Definition: The accuracy, consistency, and reliability of temperature data throughout the cold chain. Encompasses data collection, transmission, storage, and protection from manipulation or loss.
Why It Matters: Data integrity is essential for regulatory compliance (GDP) and legal defensibility. Temperature records may be required as evidence in product liability cases. Regulators increasingly focus on data integrity in audits.
ALCOA+ Principles:
– Attributable: Who recorded the data
– Legible: Readable and permanent
– Contemporaneous: Recorded when it happened
– Original: First recording of data
– Accurate: Correct and truthful
– + Complete, Consistent, Enduring, Available
Key Elements:
– Calibrated monitoring devices
– Secure data transmission
– Audit trails for changes
– Backup and recovery
– Access controls
– Data retention policies
Related Terms: Temperature Monitoring, GDP, Validation, Audit Trail, Compliance