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Viewpoint
Elanco is a world leader in developing innovative products and solutions that enhance animal health, empowering the people that raise and care for animals.
Solving Problems – Ideation is often specifically aimed at problem-solving. ... Innovation – An example of innovation ideation is the process of a pharmaceutical company developing new medicines. Such a type of ideation often involves doing extensive research and experimentation as part of the ideation process
#ALCOA
ALCOA
Attribute
ALCOA is an acronym for the original five principles of data integrity
Attributable Legible Contemporaneous Original Accurate
ALCOA is an acronym for the original five principles of data integrity. Those principles are:
Attributable
Legible
Contemporaneous
Original
Accurate
However, the original ALCOA principles have since been updated to ALCOA+. The original principles remain with four additions:
Complete
Consistent
Enduring
Available
Data integrity is essential to all validation processes in pharmaceutical and medical device manufacturing facilities. Following the ALCOA+ principles is the best way to achieve this goal.
Anna Owaka
#ALCOA+
ALCOA+ is a framework or set of principles that ensures data integrity. It was introduced by, and is still used by, the FDA – the US Food and Drug Administration
It has relevance in a range of areas particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain
As well as being essential for compliance reasons, the ALCOA+ principles are becoming increasingly important to GMP (Good Manufacturing Practices)
ALCOA is an acronym for the original five principles of data integrity.
Those principles are:
Attributable Legible Contemporaneous Original Accurate
However, the original ALCOA principles have since been updated to:
The original principles remain with four additions:
Complete Consistent Enduring Available
#ALCOA
Data Integrity and Validation
Data integrity is essential to all validation processes in pharmaceutical and medical device manufacturing facilities.
Following the ALCOA+ principles is the best way to achieve this goal.
Viewpoint
Elanco is a world leader in developing innovative products and solutions that enhance animal health, empowering the people that raise and care for animals.
Solving Problems – Ideation is often specifically aimed at problem-solving. ... Innovation – An example of innovation ideation is the process of a pharmaceutical company developing new medicines. Such a type of ideation often involves doing extensive research and experimentation as part of the ideation process
#ALCOA
ALCOA
Attribute
ALCOA is an acronym for the original five principles of data integrity
Attributable Legible Contemporaneous Original Accurate
ALCOA is an acronym for the original five principles of data integrity. Those principles are:
Attributable
Legible
Contemporaneous
Original
Accurate
However, the original ALCOA principles have since been updated to ALCOA+. The original principles remain with four additions:
Complete
Consistent
Enduring
Available
Data integrity is essential to all validation processes in pharmaceutical and medical device manufacturing facilities. Following the ALCOA+ principles is the best way to achieve this goal.
Anna Owaka
#ALCOA+
ALCOA+ is a framework or set of principles that ensures data integrity. It was introduced by, and is still used by, the FDA – the US Food and Drug Administration
It has relevance in a range of areas particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain
As well as being essential for compliance reasons, the ALCOA+ principles are becoming increasingly important to GMP (Good Manufacturing Practices)
ALCOA is an acronym for the original five principles of data integrity.
#ALCOA
Data Integrity and Validation
Data integrity is essential to all validation processes in pharmaceutical and medical device manufacturing facilities.
Following the ALCOA+ principles is the best way to achieve this goal.
Those principles are:
Attributable Legible Contemporaneous Original Accurate
However, the original ALCOA principles have since been updated to:
The original principles remain with four additions:
Complete Consistent Enduring Available
Complete
Consistent
Enduring
Availabe
Attributable
Legible
Contemporaneous
Original
Accurate
The drivers for this include enhanced regulatory requirements
in addition to the evolving expectations of consumers and end users
as well as the increasingly competitive nature of the pharmaceutical industry.
Paper based
Electronically recorded
Hybrid - Combination of paper and electronic
Other Photos Images etc
Types of data
Legible-All about being able to read the data
Attributable - you must record the source person computer etc &the date
#Contemporaneous-record the activity when it happens
Original - Record should be original rather than copies Or transcriptions
#Accurate - Record the accuracy of the activity error free
Definition of terms
You can’t just have data, though.
Instead, you need to have data and you need to ensure the integrity of that data.
When you have this, you have data you can use and rely on.
3 reasons why we focus on Data Integrity
Consumerism - the protection or promotion of the interests of consumers.
Increasing Regulations we are subject to tighter regulations
Ask yourself Why?
Elanco is a world leader in developing innovative products and solutions that enhance animal health, empowering the people that raise and care for animals.
Pharmaceutical & Medical Device Manufacturing
Competition in our Industry
why add 4 more with +
and what do they Mean
ALCOA+ Part III
Available Enduring Complete & Consistent
Elanco is a world leader in developing innovative products and solutions that enhance animal health, empowering the people that raise and care for animals.
We are Elanco
#Complete - All recorded data requires an audit trail to show nothing has been deleted or lost
#Consistent - This primarily means ensuring data is chronological, i.e. has a date and time stamp that is in the expected sequence
#Enduring - While this is touched on in a previous principle, this principle of ALCOA+ #places specific emphasis on ensuring data is available long after it is recorded – decades in some situations
#Available - This point follows on from the last point, i.e. #data must not only exist, it must be accessible. The most efficient way of achieving this is normally by recording data electronically.
Data Integrity & Validation - Data integrity is essential to all validation processes in pharmaceutical and medical device manufacturing facilities #Following the ALCOA+ principles is the best way to achieve this goal
then Summarize Video and GIF
Journal with TS & @Noteshelf an unbeatable Team
#ALCOA+
ALCOA is an acronym for the original five principles of data integrity. Those principles are:
Explaining ALCOA+
Nikki #03Dec
Feedback
Colin updating
GLP training
My presentation
Refresher traing Focus on gaps new reqts
OECD new documents
Integrate
Material is shared
Small project
#OECD #Website
Advisory Document #22