Documentation checklist for Document Control

Sl No Document Control Ref Doc No -122642 Report

1. Do you have list of all external regulations Yes

2 Do you have local procedures in QBIQ Yes

3 Are the local procedures updated when there is change in cross yes
functional procedures?
4 Is the review of procedures documented yes
5 Are there any local procedures which are due for 3 year review, No
If yes when is review planned
6 Do you maintain applicability matrix list for all the employees. Yes
Are the lists version controlled
7 How are the employees trained in new/updated procedures By fill in the Read & Understood
before their effective date. In case of delay in training is the
reason documented
8 Is the training on QBIQ procedures documented for all the Yes
employees
9 Are the signed hard copies (originals) of local operational Yes
documents archived?
10 Are the old versions (abolished documents) marked “ABOLISH” Yes
and are archived separately
11 Do you deselect the procedures that are not applicable from your Yes
QBIQ list.
12 Do you have change requests for review and for abolish of Yes
operational documents

Prepared by: ROFE BA, Edition-1.0 Page 1 of 1