Introduction
Data integrity is essential to all validation processes in pharmaceutical and medical device manufacturing facilities. Understanding and following the ALCOA+ principles and how ClinSpark supports the ALOCOA+ principles are essential for understanding requirements for data integrity.
Data integrity is so interwoven with product quality, patient safety, and regulatory compliance, following the ALCOA+ principles is a high priority for the entire ClinSpark team.
Data Integrity is crucial in the pharmaceutical research industry and with advances in technology, the increased levels of automation, globalization of life sciences, and the use of contract manufacturers have made data integrity more important than ever.
ALCOA
Attributable
In order for data to be attributable, the following must be recorded:
identity of a person, system, sensor, equipment or device that collected, generated, or updated the data.
source of the data
the date and time
Legible
This principle is less of an issue with electronically captured data; however it is still relevant so that all data can be read and understood years after capture.
Manually (handwritten) data must be clearly legible.
this applies to uploaded handwritten data that may accompany the captured study data in ClinSpark such as Medical Records or Informed Consent procedures
All data collected must be able to be clearly understood years after the study has been conducted.
Consistent straightforward language is required.
Data collected, generated, or updated must be permanent.
Any and all data updates/ changes/ archival are accompanied by a timestamp as well as an Audit record providing a reason for change.
Contemporaneous
The essential recording of the actual time and date activities or actions take place
timestamping is essential to ensure data is not held in a queue, and recorded using system clocks that are accurate and record time zones. ClinSpark Timing Variables - Documentation - Confluence (atlassian.net)
main idea is that data is not updated at some point in the future. When data is updated after the initial collection, this can increase the chance of mistakes, incomplete data and inaccurate data collection/ recording.
Original
Data records should be original and not copies of data. Although this principle is less of an issue with electronically captured data; it is still relevant to ensure there are technical and procedural processes to ensure the original data collected (whether handwritten or digitally captured) cannot be changed.
initial recording of data should be the main record.
crucial to ensure there are technical and procedural processes to ensure the original data cannot be changed.
any analysis, reports, or calculations based on generated or collected data must be traceable to its original source.
Accurate
All data should reflect the reality of the activity or action and be error free.
no edits of initial data collection, and if there are edits or corrections necessary the original data should be documented in a way that the original data can be referred back to. (blocked out/ removed or deleted)
Electronic data collection systems must have built in accuracy checks and verification controls
equipment used for measurements should be calibrated regularly
ALCOA +
Complete
This principle pertains to the original recording, the metadata, retest data, analysis data, etc. and requires audit trail tracking for any changes made to the data
Consistent
Date and timestamp is expected to be in sequence, including the audit trail.
Enduring
Data must be durable enough to last long after it is recorded, decades in some situations.
a robust and well tested data backup system
data recovery system
disaster recovery plans
uninterruptable power supplies
cybersecurity
Available
Data must not only exist but must be accessible for audits, reviews and inspections.
data must be searchable
data must be properly indexed and labelled
readable at any time during the retention period
References
Any we want to cite?