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Social Space - What is ITIL? (And - More Importantly - What It Isn't!)
As a qualified and experienced ITIL Consultant - I'd like to set the record straight on a few points.
The IT Infrastructure Library (ITIL) is an excellent set of best practices, carefully organized and edited to provide readers with information and structure for how to plan, implement, maintain
The IT Infrastructure Library (ITIL) is an excellent set of best practices, carefully organized and edited to provide readers with information and structure for how to plan, implement, maintain
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
and improve the service delivered to an organizations customers.
ITIL is owned by the Office of Government Commerce (OGC) and is copyright and trademark protected. The IT Service Management Forum (itSMF) is the leading, independent, not for profit, organization that is owned and run by it’s worl
ITIL is owned by the Office of Government Commerce (OGC) and is copyright and trademark protected. The IT Service Management Forum (itSMF) is the leading, independent, not for profit, organization that is owned and run by it’s worl
; 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
wide members – to promote and exploit the benfits of ITIL.
Oftentimes, when people first read one of the core ITIL books; ITIL is always classed as ‘common sense’ particularly by so called practitioners that say to themselves, "yeah, we do that already – so what?"
Well guess what. It IS common
Oftentimes, when people first read one of the core ITIL books; ITIL is always classed as ‘common sense’ particularly by so called practitioners that say to themselves, "yeah, we do that already – so what?"
Well guess what. It IS common
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
sense - but unfortunately it is found all to UNCOMMONLY.
At the heart of ITIL are a set of processes and procedures that any organization can review, customize and configure to their own content. These have been written and enhanced over 15 years from a variety of ITIL/Service/Process experts. T
At the heart of ITIL are a set of processes and procedures that any organization can review, customize and configure to their own content. These have been written and enhanced over 15 years from a variety of ITIL/Service/Process experts. T
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
is is the whole point of ITIL – it’s a best practice starting point – to be considered, re-worked and carefully implemented into an organization to match that businesses needs. No verbatum, to-the-letter-of-the-book, style implementation will ultimately be more than 50% effective for any organiza
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tion. Every place is different. Every Business is different. Every customer is different.
Over the last ten years, many thousands of IT Service professionals have provided feedback and helped to enhance the core OGC ITIL texts - so you can rest assured that it is THE #1 place to start when imple
Over the last ten years, many thousands of IT Service professionals have provided feedback and helped to enhance the core OGC ITIL texts - so you can rest assured that it is THE #1 place to start when imple
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
enting strategic IT Service Management.
Moreover, recently, ISO20000 has been ‘fast tracked’ through the International Standards Committee to become the worldwide standard for IT Service Management. A lot of ISO20000 requires key aspects of ITIL to be implemented, namely IT Service Support and I
Moreover, recently, ISO20000 has been ‘fast tracked’ through the International Standards Committee to become the worldwide standard for IT Service Management. A lot of ISO20000 requires key aspects of ITIL to be implemented, namely IT Service Support and 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 Service Delivery processes. Note: ISO20000 does NOT specify that ITIL is a pre-requisite for certification – but it is the logical starting place for best practice adoption.
A few home truths about ITIL - having observed its implementation in various guises into many clients over the last 10 y
A few home truths about ITIL - having observed its implementation in various guises into many clients over the last 10 y
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ars:-
- It requires investment in time, effort and people’s energy – therefore there’s a cost
- It requires capable and experienced people – people who are ITIL foundation and ITIL managers certified
- It requires a transformation programme to own and guide the effort of many smaller,
- It requires investment in time, effort and people’s energy – therefore there’s a cost
- It requires capable and experienced people – people who are ITIL foundation and ITIL managers certified
- It requires a transformation programme to own and guide the effort of many smaller,
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
but still significant projects.
- It requires active, senior buy-in. No buy-in – no ITIL. It’s that harsh.
- It therefore requires to be understood at a senior level and therefore the ROI in ITIL must be deliberately planned and realized
- It's ‘transformational’ change - so that
- It requires active, senior buy-in. No buy-in – no ITIL. It’s that harsh.
