What is Data Integrity?
Data integrity refers to the completeness, consistency, and accuracy of data, and it is required to be ensured throughout the lifecycle of pharmaceuticals. To ensure data integrity, the principles of ALCOA+ are presented within various guidelines.
Principles of ALCOA+
- 1.Attributable: Data can be attributed to who did what, when, and where.
- 2.Legible: Data can be read by anyone.
- 3.Contemporaneous: Data is recorded and created at the time it occurs.
- 4.Original: Data is original or equivalent to the original.
- 5.Accurate: Data is recorded and created accurately.
- 6.Complete: All data exists, not just parts of it.
- 7.Consistent: Data is consistent and without contradictions.
- 8.Enduring: Data is protected long-term and exists throughout its lifecycle.
- 9.Available: Data is accessible and available for use at any time.
Ensuring data integrity is required for all data and records, regardless of whether they are on paper or in electronic form. It is an urgent issue in the pharmaceutical industry, as the reliability of data and records is directly linked to the reliability of the quality of the pharmaceuticals.
Data Governance
The establishment of data governance requires active involvement from senior management. Senior management is responsible for establishing the organization’s quality culture, maintaining and continuously improving it, and building an effective data governance system. They are also responsible for creating a corporate culture that provides an appropriate working environment, where everything can be reported openly and transparently. A quality culture centered around senior management should be established, along with a data governance system that ensures data integrity throughout the lifecycle.
Some specific policies and procedures for operating a data governance system include the following examples. (WHO Annex 4. Guideline on Data Integrity)
WHO Annex 4. Guideline on Data Integrity
- ■ management oversight and commitment;
- ■ the application of QRM;
- ■ compliance with data protection legislation and best practices;
- ■ qualification and validation policies and procedures;
- ■ change, incident and deviation management;
- ■ data classification, confidentiality and privacy;
- ■ security, cybersecurity, access and configuration control;
- ■ database build, data collection, data review, blinded data, randomization;
- ■ the tracking, trending, reporting of data integrity anomalies, and lapses or failures for further action;
- ■ the prevention of commercial, political, financial and other organizational pressures;
- ■ adequate resources and systems;
- ■ workload and facilities to facilitate the right environment that supports DI and effective controls;
- ■ monitoring;
- ■ record-keeping;
- ■ training;
- ■ awareness of the importance of data integrity, product quality and patient safety.
Examples of Observations in GMP Inspections Related to Data Integrity
In recent years, there is an increasing trend of observations related to data integrity in GMP inspections. Specific examples of such observations include:
Examples of Observations in GMP Inspections Related to Data Integrity
- 1.Data could be deleted or modified by all users.
- 2.There was no audit trail functionality for several pieces of testing equipment.
- 3.Retesting of samples was conducted without a legitimate reason, and some test data was deleted.
- 4.The head of the testing department had administrator access rights, creating a possibility of test result manipulation.
- 5.Data backup was not being conducted.
- 6.Blank formats were issued and managed by the manufacturing and testing departments, creating a possibility of record substitution, etc.
For data management, attention should be paid to the following points for both paper-based and electronic records.
Examples of points to note
for paper-based data management
- ・Identification of individual operators
- ・Management of the locations where records are used
- ・Use of permanent ink and methods for corrections
- ・Management of blank forms/templates
- ・Management methods for authentic copies
- ・Management of records printed out from electronic systems
- ・Versioning and issuance management
- ・Review and double-checking of records
- ・Filing, searching, storing, archiving, and discarding records
- ・Protection of records from disasters, etc.
Examples of points to note
for electronic data management
- ・Audit trail functionality
- ・System security
- ・Data management (raw data, metadata)
- ・Management of operational permissions (separation of system administrators and general users, etc.)
- ・Backup and archiving procedures
- ・Conducting CSV (Computer System Validation) at system implementation and periodic system verification
- ・System updates
- ・Data transfer methods
- ・Management of dynamic electronic data
- ・Methods for data review
CM Plus’s
Data Integrity Support Services
CM Plus offers the following support services for customers facing challenges with data integrity compliance.
Service 1Data Integrity Seminar
We provide clear explanations of key points and examples of observations related to data integrity compliance. We can also customize seminar plans according to the needs and concerns of our customers.
Service 2Data Integrity Consulting
We provide consulting on existing data governance systems to support our customers’ data integrity compliance. Specifically, we offer services such as:
- ・Gap analysis and improvement proposals for existing data governance systems and QMS
- ・Conducting mock inspections in preparation for GMP surveys
- ・Gap analysis and improvement proposals for existing computer systems
- ・Consultation and support for addressing inspection observations
- ・SOP review and creation support
Service 3Data Integrity Compliance and CSV Support During Computer System Implementation
When implementing computer systems, it is necessary to consider the implementation of features that meet data integrity requirements and to conduct CSV. We offer the following support for your system implementation projects:
- ・Support for creating CSV-related documentation for new systems
- ・Support for creating URS, including data integrity requirements
- ・Support for creating risk assessments related to data integrity
- ・Project management support for system implementation projects
Feel Free to Contact CM Plus
CM Plus has consultants from various fields who can customize services to meet your needs. Feel free to contact us.
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Useful Information
Please refer to our information dissemination site “GMP Platform” for related articles.
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