Signals Notebook: ALCOA+ Compliance

Signals One, a product from Revvity Signals, is designed to support compliance with ALCOA+ principles, ensuring data integrity and reliability. ALCOA+ is a set of guidelines widely adopted in regulated industries, particularly in pharmaceuticals and life sciences, to ensure data quality and trustworthiness. These principles include Attributable, Legible, Contemporaneous, Original, Accurate, along with additional considerations such as Complete, Consistent, Enduring, and Available.

This article outlines how Signals One adheres to the core ALCOA+ principles.

ALCOA+ Principles in Signals One
 

1. Attributable
Definition: Data and actions must be traceable to a specific individual or source.
How Signals One Ensures This:
Every action and change within the system is traceable to a specific user.
Signals One maintains a robust Audit Log that records user activities, including data creation, modifications, and deletions.
User authentication and role-based access control ensure accountability.
 

2. Legible
Definition: Data must be clear, readable, and understandable.
How Signals One Ensures This:
Data and logs are presented in a structured, user-friendly format.
The system interface is designed to ensure clarity, reducing the risk of misinterpretation.
Logs and reports are easily accessible and formatted for regulatory review.
 

3. Contemporaneous
Definition: Data must be recorded at the time of the event or action.
How Signals One Ensures This:
Signals One records changes in real-time, ensuring timestamps accurately reflect when events occurred.
The system automatically captures the date and time of data entries and modifications.
 

4. Original
Definition: Original data must be preserved, and any changes must be documented.
How Signals One Ensures This:
Original data is securely stored and remains unaltered.
The system tracks all changes through version histories, allowing users to view previous versions of data.
Signals One prevents unauthorized overwriting of original data.
 

5. Accurate
Definition: Data must be correct, reliable, and free from errors.
How Signals One Ensures This:
Controlled user privileges and workflows minimize the risk of errors.
Validation checks and system controls ensure data accuracy during entry and processing.
Signals One supports data review and approval workflows to maintain accuracy.
 

Practical Applications of ALCOA+ Compliance in Signals One

Regulatory Compliance: Signals One helps organizations meet regulatory requirements, such as FDA 21 CFR Part 11 and EU Annex 11, by adhering to ALCOA+ principles.
Audit Readiness: The robust Audit Log and version history features ensure that organizations are always prepared for audits.
Data Integrity: By preserving original data and maintaining accuracy, Signals One ensures the integrity of critical information.