Just like pharmaceutical products must meet quality attributes, the data from a computer system must also meet those attributes.
You may have heard of ALCOA; Attributable, Legible, Contemporaneous, Original, and Accurate.
But ALCOA+ is the latest standard for Data Integrity. It stands for ALCOA but includes Complete, Consistent, Enduring and Available.
A– Attributable to the person generating the data
L- Legible, Traceable and Permanent
O- Original record or certified true copy
A – Accurate
This is a list of a questions to ask yourself and consider in your organization:
Does your systems use unique user logins?
Does your systems have Audit Trails?
Are the systems being backed up?
Does your system have electronic signatures?
Perform a Data Integrity assessment to determine any gaps in compliance with Data integrity requirements.
Build a comprehensive remediation plan
Implement and manage the deliverables identified above.
Why CSI? CSI is a specialty consulting firm with over 20 years of experience providing our services to the Pharmaceutical and Biotech industries. We understand compliance, validation and data integrity and how to relate Information Technology to the business’ goals and drivers. Our aim is to make IT a beneficial contributor to the business, not just a cost center.
For more information visit the FDA site
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