Data integrity refers to the completeness, consistency, and accuracy of data. Where complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA) throughout the lifecycle of the product.
Data integrity is a requirement of current good manufacturing practice (cGMP) for drug substances and drug products as per 21 CFR parts 210, 211, and 212. It is the basement of pharmaceutical industry to ensure that drug products are safe to the patients.
Principles of Data Integrity
Personnel should follow good documentation practice (GDocP) for both paper records and electronic records in order to assure data integrity. These principles require that documentation has to follow ALCOA or ALOCA+.
ALCOA Principles
The acronym ‘ALCOA’ means the data should be attributable, legible, contemporaneous, original, and accurate. These essential characteristics apply equally for both paper and electronic records.
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Attributable
It means the information is captured in the record so that it is uniquely identified as executed by the originator of the data.
Legible
It refer to the requirements that data are readable, understandable, and allow a clear picture of the sequencing of steps or events in the record.
Contemporaneous
It ensure the data are recorded at the time they are generated or observed.
Original
It include the first or source of data and all subsequent data required to fully reconstruct the conduct of the GXP activity.
Accurate
It means data are correct, truthful, complete, valid and reliable.
Related: Data Integrity in Analytical Laboratories
ALCOA+ Principles
In addition with ALCOA, ‘ALCOA+’ refers to the data should be complete, consistent, enduring and available.
Complete
All information that would be critical to recreating an event is important when trying to understand the event. A complete record of data generated electronically includes relevant metadata.
Consistent
Information should be created, processed, and stored in a logical manner that has a defined consistency.
Enduring
Records should be kept in a manner such that they exist for the entire period during which they might be needed.
Available
Records should be available for review at any time during the required retention period, accessible in a readable format to all applicable personnel who are responsible for their review whether for routine release decisions, investigations, trending, annual reports, audits or inspections.
Data Integrity Examples in Pharmaceutical Industry
- No manipulation in data entry
- Maintain the sequence during data entry or recording
- No backdating
- No false record or foul play
- Names and passwords keep private
Read also: Frequently Asked Questions on Data Integrity