Enhanced regulatory requirements demand that GxP critical records comply with the ALCOA+ concept to maintain data integrity and quality. As a trusted advisor to the industry Eurotherm offers a range of solutions to help maintain data integrity throughout the data lifecycle.
What is ALCOA+ and why is it important in life sciences?
The Data Integrity ALCOA+ principles define best practice guidelines and methodologies for good data management, for example, within the pharmaceutical and biotechnology industries. The acronym ‘ALCOA’ defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate. In addition, ‘ALCOA+’ guidance recommends that data is also Complete, Consistent, Enduring, and Available.
Find out how Eurotherm products, systems, and services can help manage data integrity following these principles.
Discover more on the Data Integrity ALCOA+ concept, its role within the digital transformation of the Life Science Industry, and a view on data acquisition and management solutions that help achieve the required data integrity.Download White Paper
Who, when, what and why?
While sharing licenses can reduce system cost, it can violate the integrity of the metadata rendering it unattributable.
Password protected accounts determine permission for which actions can be carried out by a user’s role definition. Actions are logged within the audit trail, and the Security Manager feature can be linked to Microsoft® Active Directory for simplified and centralized user management.
Readable and permanent?
Paper records are susceptible to alterations and incorrect scaling of measured values. Tracking them can be complex.
Process data and alarm history are digitally available in readable form for realtime and historical views via the HMI, recorder screen, Data Reviewer software, SCADA interface, data historian and reporting packages. Metadata, including audit trail information is also available for analysis, queries and periodic reviews.
At the right time?
Lack of time stamping measures can encourage backdating and exclusion of data.
Process data and metadata (events, notes, messages, etc.) are automatically recorded at the time of the action against a timestamp. Recording devices can be synchronized across the system via connection to an SNTP (Simple Network Time Protocol) server.
Unaltered state and ‘true copy’?
Paper based records and data digitally recorded in CSV or TXT files can be easily edited and modified.
Original process data and metadata are digitally recorded and stored in Eurotherm proprietary tamper resistant binary-checksummed file format (.UHH).
Is it the right value/action?
Hand written records, poorly positioned sensors and measurement drift in recording equipment can lead to data misinterpretation and inaccuracies.
Recording digitally via high accuracy inputs, expertise in sensor positioning, and procedures to cover instrument loop calibration and validation, help to confirm that values read are representative of the actual process conditions.
Is all information available?
Values and actions recorded in different places, and communication dropouts during recording or archiving can lead to missing raw data/metadata.
Process data and operator actions are recorded in the same data file as part of an audit trail feature. Storing data initially in the recorder device, combined with a ‘Store and Forward’ feature, improves data capture reliability.
Is the sequence correct?
If not timestamped, the recording sequence and data audit trail cannot be relied upon.
Data is recorded chronologically, with the date and time stamp in the expected sequence. Process data, alarms and events stored in the UHH files can be viewed as a trend via Data Reviewer software, where inconsistencies or missing data are evident.
is it securely stored for long term use?
Paper trails can get lost or disintegrate over time.
Digitally recording data in a file format with long term compatibility retrieval support helps to ensure data is available from historian databases years after it is recorded.
Is the data accessible immediately?
Retrieving data from paper trails or multiple archives can be time consuming.
High availability system architecture, including uninterruptible power supplies (UPS) and redundant instrumentation, servers, historians and communication networks enable fast retrieval of data. Data Reviewer software can access data quickly by batch code, recorder/group name or time/date.