Now a days Various Company faced data integrity issues, Concern as below but not limited to:
Source: 483 Observation & WL.
1. Analytical record changed partial or full.
2. BPR/BMR page replaced partial or full.
3. Loos formats replaced and re-write, (entire page filled in same writing)
4. Training record of all employees filled in same writing by one person.
5. Documents not available at the time of audit partial or full.
6. Thermal printer used for data generation i.e. balance printer etc. hence ink is not durable.
7. Login password shared to each others, user or admin.
8. Delete option activate in GMP software.
9. Record/Report/GMP documents sign out of date/time.
10. Bunch Reports/Documents approved in very short time in evening hours when auditor left for the day of company premises and reviewed next day.
11. GMP documents identified in scrap yard area during audits.
12. GMP documents shredding in night shift during audit/before week of audit start, It was capture in CCTV camera of company premises.
13. Dummy documents shared to regulatory agencies and during audits of same agency, same documents not available.
14. Numerical value over-write or old value replaced with new value, but no
support documents for new value i.e yield, standard weight, calibration,
validation record, temperature monitoring record, etc.
15. Extended hours duty of all employees/Weekly off day, working all
employees, before audit start date.
16. Two persons but different statement in same department during
inspector visit on shop floor.
17. During audit hours/days, routine activity is very slow/not performed.
18. Documents not given to auditor for review, after multiple time reminder
by auditor.
19. Back dating/advance date documents sign.
20. During previous audit, promise to implement corrective action and share
the report/supporting data to regulatory agency, but when audit perform
for same point verification, then documents or system not in place.
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