How secure is the data your business holds?
What does 'secure' even mean in practice?
ALCOA+ is a set of 9 data integrity principles introduced by the FDA and central to GxP operation.
Using ALCOA+ as a checklist for your document management system is a great way to ensure you've embedded full data integrity - and managing your documentation electronically is critical for meeting its requirements.
Qualsys Training Manager Kaye Eames delivered a presentation at the summer 2019 Qualsys user group about working to ALCOA+ with EQMS Document Manager.
We break down each ALCOA+ principle and how to meet them below.
Principle #1: Attributable
The first principle of ALCOA+ can be summarised quite simply:
The person who performs a data-related task must be identifiable as the person who performed that task.
Document Manager's dedicated log-in functionality 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 Manager 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.
Document Manager is built around a customisable 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.
Document Manager 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 Manager 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System admins can access any version of a document or record, with superseded versions backed up and stored for full traceability.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.
Document Manager contains multiple safeguard features 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 ALCOA+.
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 Document Manager 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, and changes made to a document in one area should be reflected in all other areas.
Document Manager 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 Document Manager 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.
Document Manager is designed to give users a single, centralised, reliable source of aligned business information.
Bespoke viewing permissions mean documents are available for the right personnel at the right time - creating more standardised and transparent processes.
Next steps
Want to learn more about Document Manager?
Schedule a quick chat with us at a time that suits you:
Share your thoughts on this article