In my last blog, I talked about data harmonization…
And the importance of being able to standardize data formats in order to ensure reliable analysis and decision making from it.
But I left out another part of what standardizing data enables that’s going to become more and more important going forward…
In 2024, this is something every data heavy operation is rushing to implement into their workflows.
It’s Artificial Intelligence.
Providing AI with standardized data allows it to improve data quality and consistency, enable seamless integrations, ensure interoperability, support scalability, and facilitate better predictive analytics, decision-making, and regulatory compliance.
But the problem is…
There is a large gap in the pharma industry that must be filled before AI can be unleashed…
Unlike other industries, there are fewer industry wide standards and the manufacturing processes reflect the combined complexities of intellectual property and regulation.
Regulation is nowhere close to a one size fits all solution, (as you might see in computer chip manufacturing).
This is largely because of how unique the manufacturing process is for every critical drug and vaccine.
Though the FDA requires that operations document their “good manufacturing processes” and they can provide guidance on how to stay in line with the current standards and regulations…
Like 21 CFR Part 11…
They don’t have any regulation regarding a standard data format.
So Why is This Important?
Because of the intellectual property, good manufacturing procedures and the established IT Architecture…
2.5 Petabytes of Mission Critical Data is “Siloed” Every Single Day…
And left completely out of AI’s reach.
This might sound crazy but these numbers are based on our conversations with Merck and other industry leaders…
But everyday one critical instrument produces 500MB of data.
Worldwide there are 5,000,000 critical instruments currently in operation on the floors of drug manufacturing facilities.
That means that every day 2.5 petabytes of data is produced and basically lost without a data standardization system in place.
That’s also 250,000,000 MB/day!
Which also turns into 1.25 pages of standard type paper a day in the biopharma industry.
What a waste!!!
So What Can Change?
While it would be a game changer if manufacturers of these critical instruments came together and created a singular format for each device…
That is never going to happen.
What’s more realistic?
A system that can be implemented into a drug manufacturing operation and transform the data based on the specific instruments that they have.
That’s where Phizzle comes in…
Phizzle’s Data Transformation Engine has the ability to standardize any operation’s data.
Regardless of how many different data formats there are on their critical instruments…
Regardless of manufacturer, make, or model.
Phizzle provides a solution that allows any operation to fully harness and utilize ai to get the most out of their data.
Meaning more data quality and consistency, more seamless integrations, more reassurance interoperability, more support scalability, and better predictive analytics, decision-making, and regulatory compliance.
If you want to see for yourself and take our software for a spin, click here to get access to our sandbox.
Where you can remotely sample air particle counters, review data in accordance with 21 CFR Part 11, and view detailed sample data and audit logs that our solution generates.
All from your lap top.
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