Data with integrity is data that is created in such a manner that it is: attributable, legible, contemporaneous, original and accurate (ALCOA), and once established is maintained in a manner that ensures it is complete, consistent, enduring and available throughout its lifecycle.
This checklist has been published in response to the need to ensure compliance with the regulatory guidance for data integrity.
1. Data entries are performed on real time basis-no evidence of back dating.
2. Data entries are legible and clear.
3. Corrections are made so that original entry is not obscured and signed by the doer; corrections are dated and justified adequately.
4. Page numbering is in sequence- no evidence of replacement/missing pages.
5. The printout of the weighing balance is available for all the tests, involving weighing, conducted which directly or indirectly results into in-process material/batch release.
6. All log books (equipment, ware house, manufacturing, quality control, environmental monitoring, equipment usage & equipment maintenance etc.) are up to date, recorded on time basis and with entries corresponding to the actual actions.
7. Are all manual data entries verified, either by a second operator or by computerized means?
8. Extra copies of pages in the BMR/Analytical Test report are issued and authorized by the Quality Assurance department and the same is reflected on the document as such.
9. All the chromatograms are available along with the Analytical Report.
10. Are chromatograms sequential or are there numbers missing in the set?
11. Verify microbial media preparation and reconciliation and destruction record.
12. Verify Incubation record, Autoclave logs and ensure if it is as per validated loads and media preparation.
13. PLC has adequate control to prevent changes in process parameters e.g., the display shows the parameters as per specification but actual processing time has been changed in the PLC.
14. PLCs used in the manufacturing, testing or maintaining the critical process parameter are protected for password for individual users.
15. The computer system is password protected; all the personnel have dedicated windows log in and software log in user name & password?
16. Is audit trial is enabled for all instruments having associated computer system? If not, paper based audit trail are maintained?
17. Is the computer system is validated for its intended use?
18. Are the changes in line with standard company documentation and/or system change control procedural controls?
19. Is there a list for user and system roles for the overall system?
20. Is there a process to define the use of transferable media, USB memory drives or external hard drives?
21. Do SOPs exist on how data is backed up that incudes how often and what happens if a failed back up occurs?
22. Has periodic review of backed-up data been completed in compliance with site procedures?
23. Is there an IT Disaster Recovery Plan and does it address data governance?
24. Does the system require documentation of a reason for change or deletion of GxP data?
25. Check Recycle bins for any files & folders related to analytical data.
We hope this checklist will be helpful to comply the regulatory requirements on data integrity in pharma industries. This is a template for assessing a system for data integrity regulatory compliance.
