💡 If it isn't documented correctly, it didn't happen.
The industry standard for data integrity is defined by the ALCOA+ acronym: Who performed the action and when? Legible: Can the data be read and understood forever? Contemporaneous: Documented at the time of the activity. Original: The first recording or a certified true copy. Accurate: Reflects the reality of the observation.
Build a "No-Blame" environment to encourage error reporting. Data Integrity in Pharmaceutical and Medical De...
Regularly test computerized systems for intended use.
If you tell me your , I can tailor this further: Training module for new laboratory staff White paper for executive leadership Audit checklist for quality assurance teams 💡 If it isn't documented correctly, it didn't happen
Includes all data, including repeats or reanalysis.
Data integrity ensures that pharmaceutical and medical device products meet safety and quality standards. Without it, regulatory trust dissolves, and patient safety is compromised. Core Principles (ALCOA+) Contemporaneous: Documented at the time of the activity
Follows a chronological, audit-trailed sequence.