INVESTIGATION -: QC 4TH FLOOR INSTRUMENT ROOM 3 FALL CEILING ISSUE

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Time: 12.30 to 13.30

Date: 16-sEP-20 Presenter: Sekar S Location: Qc 4th Flloor
Hrs.

Apotex Team:
Mr. Sekar Swaminathan QC
Mr. XXX-Qc
Attendees: Mr.Sunil
Mr.Mahessh JLL
Mr.Densol Team

To discuss about working structure and validation strategy of dissolution firmware 4.57i with Network
Agenda
Application.

Problem
 Discussed about working structure of Application tool through LAN for PDF print and 21 CFR part II option availability in
application tool.
 Discussed about working structure of Cloud base server/system with 21 CFR part II compliance option for data as well as
system.
Investigation below

1.

Root cause

Immediate action:
INVESTIGATION -: QC 4TH FLOOR INSTRUMENT ROOM 3 FALL CEILING ISSUE
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Permant action

Person/
ACTION ITEMS: Target Date
Dept. Responsible
 Cloud System to be send to Mr. Anuraj (Electrolab) for demo at Apotex Mr. Viral (Electrolab) 28-Aug-20

 Schedule of Service Engineer visit along with Self declaration form to be

confirmed to Apotex team Mr. Anuraj (Electrolab) 02-Sep-20

 Cloud base system demo at Apotex lab Mr. Anuraj (Electrolab) 08-Sep-20

 Arrangement of Quotation for upgradation/Qualification of Dissolution

firmware 4.57i and Installation/Qualification of Cloud base system/server with Mr. Viral (Electrolab) 08-Sep-20
all accessories