Documentation checklist for Customer Complaints and Potential Recall

Sl No Customer Complaints, AE/SAE and Safety Information Ref Report

Doc No -014048; 027542; 008782; 112556; 110067
1. Yes
Do you have an agreement with IPS covering safety reporting
related to spontaneous and clinical trials
2. The IPS signed responsible JD mentions the safety responsibility IPS agreement signed by SSUR
3. Do you have a responsible to screen the medical journals for Yes
AE/SAE/SI and his/her JD mentions the responsibility
4. Do you have the documentation on medical journal screening yes
Month wise
5. Do you have a procedure for distributor to handle customer yes
complaints
6. Are all the employees trained in Customer Complaint handling – Yes
check with the current organogram
7. Do you have any pocket guide for sales employees on handling Yes
of complaints. Is yes it version controlled
8. Is the JD of the employee handling CC/AE/SAE mentions the Yes
responsibility
Does the JD of back up for handling CC/AE/SAE mentions the
responsibility
9. Do you have the list of customer complaints for the year 2007, yes
2008 and 2009 for tracking and closing of complaints
10. Are the monthly logs reviewed, signed and dated Yes
11. Check the final log for the year has all the customer complaints Yes
reported in the year
12. yes
Did you transcribed the information on to the CC log correctly

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 13. Check if all the complaints are classified correctly yes
14. Check if the information sent to CCC/IPS is same as the source yes
information
15. Check if you have made any changes in the customer complaint NA
form/ source information and they are signed and dated
16. Check if the information collected over phone is documented and yes
signed and dated
17. Do you send the complaint samples to CCC or the distributor
sends.
18. Is all the information related to the case is filed with the case - yes
Initial information, CC form, mail sent to IPS with the scanned
copy, follow up request from IPS, reply to follow up information
from HCP, follow up information to IPS, reply from CCC/IPS,
reply sent to customer and any other communication with IPS/
customer

19. Are there any open cases for more than 2 months. No
Do you have documentation on follow up with the CCC/IPS for Yes
the reply.
20. Did you file a copy of NC in case of delayed reporting. The NC yes
should have all enclosures like training documents if it is the
corrective action
21. Check if the correct edition of CC forms are used yes
22. Do you have a log of SAEs reported in PMS yes
23. Do you have a local law regarding CC/AE/SAE reporting to HA. Is no
the local law described in a local procedure
24. Are all the AE/SAE reported to HA within timelines - yes
documentation

Prepared by: ROFE BA, Edition-1.0 Page 2 of 3

 Handling Potential Recall
25. Do you have a local law on handling recall no
Is the law described in any local procedure
26. Do you have a local list of recall committee no
27. Are all the employees trained in Handling potential Recall current Yes
edition – check with the current organogram
28. Do you have a procedure for distributor to handle potential recall Yes
29. Do you have recall situation in 2007, 2008 NO

Prepared by: ROFE BA, Edition-1.0 Page 3 of 3