- It therefore requires to be understood at a senior level and therefore the ROI in ITIL must be deliberately planned and realized
- It's ‘transformational’ change - so that
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
means people change roles; people have new ways of working and communicating; the organization begins to hardwire the voice of the customer into the heart of IT/Technology
Some further considerations:-
- It's tough to do; people play politics with their empires; people protect their functional
Some further considerations:-
- It's tough to do; people play politics with their empires; people protect their functional
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
silo's; people resist change
- It takes time; to plan, to design, to build, to test; to 'DO'
Essentially you have to change the 'planes engine whilst the 'plane is still in flight - meaning – YOU have to transform the way Technology delivers service - without impacting the quality and availabil
- It takes time; to plan, to design, to build, to test; to 'DO'
Essentially you have to change the 'planes engine whilst the 'plane is still in flight - meaning – YOU have to transform the way Technology delivers service - without impacting the quality and availabil
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
ty of Service.
ITIL's all about Service. Not Tools. Not Technology. Not Process. In my opinion, they are just by-products of what the end goal is.
[Incidently - there's NO such thing as an ITIL compliant tool. ITIL is a set of best practices - not a 'standard' that can be complied to. Vendors a
ITIL's all about Service. Not Tools. Not Technology. Not Process. In my opinion, they are just by-products of what the end goal is.
[Incidently - there's NO such thing as an ITIL compliant tool. ITIL is a set of best practices - not a 'standard' that can be complied to. Vendors a
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
lways incorrectly say their tool is 'compliant'. Gartner agrees with me on this.]
ITIL makes you think deeply about who's doing what, when, how, with what tools, how well are they doing, could they do better, how does the customer perceive us... these are just some of the constant questions that
ITIL makes you think deeply about who's doing what, when, how, with what tools, how well are they doing, could they do better, how does the customer perceive us... these are just some of the constant questions that
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
are raised EVERYDAY when you are implementing and running an ITIL based Organization.
These are the RIGHT questions for IT Service Success!!
The benefits of ITIL are many - but here are a few of commonly reported ones: -
- ITIL breaks down functional silo's, gets people and information flowing
These are the RIGHT questions for IT Service Success!!
The benefits of ITIL are many - but here are a few of commonly reported ones: -
- ITIL breaks down functional silo's, gets people and information flowing
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
; gets people talking; all for the benefit of the Customer (service recipient).
- ITIL helps to re-organize IT/Technology to be Customer focussed. The roles, responsibilities, information and reporting requirements all converge to push meaningful and timely information towards the right Customer
- ITIL helps to re-organize IT/Technology to be Customer focussed. The roles, responsibilities, information and reporting requirements all converge to push meaningful and timely information towards the right Customer
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
interfaces.
- ITIL makes people think from a Service perspective; not a technology silo perspective.
- ITIL reduces costs and helps with automation to further reduce cost. ITIL also lets you do more with less over time - avoiding future staffing cost increases.
- ITIL can be rolled out in 'gro
- ITIL makes people think from a Service perspective; not a technology silo perspective.
- ITIL reduces costs and helps with automation to further reduce cost. ITIL also lets you do more with less over time - avoiding future staffing cost increases.
- ITIL can be rolled out in 'gro
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
upings' of best practice to achieve organizational 'quick wins'
- ITIL should be fun. A way of doing things around here with people fully involved and included in key decisions.
It boils down to this...
Will the person sitting on a seat do the right thing at the right time at the lowest possib
- ITIL should be fun. A way of doing things around here with people fully involved and included in key decisions.
It boils down to this...
Will the person sitting on a seat do the right thing at the right time at the lowest possib
.
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 cost - in order to play their part in delivering the service that the customer pays for - keep on doing it right first time - and improve things where-ever possible?
Holy Grail?
No.
Already being achieved?
Absolutely! In lot's of different companies around the world. ITIL's been around for
Holy Grail?
No.
Already being achieved?
Absolutely! In lot's of different companies around the world. ITIL's been around for
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
years!!
Further Resources: -
To learn more about various ITIL aspects, visit: - www.ITServiceBlog.com
If you want to research ITIL, try: - http://www.ITServiceToday.com
For an understanding from the OGC, visit: - http://www.ITIL.co.u
Further Resources: -
To learn more about various ITIL aspects, visit: - www.ITServiceBlog.com
If you want to research ITIL, try: - http://www.ITServiceToday.com
For an understanding from the OGC, visit: - http://www.ITIL.co.u
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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