Data Integrity
Data falsification, data fabrication, and other inappropriate data practices are occurring worldwide. The pharmaceutical industry is also facing similar issues, and the number of warning letters issued by the U.S. Food and Drug Administration (FDA) pointing out data integrity continues to increase. If a company cannot guarantee the completeness and accuracy of data that is the basis for the quality, safety, and efficacy of pharmaceutical products, its quality system will be deemed inadequate, which could lead to quality issues and significant damage.
Data integrity literally means completeness of data. The Pharmaceutical Inspection Convention/Pharmaceutical Inspection Joint Scheme (PIC/S) defines data integrity as the degree to which data is complete, consistent, accurate, and reliable, and these characteristic are maintained throughout the data lifecycle. The essence of data integrity is to prevent data fraud or acts that may be suspected of fraud (for example, keeping only good test data and deleting inappropriate test data) and to ensure the quality of medicines that affect life and health.
Data integrity is not a new requirement, but is considered to be a requirement within each existing requirement that reconfirms the risks to data completeness and accuracy and calls for the establishment of an appropriate data management system.
This concept is also incorporated into the revised GMP Ordinance, which was promulgated in April 2021 and came into effect on August 1 of the same year, which explains that it is necessary to ensure continuous reliability (so-called data integrity) from the time the records are created to the expiration of the retention period.
Data Integrity Regulations
Starting with the publication of guidance on data integrity by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in March 2015, related guidance has since been issued by the FDA, WHO, PIC/S, and ISPE (International Society for Pharmaceutical Engineering and Technology).
Table 1: Data integrity guidance from regulatory authorities and organizations around the world (as of July 2021)
| Issue date |
Issuer |
Regulatory Name |
| March 2015 |
MHRA |
MHRA GMP Data Integrity Definitions and Guidance for Industry (Official Version) |
| September 2015 |
WHO |
Guidance on good data and record management practices (draft) |
| April 2016 |
FDA |
Data Integrity and Compliance with CGMP Guidance for Industry (Draft) |
| May 2016 |
WHO |
Guidance on good data and record management practices (official version) |
| July 2016 |
MHRA |
MHRA GxP Data Integrity Definitions and Guidance for Industry (Draft) |
| August 2016 |
PIC/S |
GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS (Draft) |
| March 2017 |
ISPE |
GAMP Records and Data Integrity Guide (official version) |
| March 2018 |
MHRA |
MHRA GXP Data Integrity Guidance and Definitions (formal version) |
| December 2018 |
FDA |
Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry (official version) |
| July 2021 |
PIC/S |
Good Practices For Data Management And Integrity In Regulated GMP/GDP Environments (official version) |
Data Integrity Principles
ALCOA is an acronym for the basic principles of data integrity: Attributable, Legible, Contemporaneous, Original, and Accurate. The ALCOA principles are adopted in the data integrity guidance of MHRA, WHO, FDA, and PIC/S. "ALCOA Plus," which adds Complete, Consistent, Enduring, and Available to the above five items, is sometimes explained as the principles of data integrity.
Table 2: "ALCOA Plus" Principles
Attributable
(Attribution) |
The individual or device that observed, recorded, or corrected the data can be identified. |
Legible
(Legibility) |
All records must be readable. |
Contemporaneous
(Simultaneity) |
Record data at the time it is generated or observed. |
Original
(Originality) |
It must be either the original document as originally recorded or a true copy that preserves the content and meaning of the original. |
Accurate
(Accuracy) |
It must be error-free and trustworthy. |
Complete
(Completeness) |
When trying to understand an event, all the information needed to reconstruct the event is important.
For electronically generated data, a complete record includes associated metadata. |
Consistent
(Consistency) |
Documentation standards must be applied to all process, including process. |
Enduring
(Durability) |
To ensure that records are valid, ensure that they exist for the entire period that they are needed. |
Available
Availability |
During the period in which records are maintained, they can be retrieved and viewed at any time. |
Our Response
Data integrity is not limited to electronic records, but applies to all data including paper-based data and documents, and requires honesty as well as completeness, so calibration is required for measuring equipment. We offer Part 11-compliant wireless loggers, recorders, package software, and other products, and can quickly perform validation and calibration, providing total, flexible support for creating complete and accurate data.
Applicable products and services
Graphic recorder with measurement data protection function KR2P00
Paperless recorder with 6 and 12 input points
Although it is small, it has a wide range display and high performance, making it suitable for use as a standalone device or small-scale monitoring equipment.
When combined with the CISAS series, it can be configured as a recorder for a computer system.
Graphic recorder with measurement data protection function KR3P00
Paperless recorder with up to 48 input points
With its versatile display and high performance, it is suitable for data management on equipment such as stability testers, refrigerators, and freezers.
When combined with the CISAS series, it can be configured as a recorder for a computer system.
Electronic records management package software CISAS/ER
Measurement data recorded by Part 11-compliant wireless loggers and graphic recorder can be centrally managed as electronic records.
Graph display by viewing data, daily reports, monthly reports, and reports can be created (printed and output as PDF files) and electronic signatures are possible
JCSS (logo mark) calibration test
We are registration as a calibration laboratory for temperature and humidity under the Measurement Law.
We have also acquired certification as an "MRA-compliant certified business operator" based on ISO/IEC17025, and can issue calibration certificates with the JCSS certification symbol mark.
On-site inspection and calibration services
Our service technicians or contracted service personnel visit the user's site to inspect and calibrate measuring instruments, mainly temperature and humidity measuring instruments, regulators, recorders, etc.
