What is Data Integrity?
Due to the increasing number of findings related to data falsification and misconduct in inspections, regulatory authorities such as the FDA(U.S. Food and Drug Administration) and MHRA (UK Medicines and Healthcare products Regulatory Agency) are strengthening their oversight of data integrity. As a result, various regulatory authorities have been issuing a series of guidelines on data integrity. The basic principles of data integrity, known as ALCOA+ (A: Attributable, L: Legible, C: Contemporaneous, O: Original, A: Accurate, C: Complete, C: Consistent, E: Enduring, A: Available), have been adopted in these guidelines. The SMARTDAC+ GX/GP/GM with advanced security functionality is compliant with data integrity requirements.
SMARTDAC+ Paperless Recorder and Data Logger Supports Data Integrity
Electronic Signature
Measurement data can be displayed and confirmed on the recorder itself or the Standard Universal Viewer software, and an electronic signature can be applied to that data. Three levels of signature are available: operator, supervisor and quality control. The signature along with information such as pass/fail and comments can be saved to the data for review and audit.
Audit Trail Function
The operation log is saved to a file along with measurement data. When settings are changed, it is possible to record the reason for the change along with the setting change operation.
This feature allows you to confirm who, when, what, and why changes were made as required for data integrity. The operation log can be viewed on the recorder screen, in the web application, or in the Universal Viewer.
Logical Security
There are four user levels (two separate administrator roles, user and monitor user), and up to 200 users can be registered. Access privileges can be assigned separately to each second administrator and user.
Data integrity requires that the appropriate users have access to the appropriate information. SMARTDAC+ allows you to create users with various access privileges.
Guideline and Data Integrity Support
Guidance issued by each regulation authority are listed below.
Guidance
| Publication Date | Institution | Guidance Name |
|---|---|---|
| October 2021 | WHO | Guidance on data integrity |
| March 2018 | MHRA | ‘GXP’ Data Integrity Guidance and Definitions |
| July 2021 | PIC/S | GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATION GMP/GDP ENVIRONMENTS |
| December 2018 | FDA | Data Integrity and Compliance With Drug CGMP Question and Answers Guidance for Industry |
*As of May 2025
SMARTDAC+ compliance with ALCOA+ principles is outlined below.
ALCOA+ Principle of Data Integrity
| ALCOA+ | Content | SMARTDAC+ correspondence |
|---|---|---|
| Attributable | It must be clear who created the data | Capable of recording the user, timestamp, and operation history with an audit trail function. |
| Legible | Data must be legible to anyone | Data can be displayed and saved in a format that is readable by humans. |
| Contemporaneous | Data must be recorded at the time of measurement | Measurement data is automatically and promptly recorded together with a timestamp. |
| Original | Copied data must be identical to the original data | A recorded data file is saved in a unique format that cannot be tampered with. Therefore, any copied data is identical to the original. |
| Accurate | Data and results must be accurate without any errors | Data acquired from calibrated sensors is accurately saved in a unique format that cannot be tampered with. |
| Complete | All necessary information must be available to reconstruct the situation | All information regarding data acquisition and operation such as measurement values, setting information, operation history, alarm history, and so on is saved in the data file. |
| Consistent | Data must be consistent and contain no contradiction | SMARTDAC+ equipped with an SNTP function, records data continuously at the set interval. Channel info, units, and timestamps are automatically added to measurement data, and all user actions are securely tracked in an audit trail. |
| Enduring | Data must be available during the retention period | Data can be backed up on long-retention media. By saving the viewer software together with the data, it is possible to ensure future accessibility in a readable format. |
| Available | Data must be accessible at any time during the retention period | Recorded data can be searched and viewed by dedicated viewer software. This ensures reliable access to the data when needed. |
Related Products & Solutions
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Modular GM10
SMARTDAC+TM GM10 data logger has a modular architecture that can acquire necessary data. By supporting not only I/O but also many communication protocols such as 920MHz wireless, Modbus and so on. Monitor and setting changes are available through Bluetooth. Supporting FDA 21 CFR Part11 and AMS2750E/NADCAP.
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Touch Screen GP10/GP20
The SMARTDAC+TM GP10/GP20 is a portable paperless recorder with a modular architecture on the back panel and has a data logging function to acquire the required data. By supporting not only I/O but also many communication protocols, you can connect to various devices. GP utilizes AI. Supporting FDA 21 CFR Part11 and AMS2750E/NADCAP.
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Touch Screen Paperless Recorder GX10/GX20
The SMARTDAC+TM GX10/GX20 is a panel mount paperless recorder with a modular architecture on the back panel and has a data logging function to acquire the required data. By supporting not only I/O but also many communication protocols, you can connect to various devices. GX utilizes AI. Supporting FDA 21 CFR Part11 and AMS2750E/NADCAP.