“ALCOA Plus | ALCOA Importance in Validation & Data Integrity | Pharma”
I’m Rajat Shrivastava, your Guide in this short Article.
Today we will discuss about ALCOA+
I am sure you would have heard or read about ALCOA+ and few might be well aware of ALCOA+.
But there is always a room to learn something.
So, today we will discuss about what is ALCOA+?
If someone asks me or if I have to describe it in a single line then I will say it’s an A.B.C.D of Pharma Employee.
If you are serving Pharma then few selected words Like Audits 21 CFR Compliance, Data Integrity, ALCOA+ you will be hearing.
These all are linked with each other. We are preparing chain of articles and will cover all these topics.
But today we will discuss about ALCOA+
Now Data Integrity can be defined by ALCOA++ by following ALCOA+ Principal
I can understand whether my particular data is following Data integrity or not so what is ALCOA+?
Quickly moving ahead…
What is A for Attributable?
Any data, which generates Any COA, Chromatography Report, etc.
“That particular data” who generated and when? A generated detail is must So Who performed and When performed are attributes which is must.
This can be achieved by Audit Trail. From Software Audit Trail we can get data attributes.
What is L for Legible?
Any data which generates has to be in readable format.
If I will submit Chinese report then I doubt whether you will understand anything or not! It should be permanent means Data Life Cycle which is defined in SOP in that Duration Data should be available.
What is C for Contemporaneously?
Recorded As the name suggests contemporaneously means at the same time whenever data is generated, it should be recorded at same time Means Date and time stamps is must.
No Back Dated Data is allowed.
Very important point is No Back Dated work.
What is O for Original?
Any work I’m doing it’s source data or I say Primary Data should be available as it is Raw data; must be in original form whenever I want, I can access it.
Now 5th is
What is A for Accurate?
My Generated Data has to be Error free. If I’m doing any change in any data then it should be properly captured and documented as per my company’s SOP means Accuracy should maintain.
Now Comes + Parameters.
What is C for Complete?
My Data must be generated with all it’s information. It should contain METADATA.
Now what is METADATA?
METADATA is your data related with your data.
For an Example HPLC Data should have details like which method is used, Which Parameters were used, Method modifications, Audit Trail; all such information should be available so Data Should be Complete.
What is C for Consistent?
If a Data is repeated, it should not be changed, it should be consistent and it should be Traceable. Where i want to work in fixed workflow then there should not be any change in Data.
What is E for Enduring?
I have defined life cycle for my data. Take 5 years for an Example. So up-to 5 Years Data Should be maintain as it is with all information.
Hard Disk Crash, Data base Corrupt all such issues should not be there or otherwise it should be handled perfectly. So my data should last throughout its life cycle.
What is A For Available?
Available Data Should be available throughout its data life cycle.
Whenever i want to see data then it should be available or accessible; for any purpose like reviewing or audit.
So this is what ALCOA+ means to summarize it in one word or two words
I will say…
Attributable means who did and when did
Legible means it should be in readable form
Contemporaneous means Date and Time Stamp should there
Original means Raw Data or primary data should available
Accurate means Error Free Data
Complete means all information should be there with METADATA
Consistent means throughout similar Enduring means Data should not be corrupted
Last should be readily accessible.
I hope this article was very helpful to you. If you enjoy reading my articles, please do let me know in the comment section.
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