DATA INTEGRITY FROM THE INSPECTOR’S POINT OF VIEW

Ivan Bašic, Ph.D.Croatian Agency for Medicinal Products and Medical Devices

Data Integrity?- Data integrity requirements apply not only to electronic data and electronic systems.- All phases in the life of the data, from initial generation to destruction.

Initial generation

Destruction

Recording ProcessingRetention

Archive & Retrieval

ReportingReviewing

What are data?

Data = Information derived

or obtained from raw data*

Raw data = Original records

and documentation, retained

in the format in which they

were originally generated

(i.e., paper or electronic

format), or as a ‘true copy’*

What are examples of GMP data?

• Analytical test results

• Batch record entries

• Logbook entries

• Information in a customer complaint

Why the focus on data integrity right now?

Data integrity is not new.

Regulatory agencies have

had data integrity

requirements for a long time.

Why is data integrity becoming an increasing issue?

• Evolving documentation practices (computers)

• Evolving business models

• Increasing globalization

What is data integrity?

Data integrity is the extent to which all data are complete, consistent, and accurate throughout the data lifecycle

Implications:

• Data should be recorded exactly as intended

• Upon later retrieval, data should be the same as when it was originally recorded

Data integrity

- MHRA data integrity guide- FDA Guidance - Health Canada policy - WHO guidance - PIC/S Guidance (draft) - etc.

ALCOAAttributable

Legible

ContemporaneousOriginal

Accurate

ALCOA+ Attributable

Legible

Contemporaneous

Original

AccurateComplete

Consistent

Enduring

Available