? Humans can make decisions based on information; raw data is best left for computer systems to deal with!
Develop an internal team to help define the program and to shape the list of business needs and benefits. The team must include key players from each department or business group that plays a role in the li
Develop an internal team to help define the program and to shape the list of business needs and benefits. The team must include key players from each department or business group that plays a role in the li
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
e-cycle of IT assets (from cradle to grave).
The team must define appropriate processes to facilitate the company's AM strategy; don't count on an asset management tool to provide the process or you are doomed to fail. As the underlying process is defined, make sure to define roles and responsibilities for each step of the process and also for each phase of
The team must define appropriate processes to facilitate the company's AM strategy; don't count on an asset management tool to provide the process or you are doomed to fail. As the underlying process is defined, make sure to define roles and responsibilities for each step of the process and also for each phase of
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
the project.
I've listed the hurdles to a successful AM or compliance program as well as advice on overcoming those obstacles. You may be thinking, "Sure, but it isn't going to be easy." Sorry, I never said it would be easy, just achievable! Don't go it alone, put the burden of success squarely on the shoulders of the project team and senior-level management
I've listed the hurdles to a successful AM or compliance program as well as advice on overcoming those obstacles. You may be thinking, "Sure, but it isn't going to be easy." Sorry, I never said it would be easy, just achievable! Don't go it alone, put the burden of success squarely on the shoulders of the project team and senior-level management
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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