How to meet all 9 ALCOA principles with our document module

The ALCOA principles (or ALCOA+) are a set of 9 data integrity principles introduced by the FDA and are central to GxP operation. Using ALCOA documentation principles as a checklist for your document management system is a great way to ensure you've embedded full data integrity. Managing your documentation electronically is also critical for meeting its requirements.

We break down the ALCOA+ principles and how to meet them below.

Principle #1: Attributable

The first principle of ALCOA+ can be summarized quite simply:

The person who performs a data-related task must be identifiable as the person who performed that task.

Ideagen Quality Management’s document module has a dedicated log-in functionality which fulfils this requirement by providing each user with a unique name and password.

Coupled with good ISO 27001 practice like screen locking and credential security, this allows any document module action, from document uploads to updates and feedback, to be reliably traced to a single user.

Principle #2: Legible

The 'L' of ALCOA+ refers to legibility. In other words:

Data should be readable and understandable, with a clear picture of the step/event sequence that data has passed through.

The document module is built around a customizable and repeatable action tree, with full audit trail visibility of each document's journey.

Principle #3: Contemporaneous

Data activity should be timestamped with a record of when it took place.

This ensures the document module fulfils the requirement of contemporaneous activity records by automatically populating and saving the date and time of every document modification.

Principle #4: Original

Access to original data means:

Every originally captured piece of data must be retained, rather than replaced or deleted.

Document module operates with data archiving functionality. System admins can access any version of a document or record, with superseded versions backed up and stored for full traceability.

Principle #5: Accurate

The second 'A' of ALCOA+ stands for accuracy. In other words:

Data should be inputted, stored and maintained with precision and validity.

There are multiple safeguard features within the document module to prevent uncontrolled changes, while automated review reminders and prompts encourage documents to be checked and maintained at regular intervals.

Principle #6: Complete

Beyond the 5 original ALCOA data integrity principles, 4 more were added to create the ALCOA+ principles.

The sixth ALCOA+ principle is that of complete data, where:

Data features a trackable audit trail to prove that nothing has been deleted or lost.

Each document within the document module features a dedicated history demonstrating every update and amendment since its addition.  

Principle #7: Consistent

Data should display consistently, wherever it is accessed from within your document management system.

Record consistency requires change and version management with traceability matrices. Changes made to a document in one area should be reflected in all other areas. Our document module is designed to present documentation consistently, archiving outdated versions automatically to create a single source of up-to-date documentation which all users access identically.

Principle #8: Enduring

An ALCOA+-compliant document management system requires data that endures. Which means:

Records and information should be accessible and readable during the entire period in which they might be needed... potentially decades after recording!

System back-ups within the document module prevent data being lost in the event of disruption, while archived documents are stored indefinitely within the system for reference at any point in the future.

Principle #9: Available

Perhaps the most significant component of your document management system is availability:

Documents and records should be accessible in a readable format to all applicable personnel responsible for their review or operational processes.

External users should also be provided access for inspection/review where necessary.

Our Document module is designed to give users a single, centralized, reliable source of aligned business information. Bespoke viewing permissions mean documents are available for the right personnel at the right time - creating more standardized and transparent processes.

Next steps

Put your understanding of the ALCOA principles into practice by seeing how Ideagen Quality Management’s document module assisted BT with their document management, revolutionizing their older system to give them a standardized approach across the business.