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Just Other Articles - Two Critical Success Factors in an ITIL Implementation
Any IT manager who wants to pursue the IT Service Management journey by implementing the Information Technology Infrastructure Library (ITIL) needs to understand two very important factors well in advanc
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
e.
• The first factor is to have dedicated, trained and committed process owners.
If you want to have a successful Incident Management process which is under continuous improvement, you will need someb
• The first factor is to have dedicated, trained and committed process owners.
If you want to have a successful Incident Management process which is under continuous improvement, you will need someb
; 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
ody who is ultimately responsible for it’s success and who can dedicate the time and focus to drive it and to make sure it actually happens. A lot of organizations makes one of the following mistakes:
•
•
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
The process owner is non-existent which means there is nobody dedicated to drive a particular process.
There is a process owner, but he or she is bogged down in day to day reactive activities or other
There is a process owner, but he or she is bogged down in day to day reactive activities or other
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
"more important" business-driven projects and thus have no time for unnecessary "red tape" like ITIL.
• There is more than one process owner for a particular process - a classic mistake. The idea of ITI
• There is more than one process owner for a particular process - a classic mistake. The idea of ITI
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
L is to have a single consistent process throughout the organization and having two head cooks in this "process kitchen" is sure to mess up the cake. Who will ultimately be responsible if there is more t
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
han one owner? Major companies who have successfully implemented ITIL have only one process owner throughout the company, even if there are numerous divisions spread across the globe. This ensures that t
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
he process is consistent throughout all divisions and helps the break down barriers between departments and divisions.
The primary problem here, is that companies do not want to spend the money on dedic
The primary problem here, is that companies do not want to spend the money on dedic
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ate resources for process owners. Obviously a process owner can have a split role, doing other work as well, especially in smaller companies. As long as that other role is not of a reactive firefighting
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
nature. One person can also be made responsible for more than one process. Although these processes should be of similar focus. The Change, Configuration and Release roles can be shared by one person in
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
small companies for example. I believe in a large corporate these roles should be fulfilled by dedicated people, and companies who does not fill these roles are not serious enough about ITIL and is most
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
probably lacking the management commitment.
Which brings us to the second, but probably the most important critical success factor, namely management commitment?
If you are responsible for an ITIL impl
Which brings us to the second, but probably the most important critical success factor, namely management commitment?
If you are responsible for an ITIL impl
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
ementation, make sure you have commitment from the top; otherwise ITIL might just become another failed IT project throwing time and money down the drain.
And management commitment does not mean, "the m
And management commitment does not mean, "the m
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
anager says his committed". The manager must walk and talk ITIL and continuously show his commitment.
In practical terms this means empowering staff through professional training, tools etc., appointing
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
the right people in the right roles and managing by means of ITIL, e.g. demanding the right reports and taking action...
Kotter's 8 steps to organizational change is actually a good guideline for top m
Kotter's 8 steps to organizational change is actually a good guideline for top m
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
anagement to follow.
Management commitment is probably the most important success factor for ITIL, but in my experience, probably also the most difficult to find. That is why a lot of ITIL implementatio
Management commitment is probably the most important success factor for ITIL, but in my experience, probably also the most difficult to find. That is why a lot of ITIL implementatio
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
ns just become a black hole sucking up money.
I think there are a lot of IT managers that is under this misconception, that ITIL is a silver bullet to fix all their problems. Just install ITIL (almost l
I think there are a lot of IT managers that is under this misconception, that ITIL is a silver bullet to fix all their problems. Just install ITIL (almost l
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ike installing a new technology) and everything will be OK. What they do not understand is that ITIL is a major organizational change, including a culture change. We used to focus only on technology, bu
.
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
t now we have to focus on the customer.
Another reason for low management commitment is also that ITIL is usually an internal IT department endeavor and not a direct requirement from the business. ITIL
Another reason for low management commitment is also that ITIL is usually an internal IT department endeavor and not a direct requirement from the business. ITIL
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
is a methodology for improving IT and not as such the business.
To overcome this, an ITIL project should become a business requirement and commitment is needed from all the way to the top, from the CEO.
To overcome this, an ITIL project should become a business requirement and commitment is needed from all the way to the top, from the CEO.
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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