Test your Data Integrity with These 12 Questions

The FDA describes data integrity as the completeness, consistency, and accuracy of data through its lifecycle. Data integrity also encompasses the way we capture said data, how it’s transferred and stored, how we back up, archive it or destroy it, and how it’s protected. 

Continuous monitoring of environments comes with tremendous amounts of data to process, so the methods for procuring, assessing, and adequate data protection are incredibly important: 

• Accurate and reliable data capturing ensures that the information collected is precise, consistent, and ready for further processing. 
• Effective data transfer maintains data integrity as data moves across systems and interfaces. Data transmission should be secure and accurate to prevent data tampering and loss. 
• Adequate data protection safeguards data from unauthorized access and ensures its integrity over time; this is vital for compliance and operational reliability. 

This data we process should follow the ALCOA principles. According to these, data should always be: 

• Attributable: Data should always be linked to the individual that created it or modified it, to ensure accountability and traceability. 
• Legible: Data should be readable and understandable, to ensure accuracy when interpreted and reviewed. 
• Contemporaneously recorded: The data should be recorded the moment it has been generated, or immediately after, to ensure relevance. 
• Original or a true copy: Data should be kept in its original form, or if not possible, as a verified copy, to ensure authenticity and reliability.  
• Accurate: Data should accurately reflect the observed facts, free from alterations or errors, to ensure credibility.  

There are many challenges to overcome when ensuring data compliance. From human error to system failure, these issues can delay your audit readiness and increase the risk of asset loss.  

We have created a list with 12 questions based on industry regulations. By answering them, you can evaluate your compliance with data integrity standards: 

1. Is there an approved SOP for data review? 
2. Are data transfer interfaces secure and tamper-proof? 
3. Are data encryption and checksums in place to ensure data integrity during transfer? 
4. Is there a comprehensive migration strategy for legacy data? 
5. Are old data formats compatible or convertible to new systems? 
6. Is there a protocol for maintaining system updates? 
7. Does the system require unique identification for each user? 
8. Does the system time out after a period of inactivity?  
9. Are all data changes logged in a secure audit trail? 
10. Is data backup performed regularly? 
11. Are there protocols for user access levels and task segregation? 
12. Is there a regular review process for SOP compliance and system readiness? 

Your success is our priority. We’ve put together a comprehensive data integrity checklist that aligns with the structured guidance provided by the PIC/S following industry regulations to help you maintain your data integrity in the easiest way possible.