Documentation checklist for Change Control

Sl No Change Control Ref Doc No -112409; 116288 Report

1. Are all the CRs issued in 2007 and 2008 filed separately Yes
2 Do you have a log of all CRs for 2007, 2008 with the status yes
3 Do you print the log every month with the updated status and The Log has print each update
sign and date the printed log monthly.

This is to document that QA does follow up for the completion of

implementation plans
4 Check if all the CRs have CR numbers. Is the numbering system Yes, some are different numbering
in a sequence and in the correct format system ( jan-July is different to Augt
– Dec)
6 Are all the documents leading to close of CR are filed.
(eg; follow up mails/ CR4, CR6)
7 Are all the CRs closed within the timelines Some cases was extended the
Maximum of 6 months deadline
9 Are all the enclosures numbered yes
Are all the enclosures mentioned the related CR number
10 Check if all the required signatures and dates are present yes
11 Check if correct edition of CR forms are used yes
12 Are there any corrections made in the form by striking off. If yes yes
are the corrections signed and dated
13 Do you have a CR in place for all these cases if applicable Yes, review SOP
1. Review of SOP (part of 3in1 from 2008)
2. New distributor/ new contract

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 3. New/discontinuation of storage facility

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