Data Integrity: the cornerstone of compliance & patient safety
In today’s highly regulated life sciences industry, data integrity is non-negotiable. It is the foundation of Good Manufacturing Practices (GMP) and ensures that all recorded data is complete, consistent, accurate and reliable throughout its lifecycle. Without it, pharmaceutical and biotech companies risk regulatory non-compliance, compromised patient safety and damaged reputations.
Data integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data lifecycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate.
THE ALCOA+ FRAMEWORK FOR DATA INTEGRITY
The ALCOA+ framework is the gold standard for ensuring that data remains trustworthy and compliant in regulated environments.
Attributable
Clearly linked to the person who generated it
It should be clear who created a record and when. Likewise, it should be clear as to who amended a record, when and why. That last one, the why (the reason for change) is an important area in which there are frequently gaps. There is some room for self evident reasons for change, but many take an overly broad definition of self evident. It is always best to explain why an entry is being changed.
Legible
Readable, traceable and permanently preserved
Data are readable, understandable, and allow a clear picture of the sequencing of steps or events in the record so that all activities conducted can be fully reconstructed by the people reviewing these records at any point during the records retention period.
Contemporaneous
Recorded in real-time, without delays
To record the result, measurement or data at the time the work is performed. Date and time stamps should flow in order of execution for the data to be credible. Data should never be back dated.
Original
The first and true record (or a verified copy)
Original data, sometimes referred to as source data or primary data, is the medium in which the data point is recorded for the first time. This could be a database, an approved protocol or form, or a dedicated notebook. It is important to understand where your original data will be generated so that its content and meaning are preserved.
Accurate
Free from errors, truthful and complete
For data and records to be accurate, they should be free from errors, complete, truthful and reflective of the observation. Editing should not be performed without documenting and annotating the amendments.
How to Ensure Data Integrity Compliance
To maintain regulatory compliance and protect patient safety, companies must implement robust quality and risk management systems. Regulatory bodies such as the FDA, EMA, WHO and PIC/S have clear expectations for data integrity compliance. Failure to meet these standards can lead to severe consequences, including regulatory action and loss of market authorization.
Comprehensive documentation practices
If it’s not written down, it didn’t happen.
Automated data capture & audit trails
Minimize human errors and improve traceability
System validation & security controls
Prevent unauthorized access and data tampering
Regular Data Integrity risk asssessments
Identify vulnerabilities before they become violations
Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.
Strengthening Your Data Integrity Strategy
Agidens specializes in helping life sciences companies establish robust data integrity frameworks that align with the latest industry regulations. Our expertise spans:
- Data integrity audits & gap assessments
- GMP-compliant documentation & training
- System validation & compliance strategies
- 21 CFR Part 11 & Annex 11 compliance
Don’t leave data integrity to chance
By proactively managing data integrity, your company can enhance compliance, reduce risks and safeguard patient safety. Don’t leave data integrity to chance. Ensure your organization is fully compliant and audit-ready.
