Data Integrity

Data Integrity:The extent to which all data are complete, consistent and accurate throughout the data lifecycle.

Data integrity is essential in a pharmaceutical quality system which ensures that medicines are of the required quality.

A robust data governance approach will ensure that data is complete, consistent and accurate, irrespective of the format in which data is generated, used or retained through put the data life cycle.

 “For electronic records to have the same integrity as paper records, they must be developed, maintained, and used under controls that make it difficult for them to be inappropriately modified.” - Steve Wilson, Deputy Director, FDA CDER

 Data Integrity Issue Are they Just Human Errors …..Willful Misconduct or Something More ….?.

Lack of quality culture throughout organization: Organizational culture is not just addressed by senior management putting the right words in a mission statement. What is necessary is that leadership shall clearly communicate expectations to staff at all the levels in the organization, and living by these principles…Walk the talk. Leadership, engagement and empowerment of staff at all levels in the organization can then combine to identify and deliver systematic data integrity improvements where good practice becomes automatic just as habits. Shall establish value based quality culture based on personal responsibility, ownership etc.

Data Life cycle: The Data Life-cycle is all phases in the life of the data (including raw data) from initial generation and recording, throughout processing (including transformation and migration), use, data retention, archive, retrieval and destruction. Failure to address just one link of the data life-cycle chain will deteriorate the effectiveness of the measures implemented elsewhere in the system.

Systems Design & Configuration: Consideration should be given to the organizational controls such as policies & procedures and technical controls such as system access applied to different areas of the quality system.

• Data review not limited to printed records - review of all electronic data.
• Controlled System admin privileges.
• Data integrity verification as a part of self-inspections

Data Integrity contributing factors:

• Leadership and KPIs can drive wrong behaviours.
• Inappropriate system design encourage bad practices.
• Culture of fear, blame and punishment.
• Poor attitude to problems- miss learning opportunities.
• Poor training, staff lack awareness.
• Don’t care, won’t get caught attitude.
• Lack culture of quality, doing it right when nobody is watching.

FDA’s Data Integrity Acronym-ALCOA

Data is “fit for use” (e.g., has integrity) if data is…

Attributable- attributable to the person generating the data.

Legible - It should not be possible to modify or recreate data without an audit trail which preserves the original record.

Contemporaneous- recording of data must be contemporaneous with the task being performed, and must identify both the person performing the observed task and the person completing the record.

Original- Original records and documentation, retained in the format in which they were originally generated (i.e. paper or electronic), or as a ‘true copy’.

Accurate –Data shall be accurately recorded by permanent means. Data review must include a review of raw data in its original form.

EMA Uses ALCOA+

Attributable, Legible, Contemporaneous, Original, Accurate, + Complete, + Consistent, + Enduring + Available.

Conclusion:

Data integrity issues can just as easily happen when good people are trying to do the right thing OR are trying to do what they think you as management want them to do.